Pharmacy and Poisons Board: Applications

Protocol No.	Study Title	Principal Investigator(s)	Name of Site / County	Pages	Clear
Application Submission Dates-to- clear!

#	Protocol No	Study Title	Investigator(s) & Site(s)
446.	ECCT/08/20/01	Partners PrEP Study Parallel comparison of Tenofovir and Emtricitabine/Tenofovir pre exposure prophylaxis to prevent HIV-1 acquisition within HIV-1 discordant couples	Principal Investigator(s) 1. James Njogu Kiarie 2. CAREY FARQUHAR, 3. Grace John Stewart Site(s) in Kenya 1. Nairobi (Nairobi City county) 2. Thika (Kiambu county) 3. Eldoret (Uasin Gishu county) 4. Kisumu (Kisumu county)	View
447.	ECCT/10/09/03	A0661201 A0661201 AN OPEN LABEL, NON-COMPARATIVE STUDY TO EVALUATE PARASITOLOGICAL CLEARANCE RATES AND PHARMACOKINETICS OF AZITHROMYCIN AND CHLOROQUINE FOLLOWING ADMINISTRATION OF A FIXED DOSE COMBINATION OF AZITHROMYCIN AND CHLOROQUINE (AZCQ) IN ASYMPTOMATIC PREGNANT WOMEN WITH PLASMODIUMFALCIPARUM PARASITEMIA IN SUB-SAHARAN AFRICA	Principal Investigator(s) 1. Joshua Kimani Site(s) in Kenya University of Nairobi Institute of Tropical and Infectious Diseases Siaya District Hospital	View
448.	ECCT/12/08/01	Partners Demonstration Project An open-label, pilot demonstration and evaluation project of antiretrovira-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples.	Principal Investigator(s) 1. Dr. Nelly Rwamba Mugo Site(s) in Kenya 1. Partners in Prevention, Thika Site (Kiambu county) 2. Partners in Prevention, Kisumu Site (Kisumu county)	View
449.	ECCT/13/10/01	Clinical Trial of Acceptability, Adherence and Biologic Effects of a Vaginal Contraceptive Ring among Women in Western Kenya	Principal Investigator(s) 1. Fredrick Odhiambo Otieno 2. Lisa Ann Mills Site(s) in Kenya KEMRI/CDC Research and Public Health Collaboration	View
450.	ECCT/13/02/01	AMC 068 A Randomized Phase II Trial Of Chop Vs Oral Chemotherapy with Concomitant Antiretroviral Therapy in Patients with HIV-Associated Lymphoma in Sub-Saharan Africa	Principal Investigator(s) 1. NAFTALI WISINDI BUSAKHALA Site(s) in Kenya MOI UNIVERSITY CLINICAL RESEARCH CENTER	View

History
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Request History
4 previous requests available
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Session
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Session
- Config(array)
  userAgent9c3d2c89526db53b7b69e8c9faa06145
  time1746183146
  countdown10
====
Request
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Request

Cake Params
- plugin(null)
- controllerapplications
- actionindex
- named(array)
  page90
  approved2
- pass(empty)
- isAjax(false)
- paging(array)
  Application(array)
  page90
  current5
  count502
  prevPage(true)
  nextPage(true)
  pageCount101
  order(array)
  Application.createddesc
  limit5
  options(array)
  page90
  paramTypenamed
Post data
- Application(array)
  approved2
Query string

No querystring data.

Cookie

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Current Route
- keys(array)
  0controller
  1action
- options(empty)
- defaults(array)
  plugin(null)
- template/:controller/:action/*
====

Sql Logs

default

Total Time: 128 ms
Total Queries: 12 queries

Query	Affected	Num. rows	Took (ms)	Actions
SELECT `Application`.`id`, `Application`.`user_id`, `Application`.`trial_status_id`, `Application`.`abstract_of_study`, `Application`.`study_title`, `Application`.`laymans_summary`, `Application`.`short_title`, `Application`.`protocol_no`, `Application`.`version_no`, `Application`.`date_of_protocol`, `Application`.`study_drug`, `Application`.`disease_condition`, `Application`.`product_type_biologicals`, `Application`.`product_type_proteins`, `Application`.`product_type_immunologicals`, `Application`.`product_type_vaccines`, `Application`.`product_type_hormones`, `Application`.`product_type_toxoid`, `Application`.`product_type_chemical`, `Application`.`product_type_medical_device`, `Application`.`product_type_chemical_name`, `Application`.`product_type_medical_device_name`, `Application`.`comparator`, `Application`.`comparator_name`, `Application`.`comparator_registered`, `Application`.`comparator_countries`, `Application`.`ecct_not_applicable`, `Application`.`ecct_ref_number`, `Application`.`email_address`, `Application`.`applicant_covering_letter`, `Application`.`applicant_protocol`, `Application`.`applicant_patient_information`, `Application`.`applicant_investigators_brochure`, `Application`.`applicant_investigators_cv`, `Application`.`applicant_signed_declaration`, `Application`.`applicant_financial_declaration`, `Application`.`applicant_gmp_certificate`, `Application`.`applicant_indemnity_cover`, `Application`.`applicant_opinion_letter`, `Application`.`applicant_approval_letter`, `Application`.`applicant_statement`, `Application`.`applicant_participating_countries`, `Application`.`applicant_addendum`, `Application`.`applicant_fees`, `Application`.`applicant_complete_form`, `Application`.`applicant_impd`, `Application`.`applicant_prev_data`, `Application`.`applicant_stability_data`, `Application`.`applicant_analysis_cert`, `Application`.`applicant_pictorial_sample`, `Application`.`applicant_gcp_training`, `Application`.`applicant_dsmb_charter`, `Application`.`applicant_detailed_budget`, `Application`.`applicant_indemnity_pi`, `Application`.`applicant_practice_license`, `Application`.`applicant_registration_ctr`, `Application`.`applicant_pan_african`, `Application`.`applicant_hard_copies`, `Application`.`applicant_signed_checklist`, `Application`.`statistical_analysis_plan`, `Application`.`applicant_contractual_agreement`, `Application`.`declaration_applicant`, `Application`.`declaration_date1`, `Application`.`declaration_principal_investigator`, `Application`.`declaration_date2`, `Application`.`placebo_present`, `Application`.`study_objectives`, `Application`.`principal_inclusion_criteria`, `Application`.`principal_exclusion_criteria`, `Application`.`primary_end_points`, `Application`.`scope_diagnosis`, `Application`.`scope_prophylaxis`, `Application`.`scope_therapy`, `Application`.`scope_safety`, `Application`.`scope_efficacy`, `Application`.`scope_pharmacokinetic`, `Application`.`scope_pharmacodynamic`, `Application`.`scope_bioequivalence`, `Application`.`scope_dose_response`, `Application`.`scope_pharmacogenetic`, `Application`.`scope_pharmacogenomic`, `Application`.`scope_pharmacoecomomic`, `Application`.`scope_others`, `Application`.`scope_others_specify`, `Application`.`trial_human_pharmacology`, `Application`.`trial_administration_humans`, `Application`.`trial_bioequivalence_study`, `Application`.`trial_other`, `Application`.`trial_other_specify`, `Application`.`trial_therapeutic_exploratory`, `Application`.`trial_therapeutic_confirmatory`, `Application`.`trial_therapeutic_use`, `Application`.`design_controlled`, `Application`.`site_capacity`, `Application`.`staff_numbers`, `Application`.`other_details_explanation`, `Application`.`other_details_regulatory_notapproved`, `Application`.`other_details_regulatory_approved`, `Application`.`other_details_regulatory_rejected`, `Application`.`other_details_regulatory_halted`, `Application`.`estimated_duration`, `Application`.`design_controlled_randomised`, `Application`.`design_controlled_open`, `Application`.`design_controlled_single_blind`, `Application`.`design_controlled_double_blind`, `Application`.`design_controlled_parallel_group`, `Application`.`design_controlled_cross_over`, `Application`.`design_controlled_other`, `Application`.`design_controlled_specify`, `Application`.`design_controlled_comparator`, `Application`.`design_controlled_other_medicinal`, `Application`.`design_controlled_placebo`, `Application`.`design_controlled_medicinal_other`, `Application`.`design_controlled_medicinal_specify`, `Application`.`single_site_member_state`, `Application`.`location_of_area`, `Application`.`single_site_physical_address`, `Application`.`single_site_contact_person`, `Application`.`single_site_telephone`, `Application`.`multiple_sites_member_state`, `Application`.`multiple_countries`, `Application`.`multiple_member_states`, `Application`.`number_of_sites`, `Application`.`multi_country_list`, `Application`.`data_monitoring_committee`, `Application`.`total_enrolment_per_site`, `Application`.`total_participants_worldwide`, `Application`.`population_less_than_18_years`, `Application`.`population_utero`, `Application`.`population_preterm_newborn`, `Application`.`population_newborn`, `Application`.`population_infant_and_toddler`, `Application`.`population_children`, `Application`.`population_adolescent`, `Application`.`population_above_18`, `Application`.`population_adult`, `Application`.`population_elderly`, `Application`.`gender_female`, `Application`.`gender_male`, `Application`.`subjects_healthy`, `Application`.`subjects_patients`, `Application`.`subjects_vulnerable_populations`, `Application`.`subjects_women_child_bearing`, `Application`.`subjects_women_using_contraception`, `Application`.`subjects_pregnant_women`, `Application`.`subjects_nursing_women`, `Application`.`subjects_emergency_situation`, `Application`.`subjects_incapable_consent`, `Application`.`subjects_specify`, `Application`.`subjects_others`, `Application`.`subjects_others_specify`, `Application`.`investigator1_given_name`, `Application`.`investigator1_middle_name`, `Application`.`investigator1_family_name`, `Application`.`investigator1_qualification`, `Application`.`investigator1_professional_address`, `Application`.`investigator1_telephone`, `Application`.`investigator1_email`, `Application`.`organisations_transferred_`, `Application`.`number_participants`, `Application`.`notification`, `Application`.`approval_date`, `Application`.`submitted`, `Application`.`deleted`, `Application`.`deleted_date`, `Application`.`deactivated`, `Application`.`date_submitted`, `Application`.`is_child`, `Application`.`unsubmitted`, `Application`.`initial_date_submitted`, `Application`.`admin_stopped`, `Application`.`admin_stopped_reason`, `Application`.`approved`, `Application`.`approved_reason`, `Application`.`final_report`, `Application`.`implication_results`, `Application`.`quantity_imported`, `Application`.`quantity_dispensed`, `Application`.`quantity_destroyed`, `Application`.`quantity_exported`, `Application`.`balance_site`, `Application`.`final_date`, `Application`.`modified`, `Application`.`created`, `Application`.`total_sites`, `Application`.`ecitizen_invoice` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`approved` = 2 AND `Application`.`submitted` = '1' AND `Application`.`deactivated` = '0' AND `Application`.`deleted` = '0' ORDER BY `Application`.`created` desc LIMIT 445, 5	5	5	120	maybe slow
SELECT `InvestigatorContact`.`id`, `InvestigatorContact`.`application_id`, `InvestigatorContact`.`given_name`, `InvestigatorContact`.`middle_name`, `InvestigatorContact`.`family_name`, `InvestigatorContact`.`qualification`, `InvestigatorContact`.`professional_address`, `InvestigatorContact`.`telephone`, `InvestigatorContact`.`email`, `InvestigatorContact`.`created`, `InvestigatorContact`.`modified` FROM `ctr`.`investigator_contacts` AS `InvestigatorContact` WHERE `InvestigatorContact`.`application_id` IN (221, 216, 215, 213, 208)	8	8	2	maybe slow
SELECT `SiteDetail`.`id`, `SiteDetail`.`application_id`, `SiteDetail`.`county_id`, `SiteDetail`.`site_name`, `SiteDetail`.`physical_address`, `SiteDetail`.`contact_details`, `SiteDetail`.`contact_person`, `SiteDetail`.`site_capacity`, `SiteDetail`.`misc`, `SiteDetail`.`created`, `SiteDetail`.`modified` FROM `ctr`.`site_details` AS `SiteDetail` WHERE `SiteDetail`.`application_id` IN (221, 216, 215, 213, 208)	9	9	2	maybe slow
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 22	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 42	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 47	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 22	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 27	1	1	0
SELECT `County`.`id`, `County`.`county_name`, `County`.`created`, `County`.`modified` FROM `ctr`.`counties` AS `County` WHERE `County`.`id` = 42	1	1	0
SELECT `Sponsor`.`id`, `Sponsor`.`application_id`, `Sponsor`.`sponsor`, `Sponsor`.`sponsor_type`, `Sponsor`.`contact_person`, `Sponsor`.`address`, `Sponsor`.`telephone_number`, `Sponsor`.`fax_number`, `Sponsor`.`cell_number`, `Sponsor`.`email_address`, `Sponsor`.`created`, `Sponsor`.`modified` FROM `ctr`.`sponsors` AS `Sponsor` WHERE `Sponsor`.`application_id` IN (221, 216, 215, 213, 208)	5	5	1	maybe slow
SELECT COUNT(*) AS `count` FROM `ctr`.`applications` AS `Application` WHERE `Application`.`approved` = 2 AND `Application`.`submitted` = '1' AND `Application`.`deactivated` = '0' AND `Application`.`deleted` = '0'	1	1	3	maybe slow
SELECT `TrialStatus`.`id`, `TrialStatus`.`name` FROM `ctr`.`trial_statuses` AS `TrialStatus` WHERE 1 = 1	9	9	0

2 duplicate queries run.

Query Explain:

Click an "Explain" link above, to see the query explanation.

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Timer

Memory

Peak Memory Use 10.49 MB

Message	Memory use
Component initialization	2.39 MB
Controller action start	3.55 MB
Controller render start	4.68 MB
View render complete	5.17 MB

Timers

Total Request Time: 417 (ms)

Message	Time in ms	Graph
Core Processing (Derived from $_SERVER["REQUEST_TIME"])	108.09
Event: Controller.initialize	3.57
Event: Controller.startup	1.60
Controller action	192.16
Event: Controller.beforeRender	38.69
» Processing toolbar data	38.48
Rendering View	21.17
» Event: View.beforeRender	0.08
» Rendering APP/View/Applications/index.ctp	0.55
» » Rendering APP/View/Elements/google-recommend.ctp	0.15
» Rendering APP/View/Elements/application/public_index.ctp	14.42
» Event: View.afterRender	0.05
» Event: View.beforeLayout	0.05
» Rendering APP/View/Layouts/default.ctp	5.06
» » Rendering APP/View/Elements/google-analytics.ctp	0.18
Event: View.afterLayout	0.00

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Log
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Logs

There were no log entries made this request

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Variables
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View Variables
- trial_statuses(array)
 1Recruiting
 2Not yet recruiting
 3Suspended
 4Stopped
 5Completed
 6In follow-up
 7Analysing
 8Writing-up
 9Application withdrawn
- applications(array)
 0(array)
 Application(array)
 id221
 user_id98
 trial_status_id5
 abstract_of_study<div data-canvas-width=\"70.23521854019165\" data-font-name=\"g_font_75_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: sans-serif; left: 82.6667px; top: 396.559px; transform: scale(1.06417, 1); transform-origin: 0% 0% 0px;\">\n Background</div>\n<div data-canvas-width=\"447.92438385963464\" data-font-name=\"g_font_72_0\" dir=\"ltr\" style=\"font-size: 13.3333px; font-family: serif; left: 82.6667px; top: 427.892px; transform: scale(1.01295, 1); transform-origin: 0% 0% 0px;\">\n Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations.</div>\n<div data-canvas-width=\"5.567938049316407\" data-font-name=\"g_font_146_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: monospace; left: 127.738px; top: 448.559px; transform: scale(0.79542, 1); transform-origin: 0% 0% 0px;\">\n </div>\n<div data-canvas-width=\"5.567938049316407\" data-font-name=\"g_font_146_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: monospace; left: 127.738px; top: 448.559px; transform: scale(0.79542, 1); transform-origin: 0% 0% 0px;\">\n Methods</div>\n<div data-canvas-width=\"221.51557414627075\" data-font-name=\"g_font_72_0\" dir=\"ltr\" style=\"font-size: 13.3333px; font-family: serif; left: 82.6667px; top: 575.892px; transform: scale(1.00819, 1); transform-origin: 0% 0% 0px;\">\n We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1–serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1–seronegative partner in each couple was randomly assigned to one of three study regimens — once-daily tenofovir (TDF), combination tenofovir– emtricitabine (TDF–FTC), or matching placebo — and followed monthly for up to 36 months. At enrollment, the HIV-1–seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services.</div>\n<div data-canvas-width=\"42.34752882766724\" data-font-name=\"g_font_75_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: sans-serif; left: 82.6667px; top: 596.559px; transform: scale(0.984826, 1); transform-origin: 0% 0% 0px;\">\n </div>\n<div data-canvas-width=\"42.34752882766724\" data-font-name=\"g_font_75_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: sans-serif; left: 82.6667px; top: 596.559px; transform: scale(0.984826, 1); transform-origin: 0% 0% 0px;\">\n Results</div>\n<div data-canvas-width=\"185.74295554542536\" data-font-name=\"g_font_72_0\" dir=\"ltr\" style=\"font-size: 13.3333px; font-family: serif; left: 348.955px; top: 771.892px; transform: scale(1.00947, 1); transform-origin: 0% 0% 0px;\">\n We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned toTDF, 1579 to TDF–FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1–seronegative partner was male. Among HIV-1–seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF–FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF–FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF–FTC and TDF alone against HIV-1 were not significantly different (P =0.23), and both study medications</div>\n<div data-canvas-width=\"447.93771692657475\" data-font-name=\"g_font_72_0\" dir=\"ltr\" style=\"font-size: 13.3333px; font-family: serif; left: 82.68px; top: 835.892px; transform: scale(1.01982, 1); transform-origin: 0% 0% 0px;\">\n significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline,and among these eight, antiretroviral resistance developed in two during the study.</div>\n<div data-canvas-width=\"73.4751824913025\" data-font-name=\"g_font_75_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: sans-serif; left: 82.6667px; top: 856.559px; transform: scale(1.04965, 1); transform-origin: 0% 0% 0px;\">\n </div>\n<div data-canvas-width=\"73.4751824913025\" data-font-name=\"g_font_75_0\" dir=\"ltr\" style=\"font-size: 12px; font-family: sans-serif; left: 82.6667px; top: 856.559px; transform: scale(1.04965, 1); transform-origin: 0% 0% 0px;\">\n Conclusions</div>\n<div data-canvas-width=\"451.95097007560736\" data-font-name=\"g_font_72_0\" dir=\"ltr\" style=\"font-size: 13.3333px; font-family: serif; left: 82.6667px; top: 887.892px; transform: scale(0.978072, 1); transform-origin: 0% 0% 0px;\">\n Oral TDF and TDF–FTC both protect against HIV-1 infection in heterosexual menand women.</div>\n
 study_title\n Parallel comparison of Tenofovir and Emtricitabine/Tenofovir pre exposure prophylaxis to prevent HIV-1 acquisition within HIV-1 discordant couples\n
 laymans_summary(null)
 short_titlePartners PrEP Study
 protocol_noECCT/08/20/01
 version_no3
 date_of_protocol12-10-2007
 study_drugTenofovir and Emtricitabine/Tenofovir
 disease_conditionpre exposure prophylaxis against HIV
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameTenofovir and Emtricitabine/Tenofovir
 product_type_medical_device_name
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 ecct_not_applicable0
 ecct_ref_number
 email_addressakaggiah@gmail.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter0
 applicant_statement1
 applicant_participating_countries0
 applicant_addendum0
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd(null)
 applicant_prev_data(null)
 applicant_stability_data(null)
 applicant_analysis_cert(null)
 applicant_pictorial_sample(null)
 applicant_gcp_training(null)
 applicant_dsmb_charter(null)
 applicant_detailed_budget(null)
 applicant_indemnity_pi(null)
 applicant_practice_license(null)
 applicant_registration_ctr(null)
 applicant_pan_african(null)
 applicant_hard_copies(null)
 applicant_signed_checklist(null)
 statistical_analysis_plan(null)
 applicant_contractual_agreement(null)
 declaration_applicantProf. James Kiarie/Dr. Anne Kaggiah
 declaration_date110-10-2013
 declaration_principal_investigatorJared Baeten
 declaration_date210-10-2013
 placebo_presentYes
 study_objectives(null)
 principal_inclusion_criteria\n Inclusion Criteria for HIV-1 uninfected partner:\n<ul style=\"margin-top:1ex; margin-bottom:1ex;\">\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Partner within an HIV-1 discordant heterosexual relationship</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Plan to remain in the relationship for the duration of the study period</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Adequate renal, hepatic & hematologic function</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Negative Hepatitis B surface antigen test</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Willing and able to provide written informed consent & locator information</li>\n</ul>\n\n \n\n Inclusion Criteria for HIV-1 infected partner:\n<ul style=\"margin-top:1ex; margin-bottom:1ex;\">\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Partner within an HIV-1 discordant heterosexual relationship</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n One partner meets study eligibility for HIV-1 uninfected study participant and the other partner meets study eligibility criteria for HIV-1 infected participant</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n HIV-1 infected based on positive EIA</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n No history of any clinical AIDS-defining diagnoses</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Plan to remain in the relationship for the duration of the study period</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Willing and able to provide written informed consent & locator information</li>\n</ul>\n
 principal_exclusion_criteria\n Exclusion Criteria for HIV-1 uninfected partner:\n<ul style=\"margin-top:1ex; margin-bottom:1ex;\">\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Current pregnancy, or planning to become pregnant during the study period</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Currently breastfeeding</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Concurrent enrollment in another HIV-1 vaccine or prevention trial</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Receiving ongoing antiretroviral therapy</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Repeated positive urine dipstick tests for glycosuria or proteinuria</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Active and serious infections</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n History of pathological bone fractures not related to trauma</li>\n</ul>\n\n \n\n Exclusion Criteria for HIV-1 infected partner:\n<ul style=\"margin-top:1ex; margin-bottom:1ex;\">\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Current use of antiretroviral therapy</li>\n <li class=\"color-bullet\" style=\"margin-top:0.7ex;\">\n Concurrent enrollment in another HIV-1 treatment trial</li>\n</ul>\n\n \n
 primary_end_points\n 1. HIV infection among HIV uninfected partner (seroconversion)\n
 scope_diagnosis0
 scope_prophylaxis1
 scope_therapy0
 scope_safety1
 scope_efficacy1
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use0
 design_controlledYes
 site_capacity(null)
 staff_numbers\n Prof. James Kiarie - Principle Investigator- MBCHB, MMED,MPH\n\n Anne Kaggiah - Study coordinator - MD\n\n Milcah Ariongo- Study administrator - Bsc. Nursing\n\n William Obara - lab manager\n\n Jerusha Malubi - Data manager - Community Nursing\n\n Shiphrah Maina - Retention manager - Social sciencea\n\n Grace Wambugu - Pharmcay technologist\n\n Joseph - Driver\n\n Site facilites - reception, pharmacy, labaroratory, 6 clinic rooms, 2 counseling rooms, data room, one vehicle\n
 other_details_explanation\n Majority of new HIV infections are in Africa occur among HIV discordant couples. This was validated in 2005 in a Ugandan population based serosurvey which showed upto 65% of incident infections occur among married couples.\n\n Only a trial among HIV discordant couples can examine the impact of biological and behavioural characteristics of both HIV susceptible and infected partners on the efficacy of pre exposure prophylaxis.\n
 other_details_regulatory_notapproved\n Not applicable\n
 other_details_regulatory_approved\n Kenyatta National Hospital/University of Nairobi Ethics and Research Committee - Dates of approval- 9th October 2008, 9th October 2009, 9 October 2010, 9th October 2011, 9th October 2012, 9th October 2013\n\n University of Washington Review Board - Dates of approval - 8th December 2008, 8th Dec 2009, 8th Dec 2010, 8th Dec 2011, 8th Dec 2012\n\n University of Wahington Human Subject Division- Dates of approval - 28th Sep 2008, 28th Sep 2009, 28th Sep 2010, 28th Sep 2011, 28th Sep 2012, 28th Sep 2013\n\n Pharmacy Board of Kenya - Dates of approval- 11th Oct 2008, 11th Oct 2009, 11th Oct 2010, 11th Oct 2011, 11th Oct 2012\n
 other_details_regulatory_rejected\n Not applicable\n
 other_details_regulatory_halted\n Not applicable\n
 estimated_duration4 years
 design_controlled_randomisedYes
 design_controlled_openNo
 design_controlled_single_blindNo
 design_controlled_double_blindYes
 design_controlled_parallel_groupYes
 design_controlled_cross_overNo
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorActive Comparator: I Drug
 design_controlled_other_medicinalNo
 design_controlled_placeboYes
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states2
 number_of_sites4
 multi_country_listUganda \nKenya
 data_monitoring_committeeYes
 total_enrolment_per_siteEldoret-488 HIV-1 discordant couples, Kisumu -629 HIV-1 discordant couples, Nairobi- 485 HIV-1 discordant couples, Thika - 496 HIV-1 discordant couples
 total_participants_worldwide4758 HIV-1 discordant couples
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male1
 subjects_healthyYes
 subjects_patientsNo
 subjects_vulnerable_populationsNo
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionNo
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameAndrew
 investigator1_middle_name
 investigator1_family_nameMujugira
 investigator1_qualification MBChB MSc MPH
 investigator1_professional_addressKampala
 investigator1_telephone+256 754 173 225
 investigator1_emailmujugira@uw.edu
 organisations_transferred_No
 number_participants2098 HIV-1 discordant couples
 notification
 approval_date09-10-2013
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted19-10-2013
 is_child0
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reason
 final_report\n Sponsor:Bill and Melinda Gates Foundation\n<h4 class=\"text-success\" style=\"margin: 10px 0px; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; line-height: 20px; color: rgb(70, 136, 71); text-rendering: optimizelegibility; font-size: 17.5px;\">\n ECCT/08/20/01</h4>\n\n Summary\n\n Objective:\n\n This research studied two medications that suppress the HIV virus. One medication called Tenofovir and second medication was a combination of Tenofovir and Emtricitabine. The combination was known as Truvada®. Tenofovir and Truvada® are pills used to treat people already infected with HIV. Studies showed that these medications were safe when used once per day as treatment of HIV by HIV-infected people. Tenofovir and Truvada® are not cures for HIV, but they are very effective in suppressing HIV in people who are infected and in improving their health and immune function.\n\n \n\n The purpose the study was to find out if taking Tenofovir or Truvada® every day coulf prevent HIV-uninfected men and women from getting the HIV virus from their infected partner. This is called pre-exposure prophylaxis. The study also determined whether Tenofovir and Truvada were safe and do not produce health problems when taken by HIV-uninfected men and women.\n\n \n\n Population:\n\n 4758 couples, all from Africa, were enrolled in the parent study. All the couples were HIV-discordant, meaning that one person had HIV and the other person did not have HIV. The enrolment goal at the Nairobi site was to enroll 500-800 couples as subjects. 485 couples were enrolled at the Nairobi site at the close of enrolment. The HIV infected subjects must have had a CD4 count ≥250 cells/mm3 and must not have otherwise qualified for initiation of ART at the time of study screening and enrollment. The HIV-1 uninfected partner in the couple must have reported an average of 6 times vaginal intercourse with the partner in the 3 months prior to screening and enrolment. Eligibility determination of the HIV-1 uninfected partner included normal renal, liver, and haematologic function based on clinical and laboratory screening. The HIV-1 uninfected partner must have been uninfected with hepatitis B. Hepatitis B seronegative participants were offered hepatitis B vaccination at no cost.\n\n \n\n Procedures\n\n Each eligible participant underwent a physical examination. For women, samples from the genital area were collected to test for sexually transmitted infections. A pap smear was also performed. A urine sample was used for a pregnancy test. For men, a urine test was used to test for sexually transmitted infections. Both men and women were asked permission to obtain a blood sample of up to 29.5ml-about 2 tablespoons. The blood sample were used for HIV, syphilis, hepatitis B and Herpes Simplex virus test.\n\n After the enrolment visit, each participant was scheduled for a follow-up visit. The HIV-uninfected participants were followed up monthly. HIV-1 rapid testing was performed, in the context of pre-test, risk reduction and post test counseling. Counseling included reminders to contact study staff with questions, as well as counseling not to share the study medication.\n\n For women, a pregnancy test was performed at these monthly visits and counseling about contraceptives. In the event of a positive pregnancy test, the study medication was stopped.\n\n Follow-up visit for HIV-infected participants occured quarterly. During these visits, a physical exam was performed and the participants were asked questions about their sexual practices and educated on ways to avoid HIV and other sexually transmitted infections. If needed, participants received medical care or referrals and other services.\n\n All participants received couple counseling at screening, enrollment, and during follow-up that include counseling about risks for transmission and strategies to reduce the risk of transmission. Participants underwent genital exams, HIV-1 and STI counseling and testing, STI treatment, and HBV vaccination if indicated. They were offered participation in support groups for HIV-1 infected and HIV-1 uninfected persons and also provided with condoms and STI treatment free of charge.\n\n Each couple was in the study for a minimum of 24 months and up to a maximum of 36 months. Those who become HIV infected during the study were asked to continue follow-up for one year after infection, regardless of when during the 36 months of maximum follow-up the HIV infection occured. \n\n Starting 1 June 2012, close out of the study began. Active arm participants started having a STOP visit at their next quarterly visit that is at least month 24 (consistent with the informed consent). Approximately half of active arm participants had already completed 36 months of follow-up; thus, the remainder exited at/after month 24. Under this schedule, most of the remaining half will exited in June, July, and August, with a small number in September. Placebo conversion enrolees were followed through 12 study months – ending between September and December 2012, depending on when they were re-randomized. Therefore, all participants (including placebo conversion participants) completed follow up before 30 December 2012,i.e, all study visits. The study drugs and placebos were destroyed as per the Pharmacy and Poisons Board regulations and supervision in 2012.\n\n Since then the study team has been appying for annual renewal for data analysis from the respective IRB authorities. Attached with these summary is the progress report for various publications.\n
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 modified2019-09-10 12:18:19
 created2013-10-09 12:20:14
 total_sites(null)
 ecitizen_invoice(null)
 InvestigatorContact(array)
 0(array)
 id151
 application_id221
 given_nameJames
 middle_nameNjogu
 family_nameKiarie
 qualificationMBCHB, MMED, MPH
 professional_addressP.O Box 202723-00202
 telephone0733771288
 emailjkiarie@swiftkenya.com
 created2013-10-09 12:47:49
 modified2013-10-19 13:24:08
 1(array)
 id152
 application_id221
 given_nameCAREY
 middle_name
 family_nameFARQUHAR,
 qualificationMD, MPH
 professional_address325 9th Avenue, Box 359909, Seattle, WA 98104
 telephone(206) 543-4278
 emailcfarq@u.washington.edu
 created2013-10-10 17:52:09
 modified2013-10-19 13:24:08
 2(array)
 id153
 application_id221
 given_nameGrace
 middle_nameJohn
 family_nameStewart
 qualificationB.S. M.D., M.P.H., Ph.D.,
 professional_address325 Ninth Ave, Box 359909Seattle, Washington 98104-2499
 telephone 206-543-4278
 emailgjohn@u.washington.edu
 created2013-10-10 17:53:55
 modified2013-10-19 13:24:08
 SiteDetail(array)
 0(array)
 id190
 application_id221
 county_id47
 site_nameNairobi
 physical_addressKNH opposite KNH Police station
 contact_detailsP.O Box 20723-00202
 contact_personAnne Kaggiah
 site_capacity(null)
 misc(null)
 created2013-10-09 12:47:49
 modified2013-10-19 13:24:08
 County(array)
 id47
 county_nameNairobi City
 created2012-06-15 10:27:40
 modified2012-06-15 10:27:40
 1(array)
 id191
 application_id221
 county_id22
 site_nameThika
 physical_addressThika town opposite Tuskys
 contact_details254 6722561
 contact_personKenneth Ngure
 site_capacity(null)
 misc(null)
 created2013-10-09 17:20:46
 modified2013-10-19 13:24:08
 County(array)
 id22
 county_nameKiambu
 created2012-06-15 10:24:37
 modified2012-06-15 10:24:37
 2(array)
 id192
 application_id221
 county_id27
 site_nameEldoret
 physical_addressEldoret Town
 contact_details254 53 5361101
 contact_personDismas oketch
 site_capacity(null)
 misc(null)
 created2013-10-09 17:20:46
 modified2013-10-19 13:24:08
 County(array)
 id27
 county_nameUasin Gishu
 created2012-06-15 10:25:15
 modified2012-06-15 10:25:15
 3(array)
 id193
 application_id221
 county_id42
 site_nameKisumu
 physical_addressKisumu Town
 contact_details254 572 021 036
 contact_personJosephine Odoyo
 site_capacity(null)
 misc(null)
 created2013-10-09 17:20:46
 modified2013-10-19 13:24:08
 County(array)
 id42
 county_nameKisumu
 created2012-06-15 10:27:02
 modified2012-06-15 10:27:02
 Sponsor(array)
 0(array)
 id119
 application_id221
 sponsorUniversity of Wahington
 sponsor_type(null)
 contact_personConnie Celum
 addressP.O Box 359927 Cabrini Medical Tower, Suite 1300 901 Boren Avenue Seattle Washington 98104
 telephone_number206 5203825
 fax_number
 cell_number206 520381
 email_addressccelum@u.wahington.edu
 created2013-10-09 12:47:49
 modified2013-10-19 13:24:08
 1(array)
 Application(array)
 id216
 user_id90
 trial_status_id4
 abstract_of_study\n Intermittent preventive treatment of falciparum malaria in pregnant women (IPTp).\n\n Background and Rationale\n\n Malaria is a serious protozoal infection caused by any of the five species of Plasmodia and\n\n transmitted by anopheline mosquitoes; it continues to be one of the largest global health\n\n problems.1 2 As per the World Health Organization (WHO) World Malaria Report 2009,3\n\n about half of the world's population is at risk of infection in 108 endemic countries and\n\n territories. In 2008, there were an estimated 243 million cases and 863,000 malaria-related\n\n deaths.3 Malaria in pregnancy (MIP) is one of the most common causes of preventable\n\n mortality and morbidity in pregnant women and infants in sub-Saharan Africa. An estimated\n\n 30 million pregnancies are at risk of malaria infection in sub-Saharan Africa each year;4\n\n about 200,000 infants and 10,000 women die of malaria in pregnancy each year.5\n\n Important progress has been made in the control of malaria in pregnancy in Africa with the\n\n introduction of intermittent preventive treatment in pregnancy (IPTp). The WHO\n\n recommends the administration of IPTp with sulfadoxine-pyrimethamine (SP) during\n\n antenatal visits in high malaria transmission areas of sub-Saharan Africa.6 However, SP\n\n resistance has become widespread especially in East and Southern Africa, greatly limiting the\n\n protective effect of IPTp with SP. The development of safe, efficacious and affordable\n\n replacement of SP for IPTp is an urgent priority.\n\n The combination of azithromycin (AZ) and chloroquine (CQ) could potentially replace\n\n SP for IPTp. AZ and CQ are synergistic in vitro and in vivo against CQ resistant strains of\n\n P. falciparum. Co-administration of AZ and CQ has demonstrated efficacy, safety and\n\n tolerability in two multi-country Phase 3 clinical studies (A0661134 and A0661155) in the\n\n treatment of symptomatic uncomplicated malaria in non-pregnant adults in sub-Saharan\n\n Africa. AZ and CQ have been on the market for several years and have extensive safety\n\n records in adults, children and pregnant women. Both AZ and CQ have been widely used in\n\n all trimesters of pregnancy and are considered safe in pregnant women as individual agents.\n\n In high-income countries, AZ is commonly used to treat and prevent sexually transmitted\n\n infections (STIs) including Neisseria gonorrhoeae and Chlamydia trachomatis infections. In\n\n sub-Saharan Africa, two randomized controlled clinical trials.21, 22 found that a single dose of\n\n 1000 mg AZ was comparable to benzathine penicillin G in curing syphilis. The incidence of\n\n adverse fetal outcomes has been shown to be reduced by about 30% when these three STIs\n\n were treated in pregnancy.23 In addition, AZ has also demonstrated protective effect against\n\n Trichomonas vaginalis when used as chemoprophylaxis24 and reduced the risk of preterm\n\n delivery attributable to T. vaginalis, even in the second trimester when first-line treatment,\n\n metronidazole, should be avoided.25\n\n 090177e1811d3ccb\\Approved\\Approved On: 19-Feb-2010 20:59\n\n Azithromycin/Chloroquine Combination\n\n A0661201\n\n Final Protocol, 14 February 2010\n\n PFIZER CONFIDENTIAL\n\n Page 3\n\n A fixed dose combination tablet formulation of AZ and CQ (AZCQ, 250 mg AZ/155 mg\n\n CQ base) has been developed specifically for the IPTp indication and will be evaluated in\n\n IPTp studies. In a clinical pharmacology study A0661186, AZCQ administration resulted in\n\n the systemic exposures to AZ, CQ and des-ethyl CQ (an active metabolite of CQ) at levels\n\n comparable to those achieved following administration of commercial standalone tablets of\n\n AZ (Zithromax) and CQ (Aralen) evaluated in adult treatment studies.\n\n A Phase 3 randomized controlled clinical study to demonstrate the superiority of AZCQ IPTp\n\n regimen over SP IPTp regimen is planned in East and Southern sub-Saharan Africa where SP\n\n resistance is emerging as an issue and where SP is the current standard of care for IPTp. This\n\n will be the pivotal study for regulatory submissions to European Medicines Agency (EMA)\n\n and to the national regulatory agencies in Sub-Saharan African countries.\n\n AZCQ is expected to exert IPTp effect through multiple mechanisms including peripheral\n\n parasitological clearance in pregnant women, prevention of re-infections,\n\n prevention/treatment of placental malaria and prevention/treatment of STIs. The relative\n\n contributions of these mechanisms towards IPTp effect are not yet known. The study\n\n A0661201 is an open label, non-comparative parasitological clearance study of a single\n\n 3-day treatment course of AZCQ in about 166 pregnant women in second and third trimesters\n\n of pregnancy with asymptomatic parasitemia. This study will help to characterize the\n\n magnitude of parasitological clearance required for the IPTp effect observed in A0661158\n\n study, and will serve as a supportive study in IPTp regulatory dossier. A0661201 study will\n\n also evaluate pharmacokinetic (PK) exposures, of both AZ and CQ in pregnant women\n\n following administration of a single 3-day treatment course of AZCQ. Subjects will be\n\n followed up to Day 42 after the first dose, and followed through delivery or to pregnancy\n\n termination for safety assessments of Exposure in Utero (EIU).\n
 study_title\n A0661201\n\n AN OPEN LABEL, NON-COMPARATIVE STUDY TO EVALUATE PARASITOLOGICAL CLEARANCE RATES AND PHARMACOKINETICS OF AZITHROMYCIN AND CHLOROQUINE FOLLOWING ADMINISTRATION OF A FIXED DOSE COMBINATION OF AZITHROMYCIN AND CHLOROQUINE (AZCQ) IN ASYMPTOMATIC PREGNANT WOMEN WITH PLASMODIUMFALCIPARUM PARASITEMIA IN SUB-SAHARAN AFRICA\n
 laymans_summary(null)
 short_titleA0661201
 protocol_noECCT/10/09/03
 version_noVesrion 1 Final 14 February 2010
 date_of_protocol14-02-2010
 study_drugAzithromycin/Chloroquine Combination
 disease_conditionMalaria
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameAZCQ
 product_type_medical_device_name
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 ecct_not_applicable0
 ecct_ref_number
 email_addressjkimani@csrtkenya.org
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter0
 applicant_statement1
 applicant_participating_countries0
 applicant_addendum0
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd(null)
 applicant_prev_data(null)
 applicant_stability_data(null)
 applicant_analysis_cert(null)
 applicant_pictorial_sample(null)
 applicant_gcp_training(null)
 applicant_dsmb_charter(null)
 applicant_detailed_budget(null)
 applicant_indemnity_pi(null)
 applicant_practice_license(null)
 applicant_registration_ctr(null)
 applicant_pan_african(null)
 applicant_hard_copies(null)
 applicant_signed_checklist(null)
 statistical_analysis_plan(null)
 applicant_contractual_agreement(null)
 declaration_applicantDr Joshua Kimani; University of Nairobi Institute of Tropical and Infectious Diseases, College of Health Sciences, University of Nairobi, Nairobi & Siaya County Referral Hospital, Siaya, Kenya
 declaration_date121-02-2014
 declaration_principal_investigatorDr Joshua Kimani, University of Nairobi Institute of Tropical and Infectious Diseases, College of Health Sciences, University of Nairobi, Nairobi, Kenya & Siaya County Referral Hospital, Siaya, Kenya
 declaration_date221-02-2014
 placebo_presentNo
 study_objectives(null)
 principal_inclusion_criteria\n 1. Primigravidae and secundigravidae pregnant women at ï‚³14 and ï‚£30 weeks of\n\n gestational age (confirmed by ultrasound examination).\n\n 2. Evidence of asymptomatic parasitemia with Plasmodium falciparum monoinfection (confirmed by microscopy) with parasite counts in the range of 80-100,000/ïL on thick blood smears.\n\n 3. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is <18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age.\n\n 4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\n 5. Subjects who agree to be supervised for treatment administration, and are available for all follow up visits as per protocol.\n
 principal_exclusion_criteria\n Subjects presenting with any of the following will not be randomized in the study:\n\n 1. Age <16 years old or >35 years old.\n\n 2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.\n\n 3. Clinical symptoms of malaria.\n\n 4. Hemoglobin <8 g/dL (measured at baseline).\n\n 5. Any condition requiring hospitalization or evidence of severe concomitant infection\n\n at time of presentation.\n\n 6. Use of antimalarial drugs in previous 4 weeks.\n\n 7. History of convulsions, hypertension, diabetes or any other chronic illness that may\n\n adversely affect fetal growth and viability.\n\n 8. Inability to tolerate oral treatment in tablet form.\n\n 9. Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or\n\n sulphonamides.\n\n 10. Present history of smoking or alcohol or drug abuse since becoming pregnant.\n\n 11. Participation in other studies within 30 days before the current study begins and/or\n\n during study participation.\n\n 12. Inability to comprehend and/or unwillingness to follow the study protocol.\n\n 13. Concurrent participation in another investigational study.\n\n 14. Previously randomized in this study.\n\n 15. Requirement to use medication during the study that might interfere with the\n\n evaluation of the study drug of AZ or CQ or is contra-indicated during pregnancy per\n\n package inserts.\n\n 16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality\n\n that may increase the risk associated with study participation or investigational\n\n product administration or may interfere with the interpretation of study results and, in\n\n the judgment of the investigator, would make the subject inappropriate for entry into\n\n this study. Examples would include but not limited to:\n\n a. Symptomatic HIV infection, including physical findings that suggest\n\n immunocompromised status (eg, oral candidiasis);\n\n b. Neurological conditions which may predispose to complications during\n\n pregnancy, including seizure disorders;\n\n c. Severe psychosis or major disorder that may interfere with the conduct of the\n\n study or adherence to study medication;\n\n d. Known, clinically significant pre-existing renal or hepatic disease.\n\n 17. Evidence of current obstetric complications that may adversely impact the pregnancy\n\n and/or fetal outcomes, including presence of congenital anomalies, placenta previa or\n\n abruption.\n\n 18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.\n\n 19. Known family history of prolonged QT syndrome, serious ventricular arrhythmia, or\n\n sudden cardiac death.\n\n \n
 primary_end_points\n Primary Efficacy Endpoint\n\n ï‚· Parasitological response (PCR corrected) at Day 28 post first dose of study\n\n medication.\n
 scope_diagnosis0
 scope_prophylaxis0
 scope_therapy0
 scope_safety0
 scope_efficacy0
 scope_pharmacokinetic1
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory1
 trial_therapeutic_use0
 design_controlledNo
 site_capacity(null)
 staff_numbers\n UoN/Siaya District Hospital based clinical trial team and key roles\n\n \n\n \n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:540px;\" width=\"540\">\n <tbody>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Study Team Members\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Designation\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Joshua Kimani\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Principal Investigator\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Prof. Benson Estambale\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Co- Principal Investigator\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Omoto Jackton\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Co- Principal Investigator\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n SITE CO-ORDINATOR\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Jacqueleen Wanjiru\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Site Coordinator\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n SUB INVESTIGATORS\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Annette Metho\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Medical Officer\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Jeremy Omondi\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Consultant Pediatrician\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Joan Muyoki Ngichabe\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Medical Officer \n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n CLINICAL TEAM\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Benard Wasonga\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Nurse\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Fredrick Oduor Ogutu\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Nurse\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Michael Otieno Abonyo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Clinical Officer\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Sharon Chebet\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Nurse\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Maurice Wanga\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Nurse\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Jacktone Ogutu Okich\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Clinical Officer\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Linah Oule\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Nurse\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n LABORATORY TEAM\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n George Githongo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Laboratory Manager\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Benson Odhiambo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Laboratory Technologist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n James Kariuki Ndwiga\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Laboratory Assistant\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Olewe Perez Kola\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Laboratory Technologist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Vivian A Owino\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Microscopist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Daniel Muyale\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Microscopist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n PHARMACY\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Geoffrey Mwai\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Pharmacist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Dr. Eunice Fwaya\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Pharmacist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Jeremiah Muriuki\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Pharmaceutical Technologist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n SOCIO – WORK TEAM\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Bilhah M Wanjiru\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Social Scientist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Regina Akoth\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Social Scientist\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n PMTCT-VCT COUNSELLLORS\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Pamela Valerie Adhiambo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Counselor\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n \n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n ULTRASONOGRAPHER\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Cheptoo Eglah\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Ultrasonographer\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Shadrack Ayieko\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Ultrasonographer\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td colspan=\"2\" nowrap=\"nowrap\" style=\"width:511px;height:20px;\">\n \n SUPPORT STAFF\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Bernard P Akombi\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Driver\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Emily Awour Aloo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Office Assistant\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Anne Adhiambo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Office Assistant\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Magdalene Kamau\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Office Assistant\n </td>\n </tr>\n <tr>\n <td nowrap=\"nowrap\" style=\"width:29px;height:20px;\">\n \n \n </td>\n <td nowrap=\"nowrap\" style=\"width:230px;height:20px;\">\n \n Simon Dzombo\n </td>\n <td nowrap=\"nowrap\" style=\"width:281px;height:20px;\">\n \n Driver\n </td>\n </tr>\n </tbody>\n</table>\n\n \n
 other_details_explanation\n No Malaria in the USA\n
 other_details_regulatory_notapproved\n Non, all Regulatory Authorities approved the study.\n
 other_details_regulatory_approved\n \n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width: 123px\">\n \n Country\n </td>\n <td style=\"width: 177px\">\n \n Name of Regulatory Body\n </td>\n <td style=\"width: 69px\">\n \n Number of sites\n </td>\n <td style=\"width: 167px\">\n \n Date of approval\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n \n Benin\n </td>\n <td style=\"width: 177px\">\n \n MoH Department of Training in Health (Ministère de la Santé Direction de la Recherche en Santé)\n </td>\n <td style=\"width: 69px\">\n \n 1\n </td>\n <td style=\"width: 167px\">\n \n 23 Dec 2010\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n \n Malawi\n </td>\n <td style=\"width: 177px\">\n \n Pharmacy Medicines and Poisons Board\n </td>\n <td style=\"width: 69px\">\n \n 1\n </td>\n <td style=\"width: 167px\">\n \n 20 Sept 2011\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n \n Uganda\n </td>\n <td style=\"width: 177px\">\n \n National Drug Authority\n </td>\n <td style=\"width: 69px\">\n \n 1\n </td>\n <td style=\"width: 167px\">\n \n 16 March 2012\n </td>\n </tr>\n <tr>\n <td style=\"width: 123px\">\n \n Tanzania\n </td>\n <td style=\"width: 177px\">\n \n Tanzania Food and Drug Authority\n </td>\n <td style=\"width: 69px\">\n \n 2\n </td>\n <td style=\"width: 167px\">\n \n 14 April 2011\n </td>\n </tr>\n </tbody>\n</table>\n\n \n
 other_details_regulatory_rejected\n Not Applicable\n
 other_details_regulatory_halted\n Not Applicable\n
 estimated_duration07 March 2011 to 30 April 2013
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_stateYes
 location_of_areaUniversity of Nairobi Institute of Tropical and Infectious Diseases Siaya District Hospital
 single_site_physical_address Siaya District Hospital ,P.O. Box 144-40600, Siaya, Kenya
 single_site_contact_personDr Joshua Kimani
 single_site_telephone+254 733 719711
 multiple_sites_member_stateNo
 multiple_countriesYes
 multiple_member_states4
 number_of_sites
 multi_country_listUganda, Malawi, Tanzania, Benin
 data_monitoring_committeeYes
 total_enrolment_per_site80
 total_participants_worldwide166
 population_less_than_18_yearsYes
 population_uteroYes
 population_preterm_newbornYes
 population_newbornYes
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male0
 subjects_healthyNo
 subjects_patientsNo
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionNo
 subjects_pregnant_womenYes
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameJoshua
 investigator1_middle_name
 investigator1_family_nameKimani
 investigator1_qualificationMB Ch. B, MPH (Epidemiology)
 investigator1_professional_addressUniversity of Nairobi Institute of Tropical and Infectious Diseases(UNITID), College of Health Sciences, University of Nairobi, Nairobi, Kenya
 investigator1_telephone+254 20 234 1108
 investigator1_emailjkimani@csrtkenya.org
 organisations_transferred_Yes
 number_participants80
 notification
 approval_date25-09-2013
 submitted1
 deleted0
 deleted_date2014-02-20 18:15:20
 deactivated0
 date_submitted21-02-2014
 is_child0
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reason
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 modified2018-07-07 15:05:38
 created2013-09-25 18:03:29
 total_sites(null)
 ecitizen_invoice(null)
 InvestigatorContact(array)
 0(array)
 id150
 application_id216
 given_nameJoshua
 middle_name
 family_nameKimani
 qualificationMB ChB, MPH( Epidemiology)
 professional_addressUniversity of Nairobi Institute of Tropical and Infectious Diseases (UNITID), College of Health Sciences ,Nairobi, Kenya
 telephone0733719711
 emailjkimani@csrtkenya.org
 created2013-09-26 12:04:23
 modified2014-02-21 15:00:36
 SiteDetail(array)
 0(array)
 id189
 application_id216
 county_id(null)
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 contact_details
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 site_capacity(null)
 misc(null)
 created2013-09-26 12:04:23
 modified2014-02-21 15:00:36
 County(empty)
 Sponsor(array)
 0(array)
 id118
 application_id216
 sponsorPfizer
 sponsor_type(null)
 contact_personRicardo Rojo Cella
 address445 Eastern Point Rd, Groton CT USA, 06340
 telephone_number8604410547
 fax_number
 cell_number 8609106576
 email_addressRicardo.rojo@pfizer.com
 created2013-09-26 12:04:23
 modified2014-02-21 15:00:36
 2(array)
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 id215
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 trial_status_id7
 abstract_of_study<div>\n Antiretroviral-based HIV-1 prevention strategies – including</div>\n<div>\n 1) antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and</div>\n<div>\n 2) pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected). Stable, heterosexual African HIV-1 serodiscordant couples face high risk of HIV-1 transmission, from within the partnership and from outside partners, and are a priority population for prevention interventions. Importantly, during the past year, both ART (HPTN 052) and PrEP (Partners PrEP Study) have demonstrated high efficacy for HIV-1 protection when used by members of HIV-1 serodiscordant couples. Critical unanswered questions for successful implementation of antiretroviral-based HIV-1 prevention include how to target these strategies to the highest-risk couples and whether HIV-1 infected persons with asymptomatic disease would accept ART to reduce their risk for transmitting HIV-1, at-risk HIV-1 negative persons would use PrEP, and both would sustain high adherence needed for high effectiveness. This protocol describes an open-label prospective study among high-risk African HIV-1 serodiscordant couples to determine user preferences for ART and PrEP and to optimize targeted delivery and sustained use of these interventions.</div>\n<div>\n </div>\n<div>\n Design: Prospective, observational, open-label cohort study</div>\n<div>\n Up to 24 months of follow-up per couple</div>\n<div>\n Population: Heterosexual HIV-1 serodiscordant couples in Kenya and Uganda who did not participate in the Partners PrEP Study (approximately 1000 couples in total)</div>\n<div>\n Study Sites: Thika, Kenya and Kampala, Uganda Partners PrEP Study sites</div>\n<div>\n Additional sites will be added if funding permits.</div>\n<div>\n Approach: We will enroll couples with characteristics defining higher HIV-1 transmission risk (i.e., to target those for ART/PrEP that are at greatest risk for HIV-1, a public health priority). We will provide or refer HIV-1 infected participants to ART services following national ART initiation guidelines, recognizing that guidelines for ART initiation (including potentially recommending ART for all HIV-1 infected members in serodiscordant relationships) may change during the course of the study. PrEP will be offered to the HIV-1 uninfected partners as a “bridge” to ART initiation and viral suppression in the partnership; uptake and adherence to PrEP will be measured. Specifically, PrEP as a bridge to ART will be done as follows: when the HIV-1 infected partner is not yet taking ART, PrEP will be offered, and if the HIV-1 infected partner initiates ART, PrEP will be discontinued for the HIV-1 uninfected partner six months later (i.e., once viral suppression in the HIV-1 infected partner would be expected to be typically achieved). We will conduct mixed-methods work to understand user preferences, couples decision-making, risk perception, fertility intentions, and barriers to uptake of and adherence to both PrEP and ART. </div>\n<div>\n </div>\n<div>\n Specific Aims:</div>\n<div>\n </div>\n<div>\n Aim 1: We will evaluate the ability to do targeted enrollment of higher-risk HIV-1 serodiscordant couples into a longitudinal HIV-1 prevention study</div>\n<div>\n </div>\n<div>\n A critical aspect of implementation and cost-effectiveness of antiretroviral-based HIV-1 prevention in HIV-1 serodiscordant couples will be the ability to utilize behavioral, epidemiologic and clinical data to identify those couples who are at highest risk of HIV-1 acquisition. We have developed a risk score using enrollment data from our previous studies of >8500 HIV-1 serodiscordant couples that is able to discriminate couples at highest risk. The score is comprised of a limited set of variables that can be obtained in research and clinical settings: plasma HIV-1 levels in the HIV-1 infected partner, any unprotected sex in the couple in the prior month, number of children in the partnership, age of the HIV-1 uninfected partner, and circumcision status of HIV-1 uninfected male partners.</div>\n<div>\n The primary outcomes of this aim will be the screened to eligible ratio of HIV-1 serodiscordant couples recruited for this open-label study, the proportion of eligible couples who decide to enroll in the cohort, and the costs of screening and targeting high-risk couples.</div>\n<div>\n </div>\n<div>\n Aim 2: We will assess user preferences among high-risk HIV-1 serodiscordant couples for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners.</div>\n<div>\n </div>\n<div>\n Understanding couples’ preferences for and concerns about antiretroviral-based HIV-1 prevention is of utmost importance at this time when guidelines for use of PrEP and ART are being formulated.</div>\n<div>\n The primary outcomes for this aim will be measured at baseline and quarterly through an interviewer-administered questionnaire. The questionnaire will specifically ask about willingness to use PrEP or ART for HIV-1 prevention and which method the participant would prefer. Reasons for the choice and concerns about both methods will also be collected through mixed-methods approaches.</div>\n<div>\n </div>\n<div>\n Aim 3: We will ascertain initiation of and adherence to PrEP among HIV-1 uninfected partners, when implemented as a bridge to ART.</div>\n<div>\n </div>\n<div>\n Adherence to PrEP is critical to its effectiveness. Understanding adherence to PrEP is a priority, particularly when PrEP is delivered outside of a controlled clinical trial setting. For this study, brief adherence counseling, to reflect real-world settings, will be delivered at baseline and then quarterly thereafter. The content of the adherence counseling will be derived from the counseling messages and procedures in the Partners PrEP Study, and informed by the findings from an ancillary adherence study conducted as part of the Partners PrEP Study. We will explore factors that are related to the decision to start and continue to use PrEP.</div>\n<div>\n The primary measures of adherence will be collection of PrEP, clinic-based pill counts of unused study pills as recorded at each follow-up visit, and MEMS cap data on how frequently the pill bottle was opened. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV-1 and a subset who remain HIV-1 uninfected.</div>\n<div>\n Aim 4: We will ascertain initiation of and adherence to ART among HIV-1 infected partners.</div>\n<div>\n </div>\n<div>\n In addition to providing clinical benefit to HIV-1 infected partners, ART also confers HIV-1 prevention benefits to HIV-1 uninfected partners. However, a substantial proportion of HIV-1 infected persons who are eligible for ART decline or delay initiation, for a number of reasons. In this study, HIV-1 infected partners who become eligible for ART will be actively encouraged to initiate, including counseling to improve their knowledge and understanding of ART and the benefits for themselves and their partner and the importance of strict adherence to ART regimens to achieve viral suppression. We will explore factors that are related to the decision to start and continue to use ART.</div>\n<div>\n The primary measures of ART adherence will be ART initiation at a local ART provider and plasma HIV-1 RNA levels taken every 6 months for HIV-1 infected partners.</div>\n<div>\n </div>\n<div>\n Aim 5: We will assess factors influencing preferences, uptake and adherence for antiretroviral-based HIV-1 prevention.</div>\n<div>\n </div>\n<div>\n Understanding factors that influence couples’ preferences and their likelihood to initiate and adherence to PrEP and/or ART in a real-world setting is critical for providers who will counsel HIV-1 serodiscordant couples and make</div>\n<div>\n Partners PrEP Study Demonstration Project 6 Version 2.0, 10 July 2012</div>\n<div>\n recommendations about the HIV-1 prevention practices that are best indicated for couples.</div>\n<div>\n Through interviewer-administered questionnaires, correlates of preferences, uptake and adherence to ART and PrEP will be assessed, including characteristics of sexual risk (i.e., sexual frequency, condom use, whether the HIV-1 uninfected partner reports outside partners), depression and substance use, gender of the HIV-1 uninfected partner, fertility intentions, partnership characteristics (whether the couple is cohabiting, has children, is together throughout follow-up, whether members have other partners, and whether the HIV-1 infected partner initiates ART), and clinical characteristics of the HIV-1 infected partner (e.g., CD4 count, WHO stage).</div>\n<div>\n Aim 6: We will assess the feasibility of PrEP discontinuation in couples in which the HIV-1 infected partner initiates ART</div>\n<div>\n </div>\n<div>\n ART is life-long, but PrEP need not be. In fact, time-limited use of PrEP for highest-risk persons and periods of time is likely the most cost-effective approach – since ART has substantial prevention benefits, any additional benefit of PrEP would be small for limiting risk within the partnership. Moreover, time-limited use of PrEP – e.g., until the HIV-1 infected partner initiates ART and is on ART for 6 months (the time by which viral suppression is typically achieved) – would limit risk of long-term side effects or toxicity of a daily PrEP medication and potentially improve adherence, since use would be for a defined period of time. Thus, time-limited use of PrEP has the greatest chance of being implemented widely. In couples in which the HIV-1 infected partner initiates ART, we will discontinue PrEP six months later. It is possible that HIV-1 uninfected partners may be reluctant to discontinue PrEP, for example if they do not trust their partner’s motivation to consistently use ART or if the uninfected partner has additional sexual partners. We will explore the ability to discontinue PrEP.</div>\n<div>\n Through interviewer-administered questionnaires, we will assess couples’ attitudes and understanding of PrEP discontinuation.</div>\n
 study_title\n An open-label, pilot demonstration and evaluation project of antiretrovira-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples.\n
 laymans_summary(null)
 short_titlePartners Demonstration Project
 protocol_noECCT/12/08/01
 version_no2.0
 date_of_protocol10-07-2012
 study_drugEmtricitabine 200mg/Tenofovir 300mg
 disease_conditionHIV-1 Prevention
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameEmtricitabine 200mg/Tenofovir 300mg (TruvadaÂ®)
 product_type_medical_device_name
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 ecct_not_applicable0
 ecct_ref_number
 email_addressRwamba@csrtkenya.org
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter1
 applicant_statement1
 applicant_participating_countries0
 applicant_addendum0
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd(null)
 applicant_prev_data(null)
 applicant_stability_data(null)
 applicant_analysis_cert(null)
 applicant_pictorial_sample(null)
 applicant_gcp_training(null)
 applicant_dsmb_charter(null)
 applicant_detailed_budget(null)
 applicant_indemnity_pi(null)
 applicant_practice_license(null)
 applicant_registration_ctr(null)
 applicant_pan_african(null)
 applicant_hard_copies(null)
 applicant_signed_checklist(null)
 statistical_analysis_plan(null)
 applicant_contractual_agreement(null)
 declaration_applicantDr. Kenneth Ngure
 declaration_date119-09-2013
 declaration_principal_investigatorDr. Nelly R.Mugo
 declaration_date219-09-2013
 placebo_presentNo
 study_objectives(null)
 principal_inclusion_criteria\n For Couples:\n<ul>\n <li>\n Risk score defining higher HIV-1 risk</li>\n <li>\n Sexually active (defined as havind had vaginal intercourse at least 6 times in the previous three months)</li>\n <li>\n Willing to enter the study as a couple and intending to remain as a couple for the next 12 months.</li>\n</ul>\n\n For HIV-1 Uninfected members of the couple (Partner participants)\n<ul>\n <li>\n Age ≥ 18</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 Uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit</li>\n <li>\n Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥ 60 ml/min</li>\n</ul>\n\n For HIV-1 Infected members of the couple (Index participants)\n<ul>\n <li>\n Age ≥ 18</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 Infected based on positive rapid HIV-1 tests, according to national algorithm</li>\n</ul>\n\n Note: Current pregnancy and breastfeeding are premitted for HIV-1 infected partners.\n
 principal_exclusion_criteria\n For couples:\n<ul>\n <li>\n Participated in the Partners PrEP Study</li>\n</ul>\n\n For HIV-1 Uninfected members of the couple (partner participants)\n<ul>\n <li>\n Infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test .</li>\n <li>\n currently pregnant or breastfeeding</li>\n <li>\n cureently enrolled in an HIV-1 prevention clinical trial</li>\n <li>\n currently using PrPEP</li>\n <li>\n Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator.</li>\n</ul>\n\n For HIV-1 infected members of the couple (Index participants)\n<ul>\n <li>\n History of WHO stage 3 or 4 conditions</li>\n <li>\n currently on ART</li>\n <li>\n Currently enrolled in an HIV-1 treatment study</li>\n</ul>\n
 primary_end_points<ol>\n <li>\n We will evaluate the ability to do targeted enrollment of higher-risk HIV-1 serodiscordant couples into a longitudinal HIV-1 prevention study</li>\n</ol>\n\n The primary outcomes of this aim will be the screened to eligible ratio of HIV-1 serodiscordant couples recruited for this open-label study, the proportion of eligible couples who decide to enroll in the cohort, and the costs of screening and targeting high-risk couples.\n<ol start=\"2\">\n <li>\n We will assess user preferences among high-risk HIV-1 serodiscordant couples for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners.</li>\n</ol>\n\n The primary outcomes for this aim will be measured at baseline and quarterly through an interviewer-administered questionnaire. The questionnaire will specifically ask about willingness to use PrEP or ART for HIV-1 prevention and which method the participant would prefer. Reasons for the choice and concerns about both methods will also be collected through mixed-methods approaches.\n<ol start=\"3\">\n <li>\n We will ascertain initiation of and adherence to PrEP among HIV-1 uninfected partners, when implemented as a bridge to ART.</li>\n</ol>\n\n The primary measures of adherence will be collection of PrEP, clinic-based pill counts of unused study pills as recorded at each follow-up visit, and MEMS cap data on how frequently the pill bottle was opened. Blood samples for detection and quantification of PrEP levels (testing in batch) will be done for those who seroconvert to HIV-1 and a subset who remain HIV-1 uninfected.\n<ol start=\"4\">\n <li>\n We will ascertain initiation of and adherence to ART among HIV-1 infected partners.</li>\n</ol>\n\n The primary measures of ART adherence will be ART initiation at a local ART provider and plasma HIV-1 RNA levels taken every 6 months for HIV-1 infected partners.\n<ol start=\"5\">\n <li>\n We will assess factors influencing preferences, uptake and adherence for antiretroviral-based HIV-1 prevention.</li>\n</ol>\n\n Through interviewer-administered questionnaires, correlates of preferences, uptake and adherence to ART and PrEP will be assessed, including characteristics of sexual risk (i.e., sexual frequency, condom use, whether the HIV-1 uninfected partner reports outside partners), depression and substance use, gender of the HIV-1 uninfected partner, fertility intentions, partnership characteristics (whether the couple is cohabiting, has children, is together throughout follow-up, whether members have other partners, and whether the HIV-1 infected partner initiates ART), and clinical characteristics of the HIV-1 infected partner (e.g., CD4 count, WHO stage).\n<ol start=\"6\">\n <li>\n We will assess the feasibility of PrEP discontinuation in couples in which the HIV-1 infected partner initiates ART</li>\n</ol>\n\n Through interviewer-administered questionnaires, we will assess couples’ attitudes and understanding of PrEP discontinuation.\n
 scope_diagnosis0
 scope_prophylaxis1
 scope_therapy1
 scope_safety1
 scope_efficacy0
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others1
 scope_others_specifyEffectiveness of TruvadaÂ® for HIV prevention in real world settings
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other1
 trial_other_specifyOpen label pilot demonstration and evaluation project
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory0
 trial_therapeutic_use1
 design_controlledNo
 site_capacity(null)
 staff_numbers\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).\n\n Principal Investigator: Dr. Nelly R. Mugo MBCHB,MMED,MPH\n\n Study coordinator: Dr. Kenneth Ngure BSc,MPH,MSc,PhD\n\n Lead Physician: Dr. Elizabeth Irungu MBCHB, MPH\n
 other_details_explanation\n Although the HIV-1 epidemic affects many populations in Africa (commercial sex workers, high-risk men employed far from their stable homes, young sexually active individuals), majority of HIV-1 transmissions to adults in Africa occur within stable, heterosexual, HIV-1 discordant couples. HIV-1 uninfected individuals within HIV-1 discordant partnerships are at high risk for HIV acquisition. HIV-1 discordant couples face unique challenges, including concerns over disclosure of HIV-1 status, HIV-1 associated stigma, and fear of domestic violence. In particular, issues regarding conception are especially concerning to HIV-1 discordant couples. Pregnancy rates in Africa are high (commonly 15-20 per 100 person-years), and social and familial pressures to seek pregnancy are strong, making HIV-1 transmission risk especially great for HIV-1 discordant couples, especially interventions that might allow pregnancy to occur safely, are urgently needed.\n\n In the absence of an HIV-1 cure and recognizing the long development timelines for microbicides and vaccines (that might have substantial impacts on the epidemic but are generally agreed to be over a decade away), other prevention strategies must be developed. \n\n Pre-exposure chemoprophylaxis, or PrEP, in which an HIV-1 uninfected individual at high risk for contracting HIV-1 takes antiretroviral medications to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been proposed as a novel potential HIV-1 prevention strategy. Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) has shown to be safe and effective medications to serve as PrEP. FTC/TDF is licenced , and had its label changed by FDA, for the treatment and prevention of HIV-1 infection. Truvada is potent , has long half-life (allowing once daily dosing) , achieve high concentrations in genital tract secretions, have high thresholds against development of viral resistance, do not interact with commonly used medications (e.g. hormonal contraceptives , anti tuberculsis medications), and has shown to be safe and well tolerated when used in HIV-1 prevention. \n
 other_details_regulatory_notapproved\n None Pending\n
 other_details_regulatory_approved\n 1.KNH/UON-ERC Approved 2 sites in Kenya (Thika and Kisumu)\n\n 2.University of Washington IRB, approved 2 sites in Kenya (Thika and Kisumu)\n
 other_details_regulatory_rejected\n NONE\n
 other_details_regulatory_halted
 estimated_duration24 Months
 design_controlled_randomised
 design_controlled_open
 design_controlled_single_blind
 design_controlled_double_blind
 design_controlled_parallel_group
 design_controlled_cross_over
 design_controlled_other
 design_controlled_specify
 design_controlled_comparator
 design_controlled_other_medicinal
 design_controlled_placebo
 design_controlled_medicinal_other
 design_controlled_medicinal_specify
 single_site_member_stateNo
 location_of_area
 single_site_physical_address
 single_site_contact_person
 single_site_telephone
 multiple_sites_member_stateYes
 multiple_countriesYes
 multiple_member_states2
 number_of_sites2
 multi_country_listKenya\nUganda
 data_monitoring_committeeNo
 total_enrolment_per_site500
 total_participants_worldwide1000
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male1
 subjects_healthyYes
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingYes
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenYes
 subjects_nursing_womenYes
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersYes
 subjects_others_specifyHIV infected partners in HIV-1 discordant relationships
 investigator1_given_nameDr. Jared
 investigator1_middle_nameMurray
 investigator1_family_nameBaeten
 investigator1_qualificationMD,PhD
 investigator1_professional_addressUniversity of Washington, Box 359927; 325 Ninth Avenue, Seattle Washington 98104
 investigator1_telephone206 520 3808
 investigator1_emailjbaeten@uw.edu
 organisations_transferred_Yes
 number_participants500
 notification
 approval_date01-10-2012
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted11-08-2013
 is_child0
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
 admin_stopped_reason(null)
 approved2
 approved_reason
 final_report(null)
 implication_results(null)
 quantity_imported(null)
 quantity_dispensed(null)
 quantity_destroyed(null)
 quantity_exported(null)
 balance_site(null)
 final_date(null)
 modified2018-08-28 16:19:41
 created2013-09-19 16:16:00
 total_sites(null)
 ecitizen_invoice(null)
 InvestigatorContact(array)
 0(array)
 id148
 application_id215
 given_nameDr. Nelly
 middle_nameRwamba
 family_nameMugo
 qualificationMBCHB, MMED, MPH
 professional_address 19865-00202
 telephone 067-22561, 0723914057
 emailRwamba@csrtkenya.org
 created2013-09-19 16:27:59
 modified2013-09-20 11:56:55
 SiteDetail(array)
 0(array)
 id183
 application_id215
 county_id22
 site_namePartners in Prevention, Thika Site
 physical_addressOAU Road, Near Thika Nursing Home
 contact_detailsP.O Box 19865-00202
 contact_personDr. Kenneth Ngure
 site_capacity(null)
 misc(null)
 created2013-09-19 16:27:59
 modified2013-09-20 11:56:55
 County(array)
 id22
 county_nameKiambu
 created2012-06-15 10:24:37
 modified2012-06-15 10:24:37
 1(array)
 id184
 application_id215
 county_id42
 site_namePartners in Prevention, Kisumu Site
 physical_addressAgoi Street
 contact_detailsP.O Box 614-40100
 contact_personJosephine B. Odoyo
 site_capacity(null)
 misc(null)
 created2013-09-19 17:11:17
 modified2013-09-20 11:56:55
 County(array)
 id42
 county_nameKisumu
 created2012-06-15 10:27:02
 modified2012-06-15 10:27:02
 Sponsor(array)
 0(array)
 id116
 application_id215
 sponsorUniversity of Washington
 sponsor_type(null)
 contact_personDr. Nelly R. Mugo
 addressP.O Box 19865-00202
 telephone_number06722561
 fax_numberN/A
 cell_number0733629665
 email_addressRwamba@csrtkenya.org
 created2013-09-19 16:27:59
 modified2013-09-20 11:56:55
 3(array)
 Application(array)
 id213
 user_id77
 trial_status_id5
 abstract_of_study\n Background: Adherence to HIV prevention and contraception technologies is imperfect but is key to effectiveness. The options currently available to protect women from HIV infection and unwanted pregnancy (e. g. condom use, abstinence, monogamy) are not consistently available, practical, or under women’s control. Intravaginal rings (IVRs) are an important technology that can be long-acting and woman-controlled and are being developed for HIV prevention with and without co-formulated hormonal contraception. Availability of IVRs in sub-Saharan Africa is limited; hence, it is important to evaluate acceptability, utilization, and biologic effects of IVR usage among African women. The NuvaRing® intravaginal combined hormonal contraceptive ring is used successfully in 61 countries worldwide, although not currently in Kenya. NuvaRing is self-inserted for 21 days starting after the last day of menses then removed for seven days to allow menses to occur, and has comparable effectiveness to oral contraceptives. In preparation for a potential future Phase 2 trial of a combination antiretroviral-contraceptive IVR, KEMRI/CDC proposes to examine adherence, acceptability and biological effects of NuvaRing® among contracepting Kenyan women.\n\n \n\n Objectives:\n<ol>\n <li>\n To assess adherence and utilization patterns for NuvaRing®, behaviourally and biologically.</li>\n <li>\n To assess acceptability and effect of NuvaRing® on sexual behaviour among women and their sexual partners in a setting where there is no routine IVR use. At the end of the NuvaRing® trial, to additionally assess the hypothetical acceptability of a prototype dual use HIV-prevention and contraceptive IVR among women who had used NuvaRing® and among women who have never used an IVR.</li>\n <li>\n To assess biologic effects of NuvaRing® including standard safety monitoring and, among a subset of participants, genital compartment immunology and microbiology.</li>\n</ol>\n\n Study Subjects: A total of 220 women and 20 men will be enrolled in different parts of the proposed study. The primary NuvaRing® trial participants (Objectives 1 and 2 above) will be up to 200 young, healthy women recruited from family planning clinics in the Kisumu catchment area. Fifty of these will form a biomedical subgroup addressing Objective 3. To augment Objective 2, twenty trial participants and their sexual partners will take part in a qualitative in-depth interview, and three focus group discussions will be conducted, one with study participants and the others with 20 women who were not part of the primary NuvaRing® trial. \n\n \n\n Design: Single arm clinical trial with up to 3 month pre-product phase (on oral or injectable contraceptives) followed by 6 months of IVR use, ending with an up to 3 month post-product phase during which women return to oral or injectable contraceptives and then exit study. Monthly and quarterly follow-up will include adherence, acceptability and clinical assessments, HIV and pregnancy testing. Women in biomedical subgroup will undergo more frequent visits and collection of genital specimens. In-depth interview and focus group discussions are delineated under ‘Study Subjects’ above.\n\n \n\n Outcome: The study will improve understanding of adherence to biomedical technologies, facilitate the conduct of future HIV microbicide clinical trials relying on IVR technology, and inform public health practice regarding contraception. \n
 study_title\n Clinical Trial of Acceptability, Adherence and Biologic Effects of a Vaginal Contraceptive Ring among Women in Western Kenya\n
 laymans_summary(null)
 short_title(null)
 protocol_noECCT/13/10/01
 version_no3
 date_of_protocol18-09-2013
 study_drugEthinylestradiol/Etonogestrel
 disease_conditionContraception
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameEthinylestradiol/Etonogestrel
 product_type_medical_device_name
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 ecct_not_applicable0
 ecct_ref_number
 email_addresseayuo@kemricdc.org
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter0
 applicant_statement1
 applicant_participating_countries0
 applicant_addendum0
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd(null)
 applicant_prev_data(null)
 applicant_stability_data(null)
 applicant_analysis_cert(null)
 applicant_pictorial_sample(null)
 applicant_gcp_training(null)
 applicant_dsmb_charter(null)
 applicant_detailed_budget(null)
 applicant_indemnity_pi(null)
 applicant_practice_license(null)
 applicant_registration_ctr(null)
 applicant_pan_african(null)
 applicant_hard_copies(null)
 applicant_signed_checklist(null)
 statistical_analysis_plan(null)
 applicant_contractual_agreement(null)
 declaration_applicantFredrick O. Otieno
 declaration_date111-09-2013
 declaration_principal_investigatorFredrick Otieno
 declaration_date211-09-2013
 placebo_presentNo
 study_objectives(null)
 principal_inclusion_criteria\n To be included in the NuvaRing® trial (excluding the FGD participants drawn from outside the trial population), participants will need to meet the following criteria:\n\n · 18 to 34 years of age – Age will be verified using a standard national document e.g. Identity card, birth notification e.t.c. and in case they are missing we will rely on proxy verification\n\n · Fluent in English, Swahili, or DhoLuo\n\n · Resident of the Kisumu catchment area (≈150 kilometres from Kisumu City)\n\n · Able and willing to provide written informed consent\n\n · Willing to provide detailed locator information and not planning to relocate outside the study area for next 12 months\n\n · Engaged in more than one episode of vaginal intercourse on different days in the past 30 days\n\n · Female, not currently pregnant and not intending to get pregnant for the next 12 months\n\n · Demonstrated willingness to prevent conception for the next 12 months, based on:\n\n o Documented receipt of three on-time monthly refills of OCPs, or one DMPA injection at a FP clinic in the last 3 months prior to enrolling in the study.\n\n · Willing to exclusively use IVR for contraception for the duration of the intervention phase of study. (Proper and consistent condom use will be encouraged and condoms will be provided for STI/HIV prevention)\n\n · HIV negative per Kenya’s HIV testing algorithm (using rapid tests)\n\n · Willing to undergo periodic study procedures including pregnancy testing, HIV and STI testing \n
 principal_exclusion_criteria\n Participants will be excluded from the study based on:\n\n · Known medical contraindications:\n\n · Thrombophlebitis or thromboembolic disorders (current or history)\n\n · Cerebral vascular or coronary artery disease (current or history)\n\n · Valvular heart disease with thrombogenic complications\n\n · Severe hypertension\n\n · Diabetes with vascular involvement\n\n · Headaches with focal neurological symptoms\n\n · Major surgery with prolonged immobilization\n\n · Known or suspected carcinoma of the breast or personal history of breast cancer\n\n · Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia\n\n · Undiagnosed abnormal genital bleeding\n\n · Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use\n\n · Hepatic tumors (benign or malignant) or active liver disease\n\n · Known or suspected pregnancy\n\n · Heavy smoking (≥15 cigarettes per day) and over age 35\n\n · Hypersensitivity to any of the components of NuvaRing®\n\n · Current breastfeeding or being within three months of parturition, at the time of screening.\n\n Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, reproductive, or allergic disease that would compromise the ability of the participant to provide informed consent, or to complete study procedures or study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study. \n
 primary_end_points\n Pregnancy at any of the three phases\n
 scope_diagnosis0
 scope_prophylaxis0
 scope_therapy0
 scope_safety1
 scope_efficacy1
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others1
 scope_others_specifyAcceptability and Adherence Evaluation
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory0
 trial_therapeutic_confirmatory0
 trial_therapeutic_use1
 design_controlledYes
 site_capacity(null)
 staff_numbers\n The study has employed the following cadre of staff: Study coordinator (1), Data manager (1), Programmer (1), Data analyst (1), Medical records technologist (2), Administrative assistants (2), Administrative officers (1), Regulatory officer (1), quality control officer (1), behavioural scientist (1), nurse counsellors (2), laboratory technologists (2), pharmaceutical technologist (1) and community intervoewers (5).<a>· The key study staff are as indicated below: </a>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:633px;\" width=\"633\">\n <tbody>\n <tr>\n <td style=\"width:132px;\">\n \n Fredrick O. Otieno\n </td>\n <td style=\"width:208px;\">\n \n KEMRI Principal Investigator,\n \n Research Officer,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n DipClinMed, MPH\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n Tereza A. Omoro\n </td>\n <td style=\"width:208px;\">\n \n Investigator,\n \n Community Technician,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n DipCommunity\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n Arthur O. Ogendo\n </td>\n <td style=\"width:208px;\">\n \n Investigator,\n \n Research Officer,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n BA Sociology\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n Kenneth Ondeng’e\n </td>\n <td style=\"width:208px;\">\n \n Investigator,\n \n Assistant Research Officer,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n BA Sociology, MA\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n Beatrice A. Nyagol\n </td>\n <td style=\"width:208px;\">\n \n Clinician,\n \n HIV Research Branch, \n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n DipClinMed\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n Victor Mudhune\n </td>\n <td style=\"width:208px;\">\n \n Pharmacist,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n B.Pharm\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n \n George Olilo\n </td>\n <td style=\"width:208px;\">\n \n Senior Data Manager,\n \n HIV Research Branch,\n \n KEMRI/CDC, Kisumu\n </td>\n <td style=\"width:293px;\">\n \n BSc (Stat), Msc\n </td>\n </tr>\n </tbody>\n</table>\n\n The study clinic is complete with 6 clinic room, pharmacy, 2 counselling rooms and computer ACASI room. Within the compound there is an ISO certified laboratory for clinical investogations. The clinic is located within the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), which provide clinical support if and when needed. \n
 other_details_explanation\n The Nuvaring (Ethinylestradiol/Etonogestrel) product is approved for market in the US after successive trials in country.The key objective of this study is to look at acceptability of vaginal inserts in the local population, and address underlying adherence concerns in the local (Kenyan) population. \n
 other_details_regulatory_notapproved\n None\n
 other_details_regulatory_approved\n KEMRI on 27th September 2013 (1 site in country)\n
 other_details_regulatory_rejected\n None\n
 other_details_regulatory_halted\n Not applicable\n
 estimated_duration18 months including enrollment period
 design_controlled_randomisedNo
 design_controlled_openNo
 design_controlled_single_blindNo
 design_controlled_double_blindNo
 design_controlled_parallel_groupNo
 design_controlled_cross_overYes
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorDepot Medroxyprogesterone
 design_controlled_other_medicinalNo
 design_controlled_placeboNo
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateYes
 location_of_areaKEMRI/CDC Research and Public Health Collaboration
 single_site_physical_addressP. O. Box 1578-40100, Kisumu
 single_site_contact_personFredrick O. Otieno
 single_site_telephone+254572022929
 multiple_sites_member_stateNo
 multiple_countriesNo
 multiple_member_states
 number_of_sites
 multi_country_list
 data_monitoring_committeeNo
 total_enrolment_per_site220
 total_participants_worldwide220
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyNo
 gender_female1
 gender_male0
 subjects_healthyYes
 subjects_patientsNo
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingYes
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameFredrick
 investigator1_middle_nameOdhiambo
 investigator1_family_nameOtieno
 investigator1_qualificationDipClinMed, MPH
 investigator1_professional_addressP.O. Box 1578-40100 Kisumu.
 investigator1_telephone+254572022929
 investigator1_emailFOtieno@Kemricdc.org
 organisations_transferred_No
 number_participants220
 notification\n None\n
 approval_date27-09-2013
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted10-10-2013
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 modified2016-05-23 09:44:21
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 given_nameFredrick
 middle_nameOdhiambo
 family_nameOtieno
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 professional_addressP.O. Box 1578-40100 Kisumu.
 telephone+254572022929
 emailFOtieno@Kemricdc.org
 created2013-09-11 11:50:20
 modified2013-10-10 12:11:01
 1(array)
 id147
 application_id213
 given_nameLisa
 middle_nameAnn
 family_nameMills
 qualificationMD, MSc.
 professional_addressP.O. Box 1578-40100 Kisumu.
 telephone+254572022929
 emailLMILLS@KE.CDC.GOV
 created2013-09-11 12:07:59
 modified2013-10-10 12:11:01
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 0(array)
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 sponsorDivision of HIV/AIDS Prevention, U. S. Centers for Disease Control and Prevention
 sponsor_type(null)
 contact_personTaraz Samandari
 address1600 Clifton Rd, Mailstop E-45. Atlanta, GA 30333. U. S. A.
 telephone_number(404) 639-5173
 fax_number
 cell_number(404) 639-5173
 email_addresstts0@cdc.gov
 created2013-09-11 11:50:20
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 abstract_of_study\n AIDS-Related Non-Hodgkin’s Lymphoma (AR-NHL)\n\n Approximately 10% of the world population lives in sub-Saharan Africa, but the region is home to approximately 68% of the world population living with HIV1. Most countries in this region have an HIV prevalence of at least 10% with a number of countries having a prevalence that exceeds 20%2. As the AIDS pandemic advances, the burden of related neoplastic disease is increasing in developing nations3,4. While under-developed cancer registries in sub-Saharan Africa bar a definitive statement being made regarding increases in incidence and prevalence in Africa, it is felt that AIDS-Related Non-Hodgkin’s Lymphoma\n\n (AR-NHL) has rising incidence in this setting. Investigators involved in this study have previously published data that outcomes of AR-NHL are worse than NHL in seronegative patients5. Unfortunately, building on this observation is difficult, as there have been few published data on the tolerance and outcomes of treatment for HIV-associated non-Hodgkin lymphoma (NHL) in sub-Saharan Africa or on the most effective treatment regimen(s) in the varied clinical settings that exist within the region. Although all of the AMC African trial\n\n sites cite CHOP as a “standard of care” for initial treatment of HIV-associated NHL, only one, the Uganda Cancer institute (UCI), has published information on treatment outcomes.\n\n \n\n \n\n \n\n The most comprehensive accounting of newly diagnosed NHL, from the UCI and recently published by Bateganya et al6, remains limited; between 2004 and 2008 only 51 HIV-infected patients were identified. Although CHOP chemotherapy was administered to approximately two-thirds of all patients, the estimated median survival, even among HIV-seronegative individuals, was less than 1 year and the authors found no evidence that receipt of chemotherapy improved survival. HIV-positive patients receiving antiretroviral therapy had survival rates approximating those of HIV-negative persons, but the adjusted hazard of death was significantly elevated among HIV-positive patients not receiving antiretroviral therapy [adjusted hazard ratio (HR) 8.99, P < 0.001] compared with HIV-negative patients. An updated and as yet unpublished analysis (P. Imani and C. Casper, Personal Communication, January 2012) showed that of the 37 HIV+ patients in this study who received CHOP\n\n chemotherapy, 34 received at least 70% of the standard dose. However, only 4 of 34 patients received at least 6 cycles of chemotherapy. The estimated median survival for all HIV+ patients who received CHOP was approximately 6 months, and only one patient was known\n\n to be alive at 2 years. Interpreting the reason for the poor outcome for both HIV-infected and HIV-uninfected individuals is complicated by a high loss to follow-up rate and lack of information on therapy-related complications and causes of death7, not to mention issues\n\n related to the purity and potency of locally-sourced chemotherapeutic agents.\n\n \n\n \n
 study_title\n A Randomized Phase II Trial Of Chop Vs Oral Chemotherapy with Concomitant Antiretroviral Therapy in Patients with HIV-Associated Lymphoma in Sub-Saharan Africa\n
 laymans_summary\n AMC-068 is a randomized phase II multi-center clinical trial which compares of intravenous versus oral chemotherapy for HIV-positive individuals with diffuse large B-cell lymphoma. A total of 90 participants are expected to be enrolled with 45 particpants enrolled in each arm.\n\n The purpose of this study is to see if a mixture of anti-cancer medicines given by mouth is as good as a mixture of anti-cancer medicines given by vein for treating Africans with AIDS and NHL. This study will help develop better treatments for people with AIDS and cancer in Africa.\n\n \n
 short_titleAMC 068
 protocol_noECCT/13/02/01
 version_no3.0
 date_of_protocol03-08-2012
 study_drugLomustine, Etoposide, Cyclophosphamide, Procarbazine
 disease_conditionAIDS ASSOCIATED NON HODGKINS LYMPHOMA
 product_type_biologicals0
 product_type_proteins0
 product_type_immunologicals0
 product_type_vaccines0
 product_type_hormones0
 product_type_toxoid0
 product_type_chemical1
 product_type_medical_device0
 product_type_chemical_nameLomustine, Etoposide, Cyclophosphamide, Procarbazine
 product_type_medical_device_name
 comparator(null)
 comparator_name(null)
 comparator_registered(null)
 comparator_countries(null)
 ecct_not_applicable0
 ecct_ref_number
 email_addressamckenya@yahoo.com
 applicant_covering_letter1
 applicant_protocol1
 applicant_patient_information1
 applicant_investigators_brochure1
 applicant_investigators_cv1
 applicant_signed_declaration1
 applicant_financial_declaration1
 applicant_gmp_certificate1
 applicant_indemnity_cover1
 applicant_opinion_letter1
 applicant_approval_letter0
 applicant_statement1
 applicant_participating_countries0
 applicant_addendum0
 applicant_fees1
 applicant_complete_form(null)
 applicant_impd(null)
 applicant_prev_data(null)
 applicant_stability_data(null)
 applicant_analysis_cert(null)
 applicant_pictorial_sample(null)
 applicant_gcp_training(null)
 applicant_dsmb_charter(null)
 applicant_detailed_budget(null)
 applicant_indemnity_pi(null)
 applicant_practice_license(null)
 applicant_registration_ctr(null)
 applicant_pan_african(null)
 applicant_hard_copies(null)
 applicant_signed_checklist(null)
 statistical_analysis_plan(null)
 applicant_contractual_agreement(null)
 declaration_applicantDR. EVANGELINE NJIRU
 declaration_date127-08-2013
 declaration_principal_investigatorDR. NAFTALI BUSAKHALA
 declaration_date227-08-2013
 placebo_presentNo
 study_objectives(null)
 principal_inclusion_criteria<div>\n \n Inclusion criteria\n <ol>\n <li style=\"margin-left: 41.95pt;\">\n Â Ability to understand and the willingness to provide informed consent to participate.</li>\n <li style=\"margin-left: 41.95pt;\">\n Â Adults, 18 years of age or older. Date of birth and age should be determined based on the best possible information or source documentation available.</li>\n <li style=\"margin-left: 41.95pt;\">\n Â HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 RNA viral load > 1,000 copies/mL</li>\n <li style=\"margin-left: 41.95pt;\">\n Biopsy-proven, measurable or assessable systemic NHL that has been confirmed by an AMC- approved site pathologist. If a hard copy of the pathology report is unavailable at the time of enrolment, a verbal report by the pathologist confirming the diagnosis must be documented in the medical chart.</li>\n <li style=\"margin-left: 41.95pt;\">\n Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry. Confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry. Please reference the AMC-068 MOP for further instructions on documenting the diagnosis</li>\n <li style=\"margin-left: 41.95pt;\">\n Participants must have fifteen blank (unstained) slides or a diagnostic tissue block must be available for central pathology review by the AMC Core Pathology Laboratory</li>\n <li style=\"margin-left: 41.95pt;\">\n ECOG performance status of 0 - 3 within 7 days of enrolment</li>\n <li style=\"margin-left: 41.95pt;\">\n Participants must have an estimated life expectancy of > 6 weeks.</li>\n <li style=\"margin-left: 41.95pt;\">\n The following acceptable end organ function/laboratory parameters within 7 days prior to enrollment.</li>\n <li style=\"margin-left: 41.95pt;\">\n Hematologic (Participants may enroll with lower hematologic values, if bone marrow involvement is documented. In this case, patients should be transfused to hemoglobin > 8 g/dL):</li>\n </ol>\n <ul>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n WBC â‰¥ 3,000 cells/ïL (3.0 x 109 L) or absolute granulocytes â‰¥ 1500 cells/Î¼L</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n (1.5 x 109 L); and</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Platelets â‰¥ 100,000 cells/Î¼L (75 x 10 9 L)</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Â Hemoglobin > 8 g/dL (5.0 mmol/)</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Renal â€“ serum creatinine < 3.0 mg/dL (265.2 Âµmol/L); and</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Hepatic: Total bilirubin â‰¤ 1.5 institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir). If secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 Î¼M/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 Î¼M/L).</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n AST/ALT < 2.5 institutional ULN (unless elevated secondary to lymphomatous involvement of the liver)</li>\n </ul>\n \n Â \n \n 10. Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 6 weeks prior to enrollment. Participants must be without evidence for CNS lymphoma on neurological exam and have no radiographic evidence (if radiographic studies are done) of CNS lymphoma (inclusive of parenchymal, vitreal, or leptomeningeal involvement).\n \n 11. Participants must not have had any prior chemotherapy or radiation therapy and no more than 10 days of corticosteroids in the preceding 30 days prior to enrolment.\n \n 12. All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection. Non-suppressed, treatment experienced patients, defined as patients with a viral load >\n \n 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative ART regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history. Patients are not allowed to receive zidovudine (AZT) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive. Zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment.\n \n 13. Participants of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception (e.g.,barrier contraception, highly effective hormonal contraception)\n \n Â Â Â Â Â Â Â 14. Participants are allowed to have an active infection(s) for which they are receiving drug treatment provided the clinical status is judged to be stable andÂ Â Â survival is estimated to be at least 6 weeks.\n \n Â Â Â Â Â Â Â 15. Participants must, in the opinion of the investigator, be capable of complying with the protocol.\n \n Â Â Â Â Â Â Â 16. Participants must be able to take oral medications\n \n Â Â Â Â Â Â Â Â Â 17. Participants must have a CD4 count performed within 30 days of enrollment\n</div>\n\n Â \n
 principal_exclusion_criteria<ol>\n <li style=\"margin-left: 21.05pt;\">\n Inability to provide informed consent.</li>\n <li style=\"margin-left: 21.05pt;\">\n A medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations</li>\n <li style=\"margin-left: 21.05pt;\">\n Participants with circumstances that will not permit completion of the study or required follow-up. For instance, if travel to and from treatment site is an issue</li>\n <li style=\"margin-left: 21.05pt;\">\n Pregnant or breastfeeding</li>\n <li style=\"margin-left: 21.05pt;\">\n nability to swallow oral medications</li>\n</ol>\n
 primary_end_points\n To compare the efficacy of standard CHOP and an oral chemotherapy regimen for AR-NHL in Sub-Saharan\n\n Africa with respect to overall survival (OS).\n
 scope_diagnosis1
 scope_prophylaxis1
 scope_therapy1
 scope_safety1
 scope_efficacy1
 scope_pharmacokinetic0
 scope_pharmacodynamic0
 scope_bioequivalence0
 scope_dose_response0
 scope_pharmacogenetic0
 scope_pharmacogenomic0
 scope_pharmacoecomomic0
 scope_others0
 scope_others_specify
 trial_human_pharmacology0
 trial_administration_humans0
 trial_bioequivalence_study0
 trial_other0
 trial_other_specify
 trial_therapeutic_exploratory1
 trial_therapeutic_confirmatory0
 trial_therapeutic_use0
 design_controlledYes
 site_capacity(null)
 staff_numbers\n Staff\n\n Â \n\n Naftali Busakhala MBChB, MMed, Principal Investigator\n\n Â \n\n Evangeline W. Njiru- MBChB, MMed- Investigator\n\n Â \n\n Paul Wasike, B Pharm, Pharmacist of Record\n\n Â \n\n Job Kisuya- Site Coordinator\n\n Â \n\n Grieven Otieno- Data Manager\n\n Â \n\n Medical Officer-Mildred Hagembe\n\n Â \n\n Clinical Officer-Enock Sumukwo\n\n Â \n\n Study Nurse- Peninah Biwott\n\n Â \n\n Study Nurse- Phyllis Bartilol\n\n Â \n\n Gilbert Koech, B Pharm- Back-up Pharmacist\n\n Â \n\n Fred Kiplagat, Dip Pharm- Back-up Pharmaceutical Technologist\n\n Â \n\n Site/Emergency Facilities:\n\n Â \n\n Â·Â Â Â AMPATH Programâ€“ Has 24 care sites and 34 satellite clinics in North Rift and Western\n\n Kenya\n\n Â·Â Â Â AMPATH Oncology Clinic-Has 1 care site and 4 satellite clinics in North Rift and\n\n Western\n\n Â·Â Â Â AMPATH Reference Laboratory and MTRH histopathology Laboratory\n\n Â·Â Â Â Moi Teaching and Referral Hospital (MTRH)- Second largest referral Hospital in Kenya.\n
 other_details_explanation\n Eldoret, Kenya is one of the Africa AMC sites. When protocols are developed by the AMC, sites express interests considering the patient population and relevance of the study. Our site expressed interest and was chosen as a participating site.\n\n Â \n
 other_details_regulatory_notapproved\n NONE\n
 other_details_regulatory_approved\n AUTHORITY: MOI UNIVERSITY INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE\n\n DATE OF APPROVAL : 22ND NOVEMBER 2012\n
 other_details_regulatory_rejected\n NONE\n
 other_details_regulatory_halted\n NONE\n
 estimated_duration72 months
 design_controlled_randomisedYes
 design_controlled_openNo
 design_controlled_single_blindNo
 design_controlled_double_blindNo
 design_controlled_parallel_groupNo
 design_controlled_cross_overNo
 design_controlled_otherNo
 design_controlled_specify
 design_controlled_comparatorCurrent Treatment by CHOP
 design_controlled_other_medicinalNo
 design_controlled_placeboNo
 design_controlled_medicinal_otherNo
 design_controlled_medicinal_specify
 single_site_member_stateYes
 location_of_areaMOI UNIVERSITY CLINICAL RESEARCH CENTER
 single_site_physical_addressAMPATH CENTER, NANDI ROAD
 single_site_contact_personDR. NAFTALI BUSAKHALA
 single_site_telephone0722496933
 multiple_sites_member_stateNo
 multiple_countriesYes
 multiple_member_states4
 number_of_sites
 multi_country_listKENYA: MOI UNIVERSITY CLINICAL RESEARCH CENTER\nUGANDA: UGANDA CANCER INSTITUTE\nZIMBABWE: UNIVERSITY OF ZIMBABWE\nSOUTH AFRICA: WITWATERSRAND UNIVERSITY
 data_monitoring_committeeYes
 total_enrolment_per_site90
 total_participants_worldwide360
 population_less_than_18_yearsNo
 population_uteroNo
 population_preterm_newbornNo
 population_newbornNo
 population_infant_and_toddlerNo
 population_childrenNo
 population_adolescentNo
 population_above_18Yes
 population_adultYes
 population_elderlyYes
 gender_female1
 gender_male1
 subjects_healthyNo
 subjects_patientsYes
 subjects_vulnerable_populationsYes
 subjects_women_child_bearingNo
 subjects_women_using_contraceptionYes
 subjects_pregnant_womenNo
 subjects_nursing_womenNo
 subjects_emergency_situationNo
 subjects_incapable_consentNo
 subjects_specify
 subjects_othersNo
 subjects_others_specify
 investigator1_given_nameEVANGELINE
 investigator1_middle_name
 investigator1_family_nameNJIRU
 investigator1_qualificationMBCHB, MMED
 investigator1_professional_address4606
 investigator1_telephone0722624353
 investigator1_emailoyungueva@yahoo.com
 organisations_transferred_No
 number_participants90
 notification
 approval_date22-11-2012
 submitted1
 deleted0
 deleted_date(null)
 deactivated0
 date_submitted27-08-2013
 is_child0
 unsubmitted0
 initial_date_submitted(null)
 admin_stopped0
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 approved2
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 final_report\n AMC-068 was a randomized phase II comparison of intravenous versus oral chemotherapy for HIV-positive diffuse large B-cell lymphoma. Opening in 2016, AMC-068 planned to enroll 90 patients (45 per arm) in Kenya, Malawi, Uganda, and Zimbabwe over 24 months and follow patients for 24 months to assess overall survival. In 2018, the study closed after screening 42 patients but enrolling only 7. Challenges occurred during protocol development, pre-activation, and post activation. During protocol development (2011-2012), major obstacles were limited baseline data to inform study design; lack of consensus among investigators and approving bodies regarding appropriateness of the oral regimen and need for randomized comparison with cyclophosphamide, doxorubicin, vincristine, and prednisone; and heterogeneity across sites in local standards for diagnosis, staging, and treatment. During pre-activation (2012-2016), challenges included unexpected length and layers of regulatory approval across multiple countries, need to upgrade pathology capacity at sites, need to augment existing chemotherapy infusion capacity at sites, and procurement issues for drugs and supplies. Finally, during post activation (2016-2018), challenges included long delays between symptom onset and screening entry for many patients, leading to compromised performance status and organ function; other patient characteristics that frequently led to exclusion, including high tumor proliferative index or other pathologic features that were disallowed; and costs of routine diagnostic procedures often being borne by patients, which also contributed to pre-enrollment delays.\n\n \n
 implication_results\n Lessons from AMC-068 are being applied to the design and conduct of new AMC lymphoma trials in SSA, and the study has contributed to a strong operational foundation that will support innovative clinical trials in the future. \n
 quantity_importedProcarbazine 50mg - 300, Prednisone 50mg - 1500, Lomustine - 160, Etoposide - 180, Cyclosphamide 60mg - 600, Clyclosphamide 500mg - 180, Doxorubicin 2mg/ml - 204 and Vincristine 1mg/ml - 166
 quantity_dispensedProcarbazine 50mg - 80, Prednisone 50mg - 60, Lomustine - 28, Etoposide - 60, Cyclosphamide 60mg - 100, Clyclosphamide 500mg - 13, Doxorubicin 2mg/ml - 7 and Vincristine 1mg/ml - 12
 quantity_destroyedProcarbazine 50mg - 220, Prednisone 50mg - 1440, Lomustine - 132, Etoposide - 120, Cyclosphamide 60mg - 500, Clyclosphamide 500mg - 167, Doxorubicin 2mg/ml - 197 and Vincristine 1mg/ml - 154
 quantity_exportedNot applicable
 balance_site0
 final_date0000-00-00
 modified2024-06-04 14:25:48
 created2013-08-22 15:41:41
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 qualificationMBCHB, MMED
 professional_address4606
 telephoneO722496933
 emailnbusakhala@yahoo.com
 created2013-08-27 16:32:38
 modified2013-08-27 18:25:49
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 created2013-08-27 16:32:38
 modified2013-08-27 18:25:49
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 id112
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 sponsorNational Cancer Institute Office of HIV and AIDS Malignancy (OHAM)
 sponsor_type(null)
 contact_person
 address31 Center Drive, Room 3A33 Bethesda, MD, USA 20852-2440
 telephone_number301-496-4995
 fax_number
 cell_number301-496-4995
 email_addressNCIOHAMContact@mail.nih.gov
 created2013-08-27 16:32:38
 modified2013-08-27 18:25:49
- page_options(array)
 55
 1010
- redir
- $request->data(array)
 Application(array)
 approved2
- $this->validationErrors(array)
 Permission(empty)
 Aro(empty)
 Aco(empty)
 Application(empty)
 User(empty)
 TrialStatus(empty)
 InvestigatorContact(empty)
 Sponsor(empty)
 SiteDetail(empty)
 County(empty)
- Loaded Helpers(array)
 0Html
 1Form
 2Session
 3Text
 4Number
 5SimpleGraph
 6Paginator
 7DebugTimer
 8Toolbar
 9HtmlToolbar
====

Environment

App Constants

Constant	Value
MEDIA	'/var/www/html/ctr/app/webroot/media/'
MEDIA_STATIC	'/var/www/html/ctr/app/webroot/media/static/'
MEDIA_FILTER	'/var/www/html/ctr/app/webroot/media/filter/'
MEDIA_TRANSFER	'/var/www/html/ctr/app/webroot/media/transfer/'
MEDIA_URL	'media/'
MEDIA_STATIC_URL	'media/static/'
MEDIA_FILTER_URL	'media/filter/'
MEDIA_TRANSFER_URL	'media/transfer/'
HTTP_HOST	'ctr.pharmacyboardkenya.org'
HTTP_BASE	'http://ctr.pharmacyboardkenya.org'
HTTP_SELF	'/app/webroot/index.php'
HTTP_URI	'/applications/index/page:90/approved:2'
CHOWN_PUBLIC	(int) 504
LF	''
NL	''
CR	''
TB	''
BR	' '
WINDOWS	false
FORMAT_DB_DATETIME	'Y-m-d H:i:s'
FORMAT_DB_DATE	'Y-m-d'
FORMAT_DB_TIME	'H:i:s'
DEFAULT_DATETIME	'0000-00-00 00:00:00'
DEFAULT_DATE	'0000-00-00'
DEFAULT_TIME	'00:00:00'
FILES	'/var/www/html/ctr/app/files/'
LOCALE	'/var/www/html/ctr/app/locale/'
CLASS_USER	'User'
VALID_ALPHA	'/^[a-zA-Z]+$/'
VALID_ALPHA_UNDERSCORES	'/^[a-zA-Z_]+$/'
VALID_ALPHA_MINUS_UNDERSCORES	'/^[a-zA-Z_-]+$/'
VALID_ALPHA_WHITESPACES	'/^[a-zA-Z ]+$/'
VALID_ALPHANUMERIC_UNDERSCORES	'/^[\da-zA-Z_]+$/'
VALID_ALPHANUMERIC_MINUS_UNDERSCORES	'/^[\da-zA-Z_-]+$/'
VALID_ALPHANUMERIC_WHITESPACES	'/^[\da-zA-Z ]+$/'
VALID_ALPHANUMERIC_WHITESPACES_UNDERSCORES	'/^[\da-zA-Z _]+$/'
VALID_NUMERIC_UNDERSCORES	'/^[\d_]+$/'
VALID_NUMERIC_WHITESPACES	'/^[\d ]+$/'
VALID_NUMERIC_WHITESPACES_UNDERSCORES	'/^[\d _]+$/'
VALID_INTEGERS	'/^[\d]+$/'
FORMAT_NICE_YMDHMS	'd.m.Y, H:i:s'
FORMAT_NICE_YMDHM	'd.m.Y, H:i'
FORMAT_NICE_YM	'm.Y'
FORMAT_NICE_YMD	'd.m.Y'
FORMAT_NICE_MD	'd.m.'
FORMAT_NICE_D	'd'
FORMAT_NICE_W_NUM	'w'
FORMAT_NICE_W_ABBR	'D'
FORMAT_NICE_W_FULL	'l'
FORMAT_NICE_M	'm'
FORMAT_NICE_M_ABBR	'M'
FORMAT_NICE_M_FULL	'F'
FORMAT_NICE_Y_ABBR	'y'
FORMAT_NICE_Y	'Y'
FORMAT_NICE_HM	'H:i'
FORMAT_NICE_HMS	'H:i:s'
FORMAT_LOCAL_WA_YMDHMS	'%a, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WF_YMDHMS	'%A, %d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_WA_YMDHM	'%a, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_WF_YMDHM	'%A, %d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMDHMS	'%d.%m.%Y, %H:%M:%S'
FORMAT_LOCAL_YMDHM	'%d.%m.%Y, %H:%M'
FORMAT_LOCAL_YMD	'%d.%m.%Y'
FORMAT_LOCAL_MD	'%d.%m.'
FORMAT_LOCAL_D	'%d'
FORMAT_LOCAL_W_NUM	'%w'
FORMAT_LOCAL_W_ABBR	'%a'
FORMAT_LOCAL_W_FULL	'%A'
FORMAT_LOCAL_M	'%m'
FORMAT_LOCAL_M_ABBR	'%b'
FORMAT_LOCAL_M_FULL	'%B'
FORMAT_LOCAL_Y_ABBR	'%y'
FORMAT_LOCAL_YMS_ABBR	'%d.%m.%y'
FORMAT_LOCAL_Y	'%Y'
FORMAT_LOCAL_H	'%H'
FORMAT_LOCAL_S	'%S'
FORMAT_LOCAL_HM	'%H:%M'
FORMAT_LOCAL_HMS	'%H:%M:%S'
CHAR_LESS	'<'
CHAR_GREATER	'>'
CHAR_QUOTE	'"'
CHAR_APOSTROPHE	'''
CHAR_ARROWS	'»'
CHAR_ARROWS_R	'»'
CHAR_ARROWS_L	'«'
CHAR_AVERAGE	'Ø'
CHAR_INFIN	'∞'
CHAR_MILL	'‰'
CHAR_PLUSMN	'±'
CHAR_HELLIP	'…'
CHAR_CIRCA	'≈'
CHAR_CHECKBOX_EMPTY	'☐]'
CHAR_CHECKBOX_MAKRED	'☑'
CHAR_CHECKMARK	'✓'
CHAR_CHECKMARK_BOLD	'✔'
CHAR_BALLOT	'✗'
CHAR_BALLOT_BOLD	'✘'
CHAR_ABOUT	'≈'
CHAR_RPIME	'′'
CHAR_DOUBLE_RPIME	'″'

CakePHP Constants

Constant	Value
APP	'/var/www/html/ctr/app/'
APP_DIR	'app'
APPLIBS	'/var/www/html/ctr/app/Lib/'
CACHE	'/var/www/html/ctr/app/tmp/cache/'
CAKE	'/var/www/html/ctr/lib/Cake/'
CAKE_CORE_INCLUDE_PATH	'/var/www/html/ctr/lib'
CORE_PATH	'/var/www/html/ctr/lib/'
CAKE_VERSION	'2.2.2'
CSS	'/var/www/html/ctr/app/webroot/css/'
CSS_URL	'css/'
DS	'/'
FULL_BASE_URL	'https://ctr.pharmacyboardkenya.org'
IMAGES	'/var/www/html/ctr/app/webroot/img/'
IMAGES_URL	'img/'
JS	'/var/www/html/ctr/app/webroot/js/'
JS_URL	'js/'
LOGS	'/var/www/html/ctr/app/tmp/logs/'
ROOT	'/var/www/html/ctr'
TESTS	'/var/www/html/ctr/app/Test/'
TMP	'/var/www/html/ctr/app/tmp/'
VENDORS	'/var/www/html/ctr/vendors/'
WEBROOT_DIR	'webroot'
WWW_ROOT	'/var/www/html/ctr/app/webroot/'

PHP Environment

Environment Variable	Value
Php Version	'5.6.40-81+ubuntu20.04.1+deb.sury.org+1'
Redirect Redirect Https	'on'
Redirect Redirect Ssl Tls Sni	'ctr.pharmacyboardkenya.org'
Redirect Redirect Status	'200'
Redirect Https	'on'
Redirect Ssl Tls Sni	'ctr.pharmacyboardkenya.org'
Redirect Status	'200'
Https	'on'
Ssl Tls Sni	'ctr.pharmacyboardkenya.org'
Http Accept	'/'
Http User Agent	'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)'
Http Accept Encoding	'gzip, br, zstd, deflate'
Http Host	'ctr.pharmacyboardkenya.org'
Path	'/usr/local/sbin:/usr/local/bin:/usr/sbin:/usr/bin:/sbin:/bin:/snap/bin'
Server Signature	' Apache/2.4.41 (Ubuntu) Server at ctr.pharmacyboardkenya.org Port 443 '
Server Software	'Apache/2.4.41 (Ubuntu)'
Server Name	'ctr.pharmacyboardkenya.org'
Server Addr	'192.168.10.21'
Server Port	'443'
Remote Addr	'18.118.173.146'
Document Root	'/var/www/html/ctr'
Request Scheme	'https'
Context Prefix	''
Context Document Root	'/var/www/html/ctr'
Server Admin	'webmaster@localhost'
Script Filename	'/var/www/html/ctr/app/webroot/index.php'
Remote Port	'11454'
Redirect Url	'/app/webroot/applications/index/page:90/approved:2'
Gateway Interface	'CGI/1.1'
Server Protocol	'HTTP/1.1'
Request Method	'GET'
Query String	''
Request Uri	'/applications/index/page:90/approved:2'
Script Name	'/app/webroot/index.php'
Php Self	'/app/webroot/index.php'
Request Time Float	(float) 1746154346.145
Request Time	(int) 1746154346

====

Include
+
Included Files

Include Paths
- 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
- 1/var/www/html/ctr/lib
- 3/usr/share/php
- 4-> /var/www/html/ctr/lib/Cake/
Included Files
- core(array)
  Behavior(array)
  0CORE/Model/Behavior/TreeBehavior.php
  1CORE/Model/Behavior/ContainableBehavior.php
  2CORE/Model/Behavior/AclBehavior.php
  Cache(array)
  0CORE/Cache/Cache.php
  1CORE/Cache/Engine/FileEngine.php
  2CORE/Cache/CacheEngine.php
  Component(array)
  0CORE/Controller/Component/AclComponent.php
  1CORE/Controller/Component/Acl/DbAcl.php
  2CORE/Controller/Component/Acl/AclInterface.php
  3CORE/Controller/Component/AuthComponent.php
  4CORE/Controller/Component/RequestHandlerComponent.php
  5CORE/Controller/Component/SessionComponent.php
  6CORE/Controller/Component/PaginatorComponent.php
  Config(array)
  0CORE/Config/routes.php
  1CORE/Config/config.php
  Controller(array)
  0CORE/Controller/Controller.php
  1CORE/Controller/ComponentCollection.php
  2CORE/Controller/Component.php
  Datasource(array)
  0CORE/Model/Datasource/CakeSession.php
  1CORE/Model/Datasource/Database/Mysql.php
  2CORE/Model/Datasource/DboSource.php
  3CORE/Model/Datasource/DataSource.php
  Error(array)
  0CORE/Error/exceptions.php
  1CORE/Error/ErrorHandler.php
  I18n(array)
  0CORE/I18n/I18n.php
  1CORE/I18n/L10n.php
  Log(array)
  0CORE/Log/CakeLog.php
  1CORE/Log/LogEngineCollection.php
  2CORE/Log/Engine/FileLog.php
  3CORE/Log/Engine/BaseLog.php
  4CORE/Log/CakeLogInterface.php
  Model(array)
  0CORE/Model/ConnectionManager.php
  1CORE/Model/Permission.php
  2CORE/Model/Model.php
  3CORE/Model/BehaviorCollection.php
  4CORE/Model/Aro.php
  5CORE/Model/AclNode.php
  6CORE/Model/Aco.php
  7CORE/Model/ModelBehavior.php
  Network(array)
  0CORE/Network/CakeRequest.php
  1CORE/Network/CakeResponse.php
  Other(array)
  0CORE/bootstrap.php
  1CORE/basics.php
  2CORE/Core/App.php
  3CORE/Core/Configure.php
  4CORE/Core/CakePlugin.php
  5CORE/Event/CakeEventListener.php
  6CORE/Event/CakeEvent.php
  7CORE/Event/CakeEventManager.php
  8CORE/Core/Object.php
  Routing(array)
  0CORE/Routing/Dispatcher.php
  1CORE/Routing/Filter/AssetDispatcher.php
  2CORE/Routing/DispatcherFilter.php
  3CORE/Routing/Filter/CacheDispatcher.php
  4CORE/Routing/Router.php
  5CORE/Routing/Route/CakeRoute.php
  6CORE/Routing/Route/PluginShortRoute.php
  Utility(array)
  0CORE/Utility/Hash.php
  1CORE/Utility/Inflector.php
  2CORE/Utility/ObjectCollection.php
  3CORE/Utility/Debugger.php
  4CORE/Utility/String.php
  5CORE/Utility/ClassRegistry.php
  6CORE/Utility/Set.php
  7CORE/Utility/Sanitize.php
  View(array)
  0CORE/View/HelperCollection.php
- app(array)
  Behavior(array)
  0APP/Model/Behavior/SoftDeleteBehavior.php
  Config(array)
  0APP/Config/core.php
  1APP/Config/bootstrap.php
  2APP/Config/routes.php
  3APP/Config/database.php
  Controller(array)
  0APP/Controller/ApplicationsController.php
  1APP/Controller/AppController.php
  Model(array)
  0APP/Model/AppModel.php
  1APP/Model/Application.php
  2APP/Model/User.php
  3APP/Model/TrialStatus.php
  4APP/Model/InvestigatorContact.php
  5APP/Model/Sponsor.php
  6APP/Model/SiteDetail.php
  7APP/Model/County.php
  Other(array)
  0APP/webroot/index.php
- plugins(array)
  CakePdf(array)
  Config(array)
  0CakePdf/Config/bootstrap.php
  1CakePdf/Config/routes.php
  CakeResque(array)
  Config(array)
  0CakeResque/Config/bootstrap.php
  Plugin(array)
  0CakeResque/Lib/CakeResque.php
  1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
  2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
  3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  DebugKit(array)
  Component(array)
  0DebugKit/Controller/Component/ToolbarComponent.php
  Plugin(array)
  0DebugKit/Lib/DebugMemory.php
  1DebugKit/Lib/Panel/HistoryPanel.php
  2DebugKit/Lib/DebugPanel.php
  3DebugKit/Lib/Panel/SessionPanel.php
  4DebugKit/Lib/Panel/RequestPanel.php
  5DebugKit/Lib/Panel/SqlLogPanel.php
  6DebugKit/Lib/Panel/TimerPanel.php
  7DebugKit/Lib/Panel/LogPanel.php
  8DebugKit/Lib/Log/Engine/DebugKitLog.php
  9DebugKit/Lib/Panel/VariablesPanel.php
  10DebugKit/Lib/Panel/EnvironmentPanel.php
  11DebugKit/Lib/Panel/IncludePanel.php
  12DebugKit/Lib/DebugTimer.php
  Media(array)
  Config(array)
  0Media/Config/bootstrap.php
  Plugin(array)
  0Media/Lib/mm/src/Mime/Type.php
  1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
  2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
  3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
  4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
  5Media/Lib/mm/src/Media/Process.php
  6Media/Lib/mm/src/Media/Info.php
  Search(array)
  Component(array)
  0Search/Controller/Component/PrgComponent.php
  Behavior(array)
  0Search/Model/Behavior/SearchableBehavior.php
  Shim(array)
  Config(array)
  0Shim/Config/bootstrap.php
  Tools(array)
  Config(array)
  0Tools/Config/bootstrap.php
====

Clinical Trial Applications: Filter, Search, and view applications {lang: 'en-GB'}

Request History

Session

Request

Cake Params

Post data

Query string

Cookie

Current Route

Sql Logs

default

Total Time: 128 ms Total Queries: 12 queries

Query Explain:

Memory

Timers

Logs

View Variables

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

Included Files

Clinical Trial Applications: Filter, Search, and view applications

Total Time: 128 ms
Total Queries: 12 queries