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• applications(array)
  • 0(array)
    • Application(array)
      • id142
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n <font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">disease threat worldwide. Despite effective preventative measures and improvements in Highly </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. Part B is a randomized, placebo-controlled, double blind study to start after the product has been assessed as safe and tolerable in part A. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">may enhance immunogenicity without compromising safety.</font></font></font></p>\n
      • study_title<p>\n <font color=\"#010202\"><font face=\"Times New Roman\"><font size=\"3\">A Phase I Study of the Safety and Immunogenicity of PENNVAX™-G <font lang=\"KO\"><font lang=\"KO\"><font lang=\"KO\">DNA (Env & Gag) Administered by Intramuscular Biojector</font></font></font></font>^{<font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\">® </font></font></font>}<font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">2000 or by </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">CELLECTRA</font></font></font>^{<font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\"><font lang=\"KO\" size=\"1\">® </font></font></font>}<font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">Intramuscular Electroporation Device Followed by MVACMDR </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">(HIV-1 CM235 env/ CM240 gag/pol) Boost in Healthy, HIV </font></font></font><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\"><font lang=\"KO\" size=\"3\">Uninfected Adults</font></font></font></font></font></p>\n
      • laymans_summary<p>\n <font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">disease threat worldwide. Despite effective preventative measures and improvements in Highly </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. Part B is a randomized, placebo-controlled, double blind study to start after the product has been assessed as safe and tolerable in part A. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy </font></font></font><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\"><font color=\"#010202\" face=\"Times New Roman\" size=\"3\">may enhance immunogenicity without compromising safety.</font></font></font></p>\n
      • short_titlePENNVAX-G DNA/MVA HIV Vaccine Phase 1 trial
      • protocol_noECCT/11/12/04
      • version_no2.0
      • date_of_protocol20-01-2011
      • study_drugPENNVAXâ„¢-G DNA (HIV-1 env A,C and D, and consensus gag plasmids), MVA-CMDR Live attenuated Modified Vaccinia Ankara vector expressing HIV-1 CM235 env/ CM240 gag/pol, Placebo (Control)—Sodium Chloride Injection USP, 0.9%
      • disease_conditionHIV/AIDS
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjoel.chebon@usamru-k.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_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJosephat Kosgei
      • declaration_date105-06-2013
      • declaration_principal_investigatorFredrick Kipyego Sawe
      • declaration_date205-06-2013
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY OBJECTIVE</div>\n<div>\n §ï‚§ To evaluate the safety and tolerability of PENNVAX™-G DNA (env& gag)</div>\n<div>\n administered by IM Biojector® 2000 or IM CELLECTRA® electroporation followed</div>\n<div>\n by IM MVA-CMDR (HIV-1 CM235 env/ CM240 gag/pol) boost in healthy HIVuninfected</div>\n<div>\n adult participants.</div>\n<div>\n 3.2 SECONDARY OBJECTIVE</div>\n<div>\n §ï‚§ To evaluate the ability of PENNVAX™-G DNA (env& gag) and MVA-CMDR</div>\n<div>\n (HIV-1 CM235 env/ CM240 gag/pol) in a DNA/MVA prime/boost strategy to induce</div>\n<div>\n HIV antigen specific cellular and humoral immune responses.</div>\n<div>\n 3.2.1 MUCOSAL SUBSTUDY OBJECTIVES</div>\n<div>\n §ï‚§ Evaluate the acceptability, feasibility, and quality of mucosal collection using the</div>\n<div>\n Instead Softcup method.</div>\n<div>\n §ï‚§ Characterize the humoral responses in the mucosal compartments in the vaccine and</div>\n<div>\n placebo recipients.</div>\n<div>\n §ï‚§ Characterize the humoral response in the mucosal compartment in volunteers</div>\n<div>\n receiving DNA alone versus MVA boost.</div>\n<div>\n §ï‚§ Characterize the humoral responses in the mucosal compartments in volunteers</div>\n<div>\n receiving DNA by Biojector or EP.</div>\n
      • principal_inclusion_criteria<ol>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">HIV un-infected, healthy adults</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">18-49 years at the time of enrolment</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">Low risk for HIV infection</span></span></span></li>\n <li>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 16px;\"><span lang=\"EN-GB\" style=\"color: black;\">Availability and willingness to participate for the duration of the study</span></span></span></li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">HIV infection</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">A woman who is pregnant, planning on becoming pregnant or breastfeeding</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">High risk for HIV infection</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\">Any clinically significant medical condition that in the opinion of the investigator would    preclude participation</span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">History of anaphylaxis or other serious adverse reactions to vaccines or egg products</font></span></span></span></li>\n <li>\n <span style=\"font-size: 16px;\"><span style=\"font-family: arial,helvetica,sans-serif;\"><span lang=\"EN-GB\"><font color=\"#000000\">Recipient of HIV vaccine candidate at any time</font></span></span></span></li>\n</ol>\n
      • primary_end_points<p>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><strong><u>Safety</u></strong></span></span></p>\n<p>\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\">Safety assessments will be made throughout the trial to evaluate local toxicity (reactogenicity) and systemic reactions (adverse events) by means of clinical evaluation and clinical tests: hematology, blood chemistry and urinalysis. Safety endpoints will include severe local toxicity at injection site and severe systemic symptoms judged to be probably or definitely related to the vaccine.</span></span></p>\n<p>\n <u><span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><strong><font color=\"#010202\"><font color=\"#010202\"><font color=\"#010202\">Immunogenicity</font></font></font></strong></span></span></u></p>\n<p align=\"LEFT\">\n <span style=\"font-family: arial,helvetica,sans-serif;\"><span style=\"font-size: 12px;\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">The study is descriptive and exploratory in nature and is not powered to detect significant differences in cell-mediated or humoral immune responses. Immunogenicity responses will be </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">measured in placebo recipients but will not be compared to responses among vaccine recipients. </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">For all assays, specificity will be assessed by defining the false positive rates using all baseline </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">(pre-vaccination) and placebo samples in aggregate. For the analysis of immunogenicity, groups </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">I and III (Biojector</font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">® </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">groups) will be combined and groups II and IV (Electroporation groups) </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">will be combined. For each assay, response rates and response magnitude (as appropriate) will be </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">described for the Biojector </font></font></font><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\"><font color=\"#010202\" lang=\"KO\">groups and Electroporation groups for the vaccine recipients and placebo recipients separately.</font></font></font></span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n As indicated on the attached Site Specific Addendum.</p>\n
      • other_details_explanation<p>\n The trial is being conducted both in Kenya and Host country.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n <span lang=\"EN-GB\" style=\"font-family: ;\"><strong><font color=\"#000000\">Walter Reed Army Institute of Research IRB Approval with stipulations on 13 April 2011</font></strong></span>,</p>\n<p>\n <span lang=\"EN-GB\" style=\"font-family: ;\"><strong><font color=\"#000000\">KEMRI ERC</font></strong></span> -<strong> <span style=\"font-size: 16px;\">03 JAN 2013</span></strong></p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationThe active phase of the study will last 15 months followed by 18 months of passive follow-up.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/Walter Reed Project-Kericho
      • single_site_physical_addressClinical Research Center, Off Hospital Road, Kericho.
      • single_site_contact_personFred SAWE
      • single_site_telephone052 30686
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listKenya, Uganda, Tanzania, United States of America
      • data_monitoring_committeeYes
      • total_enrolment_per_site20
      • total_participants_worldwide92
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • 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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailfsawe@hivresearch.org
      • organisations_transferred_Yes
      • number_participants20
      • notification<p>\n THe trial has been previously approved and is being uploaded at the request of ECCT secretariat for purposes of updating the trials database.</p>\n<p>\n  </p>\n
      • approval_date15-02-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The HIV vaccine study completed enrollment, follow-up and all study participants exited the study. The primary analysis is complete and findings published.</p>\n<p>\n  </p>\n<p>\n Executive Summary as uploaded under notifications.</p>\n
      • implication_results<p>\n Publications uploaded. The results of the study importatant in the continued efforts in HIV vaccine development.</p>\n
      • quantity_imported30
      • quantity_dispensed22
      • quantity_destroyed8
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2020-09-11 13:05:02
      • created2013-06-04 09:56:15
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id87
        • application_id142
        • given_nameFREDRICK
        • middle_nameKIPYEGO
        • family_nameSAWE
        • qualificationMBChB, MMED
        • professional_addressP.O Box 1357, 20200, Kericho, Kenya
        • telephone(254-52) 30686,30388
        • emailfsawe@wrp-kch.org
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
    • SiteDetail(array)
      • 0(array)
        • id109
        • application_id142
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id68
        • application_id142
        • sponsorDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases US National Institute of Health
        • sponsor_typeOthers
        • contact_person
        • address6700 B Rockledge Drive, Bethesda, MD 20817
        • telephone_number+301-435-3734
        • fax_number+301-402-1506
        • cell_number+301-435-3734
        • email_addressviseth.ngauy@us.army.mil
        • created2013-06-04 12:00:11
        • modified2020-07-17 09:39:08
  • 1(array)
    • Application(array)
      • id141
      • user_id77
      • trial_status_id5
      • abstract_of_study<div>\n Titke: Plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of</div>\n<div>\n HIV-1 In Serodiscordant Couples</div>\n<div>\n Purpose: The purpose of this study is to determine whether antiretroviral therapy (ART) can</div>\n<div>\n prevent the sexual transmission of HIV-1 in HIV-1 serodiscordant couples.</div>\n<div>\n Design: The study is a Phase III, two-arm, randomized, controlled, multi-center trial. This trial</div>\n<div>\n consists of a run-in period, which has been completed, and a full study.</div>\n<div>\n Study Population: HIV serodiscordant couples in which the HIV-infected partner is ART-naive and</div>\n<div>\n has a CD4+ cell count of 350-550 cells/mm3.</div>\n<div>\n Study Size: Approximately 1750 couples total</div>\n<div>\n Study Arms: HIV-infected index cases will be assigned at random in a 1:1 ratio to one of two</div>\n<div>\n treatment arms:</div>\n<div>\n Arm 1: ART upon enrollment plus HIV primary care.</div>\n<div>\n Arm 2: HIV primary care without initiation of ART until the participant has two consecutive</div>\n<div>\n measurements of a CD4+ cell count within or below the range of 200-250</div>\n<div>\n cells/mm3, or develops an AIDS-defining illness.</div>\n<div>\n The ART drugs provided through the study include Combivir® [3TC/zidovudine(ZDV)],</div>\n<div>\n efavirenz [EFV], atazanavir [ATV], nevirapine [NVP], tenofovir [TDF], lamivudine [3TC],</div>\n<div>\n didanosine [ddI-EC], stavudine [d4T], Kaletra®/Aluvia® [lopinavir(LPV)/ritonavir (r)], and</div>\n<div>\n Truvada® [emtricitabine (FTC)/tenofovir (TDF)].</div>\n<div>\n Study Duration: The duration of the full study will be approximately 78 months total. Accrual</div>\n<div>\n into the study will require approximately 18 months total, and all couples will be followed until</div>\n<div>\n the last couple enrolled completes their 60-month follow-up visit.</div>\n<div>\n Study Objectives:</div>\n<div>\n The primary objective of the study is to compare the rates of HIV infection among partners of</div>\n<div>\n HIV-infected participants in the two study arms below:</div>\n<div>\n (1) ART upon enrollment plus HIV primary care.</div>\n<div>\n (2) HIV primary care without initiation of ART until the participant has two consecutive</div>\n<div>\n measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3,</div>\n<div>\n or develops an AIDS-defining illness.</div>\n<div>\n HPTN 052 Final Version 3.0, 20 November 2006 Page 16 of 173</div>\n<div>\n  </div>\n<div>\n The secondary objectives of the study are to:</div>\n<div>\n • Determine the long-term safety of two antiretroviral treatment strategies (i.e., immediate</div>\n<div>\n upon enrollment vs. ART initiation when the participant has two consecutive</div>\n<div>\n measurements of a CD4+ cell count within or below the range of 200-250 cells/mm3,</div>\n<div>\n or develops an AIDS-defining illness).</div>\n<div>\n • Characterize and compare the patterns and rates of antiretroviral drug resistance of two</div>\n<div>\n antiretroviral treatment strategies.</div>\n<div>\n • Assess factors associated with adherence and compare the adherence rate of two</div>\n<div>\n antiretroviral treatment strategies.</div>\n<div>\n • Evaluate the usefulness of measures of virologic and immunologic efficacy, and measures</div>\n<div>\n to detect antiretroviral drug resistance.</div>\n<div>\n • Determine, characterize, and compare the rates of AIDS-defining illnesses, sexually</div>\n<div>\n transmitted diseases, opportunistic infections, and immune reconstitution syndromes, with</div>\n<div>\n regard to outcomes and survival as observed in different geographic settings and by</div>\n<div>\n antiretroviral treatment strategies.</div>\n<div>\n • Determine and characterize the rates of antiretroviral drug-associated toxicities observed</div>\n<div>\n in different geographic settings and by treatment strategies.</div>\n<div>\n • Evaluate the effectiveness of couples HIV counseling and characterize the patterns of</div>\n<div>\n sexual behavior in couples in both arms of the study.</div>\n<div>\n • Characterize and compare Quality-of-Life (QOL) indicators in different geographic</div>\n<div>\n settings and by antiretroviral treatment strategies.</div>\n<div>\n Study Sites:</div>\n<div>\n • Porto Alegre, Brazil</div>\n<div>\n • Rio de Janeiro, Brazil</div>\n<div>\n • Chennai, India</div>\n<div>\n • Pune, India</div>\n<div>\n • Blantyre, Malawi</div>\n<div>\n • Lilongwe, Malawi</div>\n<div>\n • Chiang Mai, Thailand</div>\n<div>\n • Boston, Massachusetts, United States of America</div>\n<div>\n • Harare, Zimbabwe</div>\n
      • study_title<div>\n A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy</div>\n<div>\n plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual</div>\n<div>\n Transmission of HIV-1 In Serodiscordant Couples</div>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/09/06/02
      • version_no3.0
      • date_of_protocol20-11-2006
      • study_drugCombivir® [3TC/ZDV], efavirenz [EFV], atazanavir [ATV], nevirapine [NVP], tenofovir [TDF], lamivudine [3TC], didanosine [ddI-EC], stavudine [d4T], Aluvia® [LPV/r], and Truvada® [FTC/TDF]
      • disease_conditionHIV/AIDS
      • 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_nameCombivir® [3TC/ZDV], efavirenz, atazanavir, nevirapine, tenofovir, lamivudine, didanosine, stavudine, Lopinavir/ritonavir, 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_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_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_applicantElizabeth Ayuo
      • declaration_date103-07-2013
      • declaration_principal_investigatorLisa A. Mills
      • declaration_date203-07-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n Couples are defined as sexual partners, same or opposite sex, who are married, have been</div>\n<div>\n living together, or consider each other a primary partner. They must have been together</div>\n<div>\n for a minimum of three months, and at the time of study enrollment expect to maintain</div>\n<div>\n their relationship for the duration of the study.</div>\n<div>\n Additional sexual partners of either the index case or their partner will not be eligible to</div>\n<div>\n enroll while the initial couple enrolled is being followed. Each partner of an HIV</div>\n<div>\n serodiscordant couple must meet the criteria presented below to be eligible for inclusion</div>\n<div>\n in this study.</div>\n<div>\n Whether individual HBV/HIV coinfected persons are enrolled into HPTN 052 will be left</div>\n<div>\n to the discretion of the site investigator.</div>\n<div>\n HPTN 052 Final Version 3.0, 20 November 2006 Page 45 of 173</div>\n<div>\n 3.1.1 Index Case</div>\n<div>\n • Positive HIV serology obtained within 60 days prior to enrollment</div>\n<div>\n Note: Confirmation of the initial positive or discordant test results (the initial test</div>\n<div>\n may be the results from two rapid tests) must use a test that is different than the</div>\n<div>\n one used for the initial assessment. Initially reactive rapid tests should be</div>\n<div>\n confirmed by Western blot or a plasma HIV-1 RNA. An initial ELISA result must</div>\n<div>\n be confirmed with another method such as Western blot or plasma HIV-1 RNA,</div>\n<div>\n but not by a repeat ELISA test.</div>\n<div>\n • Has a sexual partner (as defined above) who is not infected with HIV</div>\n<div>\n (documented by negative HIV serology), and who is willing to participate in the</div>\n<div>\n study.</div>\n<div>\n • Plans to maintain a sexual relationship with the person who is enrolled in the study</div>\n<div>\n with them.</div>\n<div>\n • Reports having sex (vaginal or anal) with partner at least 3 times in the last 3</div>\n<div>\n months.</div>\n<div>\n • If pregnant or breastfeeding during screening or at the time of enrollment, willing</div>\n<div>\n to be randomized to either arm of the study.</div>\n<div>\n Note: If a woman is in her first trimester during screening, the HPTN 052 CMC</div>\n<div>\n must be consulted prior to her enrollment.</div>\n<div>\n • The following conditions must be met for laboratory parameters within 60 days</div>\n<div>\n prior to enrollment:</div>\n<div>\n ô€‚ƒ CD4+ cell count of 350-550 cells/mm3</div>\n<div>\n ô€‚ƒ Hemoglobin > 7.5 g/dL (see Section 4.5.5.5 for information on anemia)</div>\n<div>\n ô€‚ƒ Platelet count > 50,000/µL.</div>\n<div>\n ô€‚ƒ AST (SGOT), ALT (SGPT), and alkaline phosphatase < 5 x ULN</div>\n<div>\n ô€‚ƒ Total bilirubin < 2.5 x ULN</div>\n<div>\n ô€‚ƒ Calculated creatinine clearance > 60 mL/min (use the Cockcroft and Gault</div>\n<div>\n method to calculate)</div>\n<div>\n ô€‚ƒ Absolute neutrophil count > 750 mm3 or 0.750 x 109/L (see Section 4.5.5.5</div>\n<div>\n for information on neutropenia)</div>\n<div>\n HPTN 052 Final Version 3.0, 20 November 2006 Page 46 of 173</div>\n<div>\n 3.1.2 Partner</div>\n<div>\n • Negative HIV serology within 14 days prior to enrollment.</div>\n<div>\n Note: If the initial test is two negative rapid tests, the participant will be considered</div>\n<div>\n HIV-negative and no further testing is required. If the initial test is a non-reactive</div>\n<div>\n EIA, the participant will be considered HIV-negative and no further testing is</div>\n<div>\n required.</div>\n<div>\n • Has a sexual partner infected with HIV who is willing to participate in the study.</div>\n<div>\n • Plans to maintain a sexual relationship with the person who is enrolled in the study</div>\n<div>\n with them.</div>\n<div>\n • Reports having sex (vaginal or anal) with partner at least 3 times in the last 3</div>\n<div>\n months.</div>\n<div>\n 3.1.3 Both Index Case and Partner</div>\n<div>\n • Men and women age > 18 years.</div>\n<div>\n • Willing to disclose HIV test results to partner.</div>\n<div>\n • Not intending to relocate out of the area for the duration of study participation and</div>\n<div>\n does not have a job or other obligations that may require long absences from the</div>\n<div>\n area.</div>\n
      • principal_exclusion_criteria<div>\n Index Case</div>\n<div>\n • Current or previous AIDS-defining illness (as defined in Appendix III). (Note:</div>\n<div>\n active TB, as defined by the ACTG Appendix 60 - Diagnoses Appendix, is an</div>\n<div>\n exclusion, as well as currently being on intensive phase of TB treatment, but</div>\n<div>\n previously treated cases of pulmonary TB may be waived at the discretion of the</div>\n<div>\n study clinician.)</div>\n<div>\n • Current or previous use of any ART drugs (exceptions will be outlined in the SSP</div>\n<div>\n Manual. For example, previous short-term use of ART for prevention of perinatal</div>\n<div>\n transmission will be waived as an exclusion).</div>\n<div>\n • Documented or suspected acute hepatitis within 30 days prior to enrollment,</div>\n<div>\n irrespective of AST (SGOT) and ALT (SGPT) values.</div>\n<div>\n • Acute therapy for serious medical illnesses, in the opinion of the site investigator,</div>\n<div>\n within 14 days prior to enrollment. Candidates with chronic, acute, or recurrent</div>\n<div>\n infections that are serious, in the opinion of the site investigator, who must</div>\n<div>\n HPTN 052 Final Version 3.0, 20 November 2006 Page 47 of 173</div>\n<div>\n continue with chronic (maintenance) therapy (e.g., TB), must have completed at</div>\n<div>\n least 14 days of therapy prior to study entry and be clinically stable.</div>\n<div>\n • Radiation therapy or systemic chemotherapy within 45 days prior to enrollment.</div>\n<div>\n NOTE: Anticipated need for systemic chemotherapy while on study is not</div>\n<div>\n permitted.</div>\n<div>\n • Any immunomodulator or other investigational therapy within 30 days prior to</div>\n<div>\n enrollment.</div>\n<div>\n • Active drug or alcohol use or dependence that, in the opinion of the site</div>\n<div>\n investigator, would interfere with adherence to study requirements.</div>\n<div>\n • Vomiting or inability to swallow medications due to an active, pre-existing</div>\n<div>\n condition that prevents adequate swallowing and absorption of study medication.</div>\n<div>\n • Need for a prohibited medication listed in Section 4.3.2.</div>\n<div>\n • Allergy/sensitivity to any study drugs or their formulations.</div>\n<div>\n 3.2.2 Both Index Case and Partner</div>\n<div>\n • Reports a history of injection drug use within the last five years.</div>\n<div>\n • Previous and/or current participant in an HIV vaccine study.</div>\n<div>\n • Any condition that, in the opinion of the study staff, would make participation in</div>\n<div>\n the study unsafe, complicate interpretation of study outcome data, or</div>\n<div>\n otherwise interfere with achieving the study objectives.</div>\n<div>\n • Incarceration in a correctional facility, prison, or jail; and involuntary</div>\n<div>\n incarceration in a medical facility for psychiatric or physical (e.g. infectious</div>\n<div>\n disease) illness.</div>\n<div>\n 3.3 Screening and Enrollment Procedures</div>\n<div>\n Identification of HIV serodiscordant couples will vary across sites and within an</div>\n<div>\n individual site (e.g. couples already identified as HIV serodiscordant and referred to the</div>\n<div>\n site by a local voluntary counseling and testing (VCT) center, referral of HIV-infected</div>\n<div>\n individuals from local STD/HIV clinics or other research protocols, or referral of</div>\n<div>\n HIV-uninfected individuals to the study site). Thus, it will be the responsibility of each</div>\n<div>\n participating site to determine the best screening methods for their locale, and will likely be</div>\n<div>\n dictated on a case-by-case basis.</div>\n<div>\n The protocol will not define an algorithm for HIV screening for study eligibility. Study</div>\n<div>\n sites will be responsible for developing a local SOP for this study component; however,</div>\n<div>\n the HPTN Central Laboratory should approve the screening algorithm employed. In</div>\n<div>\n HPTN 052 Final Version 3.0, 20 November 2006 Page 48 of 173</div>\n<div>\n addition, previous HIV screening with positive test results will be accepted as eligibility</div>\n<div>\n for this study only if:</div>\n<div>\n • the testing occurred within the dictated timeframe for this study (within 60 days)</div>\n<div>\n • the testing was performed during a time that the site had HPTN Central</div>\n<div>\n Laboratory certificate of accreditation</div>\n<div>\n • the testing has appropriate documentation (i.e. documentation is consistent with</div>\n<div>\n what would otherwise be required for research purposes such as test date, test</div>\n<div>\n results, and identification of the testing laboratory)</div>\n
      • primary_end_points<p>\n Seroconversion of the index participant</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • 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_other1
      • trial_other_specifyInvestigational New drug
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Site Principal Investigator (PI):               Lisa A. Mills, MD, MS</p>\n<p>\n Co-investigators:                                   Kayla Laserson,</p>\n<p>\n                                                                     Charles LeBaron, MD</p>\n<p style=\"margin-left:2.5in;\">\n Debra Gust PhD;</p>\n<p style=\"margin-left:2.5in;\">\n Robert T Chen, MD, MA</p>\n<p style=\"margin-left:2.5in;\">\n Clement Zeh, BSc</p>\n<p style=\"margin-left:2.5in;\">\n Victor Akelo, MD</p>\n<p style=\"margin-left:2.5in;\">\n Kevin Cain, MD, MPH</p>\n<p style=\"margin-left:2.5in;\">\n Videlis Nduba, MD, MPH</p>\n<p style=\"margin-left:2.5in;\">\n Ephantus Wanjema, MD</p>\n<p style=\"margin-left:2.5in;\">\n Richard Lando, DCM</p>\n<p style=\"margin-left:2.5in;\">\n Beatrice Nyagol, DCM</p>\n<p>\n Study Medical Officer:                           Victor Akelo, MD</p>\n<p>\n Study Coordinator:                                Arthur Ogendo BA</p>\n<p>\n Study Pharmacist:                                 Victor Mudhune, B. Pharm</p>\n<p>\n Laboratory Director:                              Clement Zeh, BSc</p>\n<p>\n Data Section Chief:                               Richard Ndivo, BSc</p>\n<p>\n Regulatory Officer:                                Elizabeth Ayuo, BA</p>\n<p>\n Behavioral Scientist:                              Mary Nyikuri, MA</p>\n<p>\n HIV Research Branch Chief:                   Lisa A. Mills, MD, MS</p>\n<p>\n HIV Research Branch Deputy:                Ray Goldstine, Pharm D</p>\n<p style=\"margin-left:2.5in;\">\n Kevin Cain, MD, MPH</p>\n<p style=\"margin-left:2.5in;\">\n Videlis Nduba, MD, MPH</p>\n<p style=\"margin-left:2.5in;\">\n Ephantus Wanjema, MD</p>\n<p style=\"margin-left:2.5in;\">\n Richard Lando, DCM</p>\n<p style=\"margin-left:2.5in;\">\n Beatrice Nyagol, DCM</p>\n<p>\n Study Medical Officer:                           Victor Akelo, MD</p>\n<p>\n Study Coordinator:                                Arthur Ogendo BA</p>\n<p>\n Study Pharmacist:                                 Victor Mudhune, B. Pharm</p>\n<p>\n Laboratory Director:                              Clement Zeh, BSc</p>\n<p>\n Data Section Chief:                               Richard Ndivo, BSc</p>\n<p>\n Regulatory Officer:                                Elizabeth Ayuo, BA</p>\n<p>\n Behavioral Scientist:                              Mary Nyikuri, MA</p>\n<p>\n HIV Research Branch Chief:                   Lisa A. Mills, MD, MS</p>\n<p>\n HIV Research Branch Deputy:                Ray Goldstine, Pharm D</p>\n
      • other_details_explanation<p>\n the study was conducted in the US in its early enrollment., Site: Boston Massachusettes</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI Ethics Review Committee and Scientific Steering Committe - 06MAY2013</p>\n<p>\n CDC Ethics Review Committe - 12FEB2013</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration6 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPrimary care only
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKisumu, Kenya
      • single_site_physical_addressOngielo Health Centre, off Luanda K\'otieno Road, Asembo.
      • single_site_contact_personDr. Lisa Mills
      • single_site_telephone+254572022929
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states1750
      • number_of_sites
      • multi_country_listPorto Alegre, Brazil\n• Rio de Janeiro, Brazil\n• Chennai, India\n• Pune, India\n• Blantyre, Malawi\n• Lilongwe, Malawi\n• Chiang Mai, Thailand\n• Boston, Massachusetts, United States of America\n• Harare, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site60 couples
      • total_participants_worldwide1750 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • 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_othersNo
      • subjects_others_specify
      • investigator1_given_nameLisa
      • investigator1_middle_nameAnn
      • investigator1_family_nameMills
      • investigator1_qualificationMD
      • investigator1_professional_address1578-40100, Kisumu
      • investigator1_telephone+254-57-2022929
      • investigator1_emailLmills@ke.cdc.gov
      • organisations_transferred_Yes
      • number_participants100 couples
      • notification<p>\n NONE</p>\n
      • approval_date05-07-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-07-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n 1.    HPTN 052 is the first randomized clinical trial to show that treating HIV-infected individuals with antiretroviral therapy (ART) early in their HIV infection (CD4 cell count 350-550/mm³) reduces the risk of sexual transmission of HIV to their uninfected partners, and also provides a clear clinical benefit to the HIV-infected individual; notably, early ART leads to a longer duration of time without diseases such as tuberculosis and other targeted clinical events.</p>\n<p>\n  </p>\n<p>\n 2.    ART reduced HIV acquisition by 93% in the entire study, which is similar to the 96% reduction reported in the interim analysis in 2011. </p>\n<p>\n  </p>\n<p>\n 3.    Virologically-linked partner infections were not observed when the index participant was stably suppressed on ART.</p>\n<p>\n  </p>\n<p>\n 4.    ART, when taken until viral suppression is achieved and sustained, is a highly effective, durable intervention for HIV prevention.</p>\n<p>\n  </p>\n<p>\n HPTN 052 was funded by the funded by the National Institute for Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-10-28 16:56:58
      • created2013-05-31 14:03:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id98
        • application_id141
        • given_nameLisa
        • middle_nameAnn
        • family_nameMills
        • qualificationMD
        • professional_address1578-40100 Kisumu
        • telephone+254-57-2022929
        • emailvmudhune@ke.cdc.gov
        • created2013-06-19 15:57:10
        • modified2013-07-03 12:56:14
    • SiteDetail(array)
      • 0(array)
        • id125
        • application_id141
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-06-19 15:57:10
        • modified2013-07-03 12:56:14
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id79
        • application_id141
        • sponsorDivision of AIDS, U.S. National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_personBola Adedeji
        • addressInternational Health Programs Specialist Office of Clinical Site Oversight (OCSO) OD/DAIDS/NIAID/NIH/DHHS 6700B Rockledge Drive, Room 5111 MSC 7624 Bethesda, MD 20892-7624 express mail: Bethesda, MD 20817
        • telephone_number(301) 496-7122
        • fax_number(301) 480-7675
        • cell_number(301) 496-7122
        • email_addressBAdedeji@niaid.nih.gov
        • created2013-06-19 15:57:10
        • modified2013-07-03 12:56:14
  • 2(array)
    • Application(array)
      • id137
      • user_id21
      • trial_status_id8
      • abstract_of_study<div>\n <p>\n <u>DESIGN</u>          In this randomized, open-label, phase IV strategy trial, participants from resource-limited settings (RLS) who present with advanced HIV disease and no probable or confirmed tuberculosis (TB), as defined in the current ACTG diagnosis appendix, and who are initiating antiretroviral treatment (ART) will be randomized to one of two strategy arms: immediate, empiric TB treatment (public health approach) or local standard of care TB treatment (individualized approach). The primary endpoint is survival status in the two arms 24 weeks after randomization. AIDS progression (any new WHO Stage 3 or 4 condition), virologic and CD4+ cell response, HIV and TB drug resistance, AND safety and tolerability of, and adherence to HIV and TB drugs will be evaluated, as will the cost-effectiveness of the two strategies.</p>\n <p>\n <u>DURATION</u>    96 weeks. Participants will transition to locally provided care and treatment at week 48.</p>\n <p>\n <u>SAMPLE SIZE</u>            836 participants</p>\n <p style=\"margin-left: 40px;\">\n <u>POPULATION</u>            HIV-infected antiretroviral-naïve males and females aged 13 years and older, with CD4+ cell count <50 cells/mm³ who are initiating ART. Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area) of more than 100 cases/100,000 population per year, a national ART program, and documented high mortality rates among HIV-infected individuals (i.e., at least 5% overall at 6 months post ART initiation). Sites whose regional TB incidence or mortality rates approach but do not meet the requirements stated above may be approved on a case-by-case basis by the study team, following a review of all relevant information. Participants with probable or confirmed TB at screening will be excluded.</p>\n <p style=\"margin-left: 40px;\">\n <u>RANDOMIZATION</u>    1:1 to empiric or local standard of care TB treatment</p>\n <p style=\"margin-left: 40px;\">\n Participants will be randomized to initiate TB treatment either at entry (Arm A, empiric) or when indicated according to local practice and the discretion of the site investigator (Arm B, local standard of care).</p>\n <p style=\"margin-left: 40px;\">\n <u>STRATIFICATION</u>     Randomization will be stratified according to CD4+ cell count (<25 vs. ≥25 cells/mm³) and presence of poor prognostic factors (i.e., absence of all vs. presence of at least one of the following: reportable hospitalization [see section 6.3.5) within the past 30 days, body mass index [BMI] <18.5, or anemia [hemoglobin <8 g/dl]).</p>\n <p>\n <u>REGIMEN</u>      Section 5.1 provides detailed information about treatment options and their provision.</p>\n <p>\n                         All participants will receive efavirenz-(EFV) based ART beginning at study entry.  </p>\n <p>\n The TB treatment described below must be obtained by the sites as described in section 5.3.1.</p>\n <p>\n Pyridoxine will be provided by the sites to all participants while they are receiving isoniazid (INH) to prevent emergence of neuropathy associated with INH use. All participants will be provided <em>Pneumocystis jiroveci </em>pneumonia (PCP) prophylaxis by the sites according to local guidelines.</p>\n <p>\n Regimens by arm:</p>\n <p style=\"margin-left: 40px;\">\n <u>Arm A (empiric)</u></p>\n <p>\n EFV-based ART (see section 5.1.1)</p>\n <p>\n Plus  </p>\n <p>\n Full TB treatment course, defined as:</p>\n <ul>\n <li>\n <p>\n rifampin/isoniazid/ethambutol/pyrazinamide (RIF/INH/EMB/PZA) for 8 weeks,</p>\n </li>\n </ul>\n <p>\n followed by</p>\n <ul>\n <li>\n <p>\n RIF/INH only for 16 weeks</p>\n </li>\n </ul>\n <p>\n <u>Arm B Regimen (standard of care)</u></p>\n <p>\n EFV-based ART alone</p>\n <p>\n If TB treatment is subsequently indicated for participants in either arm according to local standard practice and/or discretion of site investigator, then the TB treatment described above should be initiated.</p>\n <p style=\"margin-left: 40px;\">\n  </p>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n A5274/REMEMBER "Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens"</p>\n
      • laymans_summary<p>\n In this randomized, open-label strategy trial, participants from RLS who present with advanced HIV disease and will be initiating ART but are without evidence of probable or confirmed TB according to criteria in the current ACTG diagnosis appendix (which will be identified on the case report form [CRF]) will be randomized 1:1 to one of two strategy arms: empiric TB treatment (public health approach, Arm A) or local standard of care (individualized TB treatment approach, Arm B) at study entry. At the 48 week visit, participants will transition to a 48-week follow-up period of non-study-provided treatment and care, with total study duration being 96 weeks.</p>\n<p>\n The primary endpoint is survival status at 24 weeks post randomization. AIDS progression, virologic and immunologic response, development of plasma HIV drug resistance, resistance to TB drugs, safety and tolerability of ART and TB drugs, and adherence to ART and TB drugs will also be evaluated as will the relative cost-effectiveness of the two strategies.</p>\n
      • short_titleREMEMBER
      • protocol_noECCT/11/07/02
      • version_noVersion 1.0
      • date_of_protocol29-10-2010
      • study_drugRifampin/Isoniazid/Pyrazinamide/Ethambutol
      • disease_conditionEmpiric treatment of TB
      • 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_nameFDC RHZE, FDC RH
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaksudoi@hotmail.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_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantAllan K Sudoi
      • declaration_date131-05-2013
      • declaration_principal_investigatorAbraham M Siika, MBChB, MMed, Msc - Site Principal Investigator
      • declaration_date231-05-2013
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objective</h2>\n<p>\n  </p>\n<p style=\"margin-left:36.0pt;\">\n To compare survival probabilities between the two study arms 24 weeks after randomization.</p>\n<p>\n  </p>\n<h2>\n  Secondary Objectives</h2>\n<p>\n  </p>\n<ol>\n <li>\n To compare the time to death between the two arms.</li>\n <li>\n To compare the time to AIDS progression or death between the two arms.</li>\n <li>\n To compare the survival without AIDS progression 24 and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare Probabilities of plasma HIV-1 RNA levels of <400 copies/mL at 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare rates of safety and tolerability (including Grades 3 and 4 events, immune reconstitution inflammatory syndrome [IRIS] events, ART and TB treatment changes, and rates/causes of reportable hospitalization) of ART and TB treatment 24 and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare changes in CD4+ cell counts 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare cause of death, including TB-specific mortality, between the two arms through 96 weeks.</li>\n <li>\n To compare ART adherence by self-report 4, 24, and 48 weeks after randomization between the two arms.</li>\n <li>\n To compare TB incidence between the two arms from randomization through week 48 and week 96.</li>\n <li>\n To explore TB incidence by geographic region and by arm.</li>\n <li>\n To compare adherence to TB treatment between the two arms while participants are receiving TB treatment.</li>\n <li>\n To compare resistance to TB drugs at time of incident TB between the two arms.</li>\n <li>\n To compare cost-effectiveness of the treatment strategies between the two arms.</li>\n <li>\n To compare quality of life between the two arms.</li>\n <li>\n To compare cost effectiveness of intervention by intensity of TB evaluation practices.</li>\n <li>\n To evaluate the evolution of plasma HIV-1 drug resistance through week 48.</li>\n <li>\n To evaluate issues related to dietary intake and food insecurity and their relation to early mortality.</li>\n <li>\n To assess the relationship between levels of bacterial and/or fungal DNA in plasma at study entry and during ART treatment and survival at 24 weeks.</li>\n</ol>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n
      • principal_inclusion_criteria<p>\n Contained in section 4.1 of the protocol</p>\n<h2>\n 4.1       Inclusion Criteria</h2>\n<p style=\"margin-left: 80px;\">\n 4.1.1    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 by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 80px;\">\n The WHO and the U.S. Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 80px;\">\n NOTE: The term “licensed” refers to a kit that has been certified or licensed by an oversight body within the country in which it is used and has been validated internally.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.2    Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.3    CD4+ cell count <50 cells/mm³ obtained within 45 days prior to study entry at any laboratory that has a CLIA certification or its equivalent.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.4    Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and total bilirubin ≤ 2.5 X ULN within 30 days prior to study entry.</p>\n<ol>\n <li value=\"NaN\">\n <p>\n Creatinine clearance ≥30 mL/min either measured or estimated* using values obtained within 30 days prior to study entry.  </p>\n </li>\n</ol>\n<p style=\"margin-left: 80px;\">\n *If not measured, then creatinine clearance must be estimated using the Cockcroft-Gault equation which is available at <a href=\"https://www.fstrf.org/\">https://www.fstrf.org</a></p>\n<p style=\"margin-left: 80px;\">\n under Calculators/Calculator Utilities.</p>\n<ol start=\"2\">\n <li>\n <p>\n Results from a hepatitis B surface antigen test performed within 30 days prior to study entry. (Section 6.3.12 contains information about enrollment of and treatment selection for co-infected participants.)</p>\n </li>\n <li value=\"NaN\">\n <p>\n Agreement not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).</p>\n </li>\n</ol>\n<p style=\"margin-left: 80px;\">\n 4.1.8    Female candidates of reproductive potential must have a negative serum or urine (15-25 mIU/mL) pregnancy test result within 7 days prior to study entry.</p>\n<p style=\"margin-left: 80px;\">\n “Female candidates of reproductive potential” is defined as women who have reached menarche or who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy or salpingectomy).</p>\n<p style=\"margin-left: 80px;\">\n 4.1.9    Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, or hormone-based contraceptive) while receiving EFV, RIF, or other rifamycin, and for 6 weeks after stopping these drugs.</p>\n<ul>\n <li>\n <p>\n Female candidates who are not of reproductive potential, as defined above, or whose male partner(s) has undergone successful vasectomy with documented azoospermia or has documented azoospermia for any other reason, are eligible without requiring the use of contraceptives. Candidate-reported history is acceptable documentation of menopause, hysterectomy, or bilateral oophorectomy or salpingectomy.</p>\n </li>\n</ul>\n<p style=\"margin-left: 120px;\">\n NOTE: Written or oral documentation confirming lack of reproductive potential communicated by clinician or clinician’s staff of one of the following <strong>is</strong> required for participants receiving EFV: physician report/letter, discharge summary, FSH (follicle-stimulating hormone) measurement elevated into the menopausal range as established by the reporting laboratory. In addition, the participant’s own statement regarding her or her partner’s lack of reproductive potential must be recorded in the source documentation.</p>\n<p style=\"margin-left: 120px;\">\n If a female candidate reports infertility, as defined above, but does not have either written or oral documentation from a clinic or physician, or <strong>she </strong>states that her partner has had a vasectomy but documentation is unavailable, she must agree to use at least one barrier method of contraception with a possible second method to be required at the discretion of the site investigator.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.10  Karnofsky performance score ³30 at time of study entry.</p>\n<p style=\"margin-left: 80px;\">\n       </p>\n<p style=\"margin-left: 120px;\">\n            NOTE: As always, using best clinical judgment and all information available to them, site investigators retain the responsibility for determining whether patients who meet this criterion are appropriate candidates for this study.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.11  Males and females age ³13 years.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.12  Ability to swallow medications.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.13  Ability and willingness of participant or legal guardian/representative to provide informed consent.</p>\n<p style=\"margin-left: 80px;\">\n 4.1.14 Intention to remain in the same general geographic region for the duration of study participation (i.e., participant will be able to obtain transportation to the site throughout the study).</p>\n
      • principal_exclusion_criteria<p>\n Found in section 4.2 of the protocol</p>\n<h2>\n 4.2       Exclusion Criteria</h2>\n<ol>\n <li value=\"NaN\">\n Within 30 days prior to study entry and following completion of study-specific screening algorithm (see section 4.3.6), presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix, which is identified on the CRF.</li>\n <li value=\"NaN\">\n Use of single-dose NVP for prevention of mother-to-child transmission (pMTCT) within 24 months prior to study entry.</li>\n</ol>\n<p style=\"margin-left:108.0pt;\">\n NOTE: Combination antiretrovirals (ARVs) taken for any length of time during pregnancy for pMTCT is not exclusionary.</p>\n<ol start=\"3\">\n <li>\n Use of prohibited medications (see list in A5274/REMEMBER MOPS, section 3.2.1) within 30 days prior to study entry.</li>\n <li value=\"NaN\">\n Known allergy/sensitivity or any hypersensitivity to components of study-required ART or TB treatment.</li>\n <li value=\"NaN\">\n Current receipt of treatment for active TB or receipt of >14 days cumulative treatment for active TB within 96 weeks prior to study entry.</li>\n <li value=\"NaN\">\n Receipt of >30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.</li>\n</ol>\n<p style=\"margin-left:72.0pt;\">\n 4.2.7    Receipt at any time prior to study entry of >7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure).</p>\n<p style=\"margin-left:72.0pt;\">\n 4.2.8    Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.</p>\n<ol start=\"7\">\n <li>\n Current Grade ≥2 neuropathy.</li>\n <li value=\"NaN\">\n History of multi-drug-resistant (MDR) TB.</li>\n <li value=\"NaN\">\n Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.</li>\n</ol>\n
      • primary_end_points<p style=\"margin-left:36.0pt;\">\n Survival status at 24 weeks post randomization</p>\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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Abraham M. Siika MBChB, MMed, MS- Site Leader/ Principal Investigator</p>\n<p>\n  David Lagat - MBChB, MMed- Investigator</p>\n<p>\n Charles Kwobah, MBChB- Medical Officer</p>\n<p>\n Mercy Karoney  MBChB- Medical Officer</p>\n<p>\n Simon Wachira Njuguna, B Pharm, MPSK - Pharmacist of Record</p>\n<p>\n Kipruto Kirwa, BSc, MPH, PhD- Quality Manager</p>\n<p>\n Priscilla Cheruiyot, BScN, MPH- Site Coordinator</p>\n<p>\n Martha Mokaya, BSc, MBA- Data Manager</p>\n<p>\n Wilson Lokitala Ekiru, BSc IT- Assistant Data Manager</p>\n<p>\n Agnes M. Nzioka, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Betty Meli, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Michael Tanui, Dip Clin Med- Research Clinical Officer</p>\n<p>\n Julie Choge -  Recruitment Officer</p>\n<p>\n Amina Msuo Shali-  Recruitment Officer</p>\n<p>\n Dorothy Mwimali -  Recruitment Officer</p>\n<p>\n Cecilia Chebet, Dip Counselling - Recruitment Officer</p>\n<p>\n Beatrice Jakait, B Pharm- Back-up Pharmacist</p>\n<p>\n Zipporah Sambili, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n Chris Sande, KHRCN- Study Nurse</p>\n
      • other_details_explanation<table align=\"center\" cellpadding=\"0\" cellspacing=\"0\" hspace=\"0\" vspace=\"0\">\n <tbody>\n <tr>\n <td align=\"left\">\n <p style=\"margin-left:7.2pt;\">\n This study is being conducted in resource limited settings. Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area) of more than 100 cases/100,000 population per year, a national ART program, and documented high mortality rates among HIV-infected individuals (i.e., at least 5% overall at 6 months post ART initiation).</p>\n </td>\n </tr>\n </tbody>\n</table>\n<div style=\"clear:both;\">\n  </div>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n  Moi Teaching and Referral Hospital/Moi University Institutional Research and Ethics Committee (IREC). Continuing Approval granted on 14 June 2012 for Eldoret site only.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration96 weeks. Participants will transition to locally provided care and treatment at week 48.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorEFV-based ART (see sectio
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • 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_states11
      • number_of_sites2
      • multi_country_listKenya, India, Peru, South Africa, Malawi, Haiti, Brazil, Uganda, Zambia, Tanzania, Zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteInformation not immediately available
      • total_participants_worldwide836
      • 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_healthyNo
      • subjects_patientsYes
      • 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_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailamsiika@africaonline.co.ke
      • organisations_transferred_No
      • number_participants100 participants at the Eldoret site
      • notification
      • approval_date29-10-2010
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-08-2020
      • 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)
      • modified2020-08-10 11:42:35
      • created2013-05-22 16:28:51
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id85
        • application_id137
        • given_nameAbraham
        • middle_nameMosigisi
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP O Box, 4606-30100, Eldoret
        • telephone0721280785
        • emailamsiika@africaonline.co.ke
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
    • SiteDetail(array)
      • 0(array)
        • id106
        • application_id137
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressAMPATH at MTRH, Nandi Road, Eldoret
        • contact_details+254 53 2060850
        • contact_personAllan Sudoi
        • site_capacity(null)
        • misc(null)
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 1(array)
        • id108
        • application_id137
        • county_id35
        • site_nameWalter Reed Project
        • physical_addressKericho District Hospital
        • contact_details0713603225
        • contact_personHellen Ngeno
        • site_capacity(null)
        • misc(null)
        • created2013-05-31 09:42:50
        • modified2020-08-10 11:42:35
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id66
        • application_id137
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personMina C. Hosseinipour, M.D., M.P.H
        • addressKamuza Central Hospital, Tidziwe Centre, 100 Mzimba Road, Private Bag A-104, Lilongwe, MALAWI
        • telephone_number265 1 758 938
        • fax_number265 1 755 954
        • cell_number265 1 758 938
        • email_addressminach@med.unc.edu
        • created2013-05-22 17:01:26
        • modified2020-08-10 11:42:35
  • 3(array)
    • Application(array)
      • id136
      • user_id74
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background:</strong> Clindamycin plus quinine is recommended by World Health Organization as a non-artemisinin-based antimalarial drug combination. The evidence on the efficacy of clindamycin plus quinine compared with other antimalarial drugs is scanty, outdated and inconclusive. No studies have compared the efficacy of clindamycin plus quinine with that of artemether-lumefantrine in the treatment of participants with uncomplicated falciparum malaria.</p>\n<p>\n <strong>Objective:</strong> To evaluate the therapeutic efficacy and safety of oral clindamycin plus quinine vs. artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in children residing in an area of intense malaria transmission of western Kenya.</p>\n<p>\n <strong>Methods: </strong>An open-label randomised controlled clinical trial will be conducted at Ahero Sub-District Hospitals between September 2012 and June 2014. Study participants will be 384 children aged < 5 years with confirmed uncomplicated falciparum malaria. The participants will be randomised in a ratio of 1:1 to receive directly observed treatment with either clindamycin plus quinine or artemether-lumefantrine. Clinical and parasitological parameters will be monitored over 28 days follow up period to evaluate drug efficacy and safety.  The primary end-point will be the proportion of participants experiencing parasitological cure within 28 days of starting treatment. We will differentiate recrudescence from re-infections by analysis of MSP₁, MSP₂ and GLURP genes. Secondary end points will include fever resolution rates, parasite clearance rates, gametocyte carriage, change in mean haemoglobin (between day 0 and day 28), frequency of molecular markers of drug resistance and incidence of adverse events. This study will provide evidence that may be useful for informing the treatment policies for patients with uncomplicated <em>P. falciparum</em> malaria.</p>\n
      • study_title<p align=\"center\">\n An open-label randomized controlled trial of the efficacy and safety of Clindamycin plus quinine compared with artemether-lumefantrine for the treatment of children with uncomplicated  falciparum malaria in western Kenya</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/05/02
      • version_no1.2
      • date_of_protocol05-10-2012
      • study_drugCLINDAMYCIN PLUS QUININE
      • 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_nameClindamycin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresscobonyo65@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 Charles Owuora Obonyo
      • declaration_date129-05-2013
      • declaration_principal_investigatorDr Charles Owuora Obonyo
      • declaration_date229-05-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria for enrolment:</strong></p>\n<ol>\n <li>\n Age 6-59 months</li>\n <li>\n Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours</li>\n <li>\n Weight ≥ 5.0 kg</li>\n <li>\n Slide-confirmed infection with <em>P. falciparum</em></li>\n <li>\n Parasitaemia 2,000-200,000 asexual forms per <em>μl</em></li>\n <li>\n Parent/guardian provides informed consent</li>\n</ol>\n<p>\n  </p>\n<ul>\n <li>\n  </li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria for enrolment:</strong></p>\n<ol>\n <li>\n Presence of general danger signs or other signs of severe malaria and complicated falciparum malaria according to current WHO definitions [7]</li>\n <li>\n Mixed or mono-infection with another <em>Plasmodium </em>species</li>\n <li>\n Presence of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (NCHS/WHO normalized reference values)</li>\n <li>\n Known hypersensitivity to any of the drugs being tested</li>\n <li>\n Presence of febrile conditions caused by diseases other than malaria</li>\n <li>\n Presence of other serious or chronic medical conditions (heart failure, sickle cell disease).</li>\n <li>\n Plan to travel or leave the area within the next 1 month</li>\n <li>\n Inability to swallow oral medication</li>\n <li>\n Residence beyond 10km of the catchment area of the study hospital.</li>\n</ol>\n
      • primary_end_points<p>\n Proportion of children experiencing clinical and parasitological cure by day 28 after receiving study treatment</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • 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<p>\n <font face=\"Helvetica\">Dr Kevin Omondi Bachelor of Medicine and Bachelor of Surgery.3 years clinical trial </font><font face=\"Helvetica\">research experience. GCP/GCLP certified</font></p>\n<p>\n <font face=\"Helvetica\">Mr Julian KE Omondi Diploma in Clinical medicine. 3 years trial experience. GCP certified</font></p>\n<p>\n <font face=\"Helvetica\">Ms Nelly Koskei Diploma in Community Health Nursing. 3 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Mr Kevin Magare Diploma in Community Health Nursing. 2 years clinical trial research </font><font face=\"Helvetica\">experience. GCP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Mr Wycliffe Misiayi Diploma in Community Health Nursing. 2 years clinical trial research </font><font face=\"Helvetica\">experience. GCP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Grace Owino Diploma in Medical Laboratory Technology. 3 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Festus Okute Certificate in Medical Laboratory Technology. 15 years clinical trial research </font><font face=\"Helvetica\">experience. GCP/GCLP certified.</font></p>\n<p>\n <font face=\"Helvetica\">Erick Otiu Diploma in Computer and systems engineering. 2 years clinical trial  </font><font face=\"Helvetica\">research experience. GCP certified</font></p>\n
      • other_details_explanation<p>\n The study will be done in Kenya and is also sponsored by KEMRI, which is the Kenyan Medical Research Institute. </p>\n
      • other_details_regulatory_notapproved<p>\n NIL</p>\n
      • other_details_regulatory_approved<p>\n The KEMRI Ethics Committee reviewed the protocol of this study and approved it on 10th October 2012</p>\n
      • other_details_regulatory_rejected<p>\n NIL</p>\n
      • other_details_regulatory_halted<p>\n Not applicable, as the trial has not yet started.</p>\n
      • estimated_duration24 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-lumefantrine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAhero Sub-district Hospital
      • single_site_physical_addressAlong Kericho to Kisumu Highway
      • single_site_contact_personDr Kevin Omondi
      • single_site_telephone+254 722740654
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site384
      • total_participants_worldwide384
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifychildren between 6 to 59 months of age
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameCHARLES
      • investigator1_middle_nameOWUORA
      • investigator1_family_nameOBONYO
      • investigator1_qualificationPhD
      • investigator1_professional_addressKenya Medical Research Institute, P.O. Box 1578, KISUMU, KENYA
      • investigator1_telephone+254 724993118
      • investigator1_emailcobonyo65@yahoo.com
      • organisations_transferred_Yes
      • number_participants384
      • notification
      • approval_date10-10-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-06-2013
      • 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)
      • modified2013-10-07 09:54:33
      • created2013-05-22 12:44:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id84
        • application_id136
        • given_nameCHARLES
        • middle_nameOWUORA
        • family_nameOBONYO
        • qualificationPhD
        • professional_addressKenya Medical Research Institute, P.O. Box 1578, KISUMU, KENYA
        • telephone+254 724993118
        • emailcobonyo65@yahoo.com
        • created2013-05-22 15:57:05
        • modified2013-06-03 13:59:00
    • SiteDetail(array)
      • 0(array)
        • id105
        • application_id136
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-05-22 15:57:05
        • modified2013-06-03 13:59:00
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id65
        • application_id136
        • sponsorKenya Medical Research Institute
        • sponsor_type(null)
        • contact_personDr John Vulule
        • addressP.O. Box 1578, KISUMU, KENYA
        • telephone_number+254 57 22924
        • fax_number
        • cell_number+254 722679547
        • email_addressjvulule@kemri.org
        • created2013-05-22 15:57:05
        • modified2013-06-03 13:59:00
  • 4(array)
    • Application(array)
      • id135
      • user_id75
      • trial_status_id(null)
      • abstract_of_study<p>\n Malaria is one of the largest global health problems. As per the World Health Organization (WHO), in 2008 there were an estimated 243 million cases and 863,000 malaria-related deaths. Malaria in pregnancy (MIP) is one of the most common causes of preventable mortality and morbidity in pregnant women and infants in sub-Saharan Africa with an estimated 30 million pregnancies at risk each year; resulting in about 200,000 infants and 10,000 women deaths annually.</p>\n<p>\n  </p>\n<p>\n MIP is associated with suboptimal pregnancy outcomes including low birth-weight (LBW) neonates, still births and miscarriages. LBW is the most predictive risk factor for neonatal mortality in sub-Saharan Africa. Thus reducing the incidence of LBW has broad public health implications. Important progress has been made in the control of MIP with the introduction of intermittent preventive treatment for malaria in pregnancy (IPTp). The WHO recommends IPTp during antenatal visits in high malaria transmission areas of sub-Saharan Africa. However, widespread sulfadoxine-pyrimethamine (SP) resistance especially in East and Southern Africa greatly limits the protective effect of IPTp. The development of safe, efficacious and affordable replacement of SP for IPTp is therefore an urgent priority.</p>\n<p>\n  </p>\n<p>\n The combination of azithromycin (AZ) and chloroquine (CQ) could potentially replace</p>\n<p>\n SP for IPTp. AZ and CQ are synergistic against CQ resistant strains of <em>P. falciparum and their co</em>-administration has demonstrated efficacy, safety and tolerability in Phase 3 clinical studies in the treatment of malaria in non-pregnant adults in sub-Saharan Africa. In addition, AZ and CQ have been on the market for several years and have extensive safety records in adults, children and pregnant women. Both drugs have also been widely used in all trimesters of pregnancy and are considered safe in pregnant women as individual agents.</p>\n<p>\n  </p>\n<p>\n A fixed dose combination tablet formulation of AZ and CQ has been developed for IPTp and will be evaluated in this study. The study is a Phase 3 clinical trial aimed at demonstrating superiority of AZCQ over SP, the current standard of care for IPTp indication. It will be conducted primarily in East and Southern Africa where SP resistance is evident. The study will enroll asymptomatic pregnant participants during second trimester of pregnancy. This will be the pivotal study for regulatory submissions to European Medicines Agency (EMA) and to the national regulatory agencies in sub-Saharan African countries.</p>\n
      • study_title<p>\n A Phase 3, Open Label, Randomized, Comparative Study to Evaluate Azithromycin Plus Chloroquine and Sulfadoxine Plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Malaria Infection in Pregnant Women in Africa. WRAIR #1775, KEMRI SSC #1983</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/11/10/05
      • version_noFinal Protocol
      • date_of_protocol14-02-2010
      • study_drugcombination of azithromycin (AZ) and chloroquine (CQ)
      • disease_conditionMalaria in Pregnacy
      • 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_nameAZ-CQ
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvkowira@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_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • 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_applicant0722299438
      • declaration_date123-05-2013
      • declaration_principal_investigatorDr Lucas Otieno
      • declaration_date223-05-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">1. Pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (defined by</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">ultrasound).</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">2. Evidence of a personally signed and dated informed consent document indicating that the</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">subject (or a legally acceptable representative if a subject is <18 years of age) has been</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">informed of all pertinent aspects of the study and that all questions by the subject have</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">been sufficiently answered. Assent will be obtained from subjects <18 years of age.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">3. Subjects who are willing and able to comply with scheduled visits, treatment plan,</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">laboratory tests, and other study procedures.</font></p>\n<p align=\"LEFT\">\n  </p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">4. Subjects who agree to be supervised for treatment administration, and are available for all</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">follow up visits as per protocol, including follow ups at delivery and on 28 days post</font></p>\n<p>\n <font face=\"TimesNewRoman\" lang=\"JA\">delivery.</font></p>\n
      • principal_exclusion_criteria<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">1. Age <16 years old or >35 years old.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">2. Multiple gestations (more than one fetus) as per the ultrasound results at screening.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">3. Clinical symptoms of malaria.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">4. Hemoglobin < 8 g/dL (measured at baseline).</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">5. Any condition requiring hospitalization or evidence of severe concomitant infection at</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">time of presentation.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">6. Use of antimalarial drugs in previous 4 weeks.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">7. History of convulsions, hypertension, diabetes or any other chronic illness that may</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">adversely affect fetal growth and viability.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">8. Inability to tolerate oral treatment in tablet form.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">9. Known allergy to the study drugs (AZ, CQ, and SP) or to any macrolides or</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">sulphonamides.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">10. Present history of smoking or alcohol or drug abuse since first becoming aware of current</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">pregnancy.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">11. Participation in other studies within 30 days before the current study begins and/or during</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">study participation.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">12. Inability to comprehend and/or unwillingness to follow the study protocol.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">13. Concurrent participation in another investigational study.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">14. Previously randomized in this study.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">15. Requirement to use medication during the study that might interfere with the evaluation</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">of the study drug (eg, trimethoprim-sulfamethoxazole use in subjects positive for HIV</font></p>\n<p>\n <font face=\"TimesNewRoman\" lang=\"JA\">infection) or is contra-indicated during pregnancy per package inserts.</font></p>\n<p>\n  </p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">16. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">may increase the risk associated with study participation or investigational product</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">administration or may interfere with the interpretation of study results and, in the</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">judgment of the investigator, would make the subject inappropriate for entry into this</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">study. Examples would include but not limited to:</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">a. Symptomatic HIV infection, including physical findings that suggest</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">immunocompromised status (eg, oral candidiasis);</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">b. Neurological conditions which may predispose to complications during</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">pregnancy, including seizure disorders;</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">c. Severe psychosis or major disorder that may interfere with the conduct of the</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">study or adherence to study medication;</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">d. Known, clinically significant pre-existing renal or hepatic disease.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">17. Evidence of current obstetric complications that may adversely impact the pregnancy</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">and/or fetal outcomes, including presence of congenital anomalies, placenta previa or</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">abruption.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">18. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">19. Known family history of prolonged QT Syndrome, serious ventricular arrhythmia, or</font></p>\n<p>\n <font face=\"TimesNewRoman\" lang=\"JA\">sudden cardiac death.</font></p>\n
      • primary_end_points<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">Primary Efficacy Endpoint</font></p>\n<p align=\"LEFT\">\n <font face=\"Symbol\" lang=\"ZH-TW\">ï‚· </font><font face=\"TimesNewRoman\" lang=\"JA\">Presence of subjects with a sub-optimal pregnancy outcome defined as any of the</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">following: live-borne neonate (singleton) with low birth-weight (or LBW for short,</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">defined as live birth weight <2,500g), premature births (<37 weeks), abortion</font></p>\n<p align=\"LEFT\">\n <font face=\"TimesNewRoman\" lang=\"JA\">(≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of</font></p>\n<p>\n <font face=\"TimesNewRoman\" lang=\"JA\">pregnancy or delivery, or missing birth weight of the neonates.</font></p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • 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<p>\n 3 physicians, 10 nurses, 6 clinical officers</p>\n
      • other_details_explanation<p>\n The disease under investigation is not a burden in the host country of the sponsor</p>\n
      • other_details_regulatory_notapproved<p>\n none</p>\n
      • other_details_regulatory_approved<p>\n European Medicines Agency</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration3 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorFansidar
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites2
      • multi_country_listKenya, Mali,\nGhana, Burkina Faos and Cote d’voire
      • data_monitoring_committeeYes
      • total_enrolment_per_site800
      • total_participants_worldwide5044
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • 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_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB, Mped, PhD
      • investigator1_professional_address54-40100 Kisumu
      • investigator1_telephone0733812613
      • investigator1_emailbernhards.ogutu@usamru-k.org
      • organisations_transferred_Yes
      • number_participants1600
      • notification<p>\n none</p>\n
      • approval_date25-11-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-05-2013
      • 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)
      • modified2013-05-24 16:28:24
      • created2013-05-22 12:30:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id86
        • application_id135
        • given_nameLucas
        • middle_nameOtieno
        • family_nameTina
        • qualificationMBChB, MPH
        • professional_address54-40100 Kisumu
        • telephone0720597654
        • emailLucas.Tina@usamru-k.org
        • created2013-05-22 18:22:30
        • modified2013-05-23 09:10:24
    • SiteDetail(array)
      • 0(array)
        • id107
        • application_id135
        • county_id42
        • site_nameKEMRI/WRP Kombewa
        • physical_addressKombewa Clinical Research Center off kisumu bondo road, opposite Kombewa District Hospital
        • contact_details0733333530, PO Box 54-40100 Kisumu
        • contact_personDr Lucas Otieno
        • site_capacity(null)
        • misc(null)
        • created2013-05-22 18:22:30
        • modified2013-05-23 09:10:24
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id67
        • application_id135
        • sponsorPfizer
        • sponsor_type(null)
        • contact_personThanyani, Nathaniel Ramuthaga
        • addresspfizer laboratories (pty) ltd,95 Bute Lane, Sandton, 2196, PO Box 783720, Sandton, 2146
        • telephone_number+27118951500
        • fax_number+27118951500
        • cell_number+27118951500
        • email_addressNonkululeko.Dlamini@parexel.com
        • created2013-05-22 18:22:30
        • modified2013-05-23 09:10:24
• 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

App Constants

CakePHP Constants

PHP Environment

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