Request History

• Restore to current request
• applications/index/sort:study_title/direction:desc/approved:2/page:6
• applications/index/sort:study_title/direction:desc/approved:2/page:7
• applications/index/sort:study_title/direction:desc/approved:2/page:4
• applications/index/sort:study_title/direction:desc/approved:2/page:5

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746044355
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • sortstudy_title
  • directiondesc
  • approved2
  • page9
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page9
    • current5
    • count501
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page9
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • directiondesc
    • paramTypenamed

Post data

• Application(array)
  • approved2

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id474
      • user_id321
      • trial_status_id7
      • abstract_of_study<div style=\"width: 80%\">\n <div style=\"font-size: 12px; width: 698.391px;\">\n <p style=\"margin-left: 1.5in;\">\n  </p>\n </div>\n</div>\n<p class=\"Normal1\" style=\"text-align:justify\">\n <strong>Purpose:</strong><b> </b>To determine whether isoniazid (INH) reduces the risk of <i>Mycobacterium tuberculosis</i> (MTB) infection in HIV-exposed but uninfected (HEU) children. To determine the epidemiologic and immunologic correlates of MTB infection in HEU.<o:p></o:p></p>\n<p>\n <strong>Study Population: </strong>HIV-exposed uninfected (HEU) infants and their mothers</p>\n<p>\n <strong>Study Size: </strong>300 infants, 150 per arm </p>\n<p>\n <strong>Treatment Regimen:</strong> Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months. </p>\n<p>\n <strong>Study Duration:</strong> 3 years (12 months of follow-up for each participant)</p>\n<p>\n <strong>Primary Objectives:</strong></p>\n<p>\n AIM: 1 Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an IGRA assay to determine MTB infection status.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p>\n AIM 2: Determine epidemiologic correlates of MTB infection among infants enrolled in the RCT.</p>\n<p>\n AIM 3: Determine immune correlates of risk of primary MTB infection and their potential interactions with INH. Assays will include infant peripheral blood BCG-specific T-cell responses at approximately 6 weeks post BCG vaccination, and maternal breast milk MTB-specific T-cell responses at approximately 6 weeks postpartum.</p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n Investigate the impact of IPT on a combined endpoint of MTB infection, TB disease, and death among HEU infants</p>\n<p>\n <strong>Study Sites:                </strong>Maternal Child Health (MCH) clinics in Western Kenya (Kisumu, Ahero and Bondo).</p>\n
      • study_title<p>\n Preventing <em>Mycobacterium Tuberculosis</em> Infection in HIV-Exposed Infants</p>\n<p align=\"center\">\n  </p>\n
      • laymans_summary(null)
      • short_titleInfant TB Infection Prevention Study (“iTIPS”)
      • protocol_noECCT/16/03/02
      • version_no1.0
      • date_of_protocol06-08-2015
      • study_drugisoniazid
      • disease_conditionMycobacterium tuberculosis infection
      • 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_nameisoniazid
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssmlacourse@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_countries0
      • 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_applicantJohn Kinuthia
      • declaration_date125-01-2016
      • declaration_principal_investigatorGrace John-Stewart
      • declaration_date225-01-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n HIV-exposed uninfected infants who meet all of the following criteria are eligible for inclusion in this study:</p>\n<p style=\"margin-left:.5in;\">\n ●            Aged 6 weeks within (+/- 4 weeks)</p>\n<p style=\"margin-left:.5in;\">\n ●            Born to HIV-infected mothers</p>\n<p style=\"margin-left:.5in;\">\n ●            Not premature and over 2.5 kg</p>\n
      • principal_exclusion_criteria<p>\n HIV-exposed uninfected infants who meet any of the following criteria will be excluded from this study:</p>\n<p style=\"margin-left:.5in;\">\n ●            Infants with known exposure to active TB in household at time of enrollment</p>\n<p style=\"margin-left:.5in;\">\n ●            Premature and < 2.5 kg</p>\n
      • primary_end_points<p style=\"margin-left:.25in;\">\n Mycobacterium tuberculosis infection as detected by interferon gamma release assays (IGRA) at 12 months post-enrollment. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • 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 The facilities are County teaching and Referral Hospitals, which are equipped to manage emergencies with the below listed Qualified and licensed professionals involved directly to the iTIPS Study.</p>\n<p>\n 1 study coordinator</p>\n<p>\n 1 nurse with pediatric phlebotomy experience</p>\n<p>\n 1 retention counselor</p>\n<p>\n We will plan on enrolling primarily at Kisumu County Hospital, and will only enroll at Ahero and Bondo sites if there are issues with timely enrollment at Kisumu County Hospital.</p>\n
      • other_details_explanation<p>\n Children living with HIV-infected household members are at increased risk of TB exposure.Among children, accelerated progression from latent TB infection to active TB disease is associated with immunosuppression and younger age.<span style=\"font-size: 10px;\"> </span>Kenya is one of 22 high TB burden countries with a generalized TB epidemic affecting young adults. A large observational study from AMPATH in Western Kenya longitudinally estimated TB disease incidence in HIV-infected children and noted a staggeringly high 17.1% annual incidence of active TB in a cohort with a median age of 1.0 year at enrollment.<span style=\"font-size: 10px;\"> </span>TB disease prevalence was also high at 3.6% on enrollment. </p>\n<p>\n This study is designed to determine if isoniazid reduces the risk of Mycobacterium tuberculosis infection in HIV-exposed uninfected infants. In order to answer this question, this trial must be conducted in a high HIV/TB burden area.</p>\n<p>\n This study leverages pre-existing research team experience and infrastructure in western Kenya. University of Washington and Kenyan researchers have worked collaboratively on epidemiologic and immunologic studies examining HIV and co-infections in maternal-infant cohorts for >25 years.  </p>\n
      • other_details_regulatory_notapproved<p>\n N/A. Â We have approval from the UON-KNH ERC and University of Washington IRB.</p>\n
      • other_details_regulatory_approved<p>\n We have approval from the UON-KNH ERC 13Jan2016 - 12Jan2017.</p>\n<p>\n  </p>\n<p>\n We have approval from the University of Washington IRB 12Jan2016 - 11Jan2017. </p>\n
      • other_details_regulatory_rejected<p>\n N/A. We have had no rejections.</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years (12 months of follow-up for each participant)
      • 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_comparatorno INH (non-blinded, non-
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifypyroxidine will be given to children randomized to isoniazid
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThere is no set enrollment at each site.
      • total_participants_worldwide300 (150 infants in each arm)
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyHIV-exposed uninfected infants aged 6 weeks will be enrolled.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJohn
      • investigator1_middle_name
      • investigator1_family_nameKinuthia
      • investigator1_qualificationMBChB, MMed, MPH
      • investigator1_professional_addressHead, Research and Programs Kenyatta National Hospital PO Box 20723, Nairobi, Kenya
      • investigator1_telephone+254-722-799-052
      • investigator1_emailkinuthia@u.washington.edu
      • organisations_transferred_No
      • number_participants300 (150 infants in each arm)
      • notification
      • approval_date03-06-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-03-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Primary outcome assessment occurred at 12 months post-randomization. Excluding the 2 children who were found to be HIV-infected, 287 infants completed the study. 264 of the 287 infants who exited the study have QFT results and/or TST results available. QFT results are available for 246 infants, of which 240 are negative (125 INH, 115 No INH), 3 indeterminate (3 INH, 0 No INH), and 3 (1.2%) positive (2 INH, 1 No INH). TST testing was initiated 26 Feb 2018, and was performed on 187 children, of which 134 were <5 mm (72 INH, 62 No INH), 28 5-<10 mm (13 INH, 15 No INH), 21 10-<15 mm (7 INH, 14 No INH), and 4 15-19 (1 INH, 3 No INH) mm. Using a 10 mm cut-off, 25 (13.4%) children are TST+ (8 INH, 17 No INH). One infant was clinically diagnosed with TB by MOH clinical staff with clinical features compatible with TB including failure to thrive, abnormal CXR, and improvement of symptoms after TB treatment was initiated in the INH arm. The prevalence of MTB infection by QFT or TST (<u>></u> 10 mm) among children with either or both results is 10.6% (28/263).</p>\n<p>\n In a modified intention to treat analysis excluding the 2 children who were diagnosed with HIV, the prevalence of MTB infection (by TST or QFT) was approximately 2-fold lower in the INH group compared to the No INH group, though not statistically significant (INH: 10/131 (7.6%) vs. No INH: 18/133 (13.5%), RR 0.56 (95% CI 0.27-1.18), p=0.13). This trend for reduced prevalence of MTB infection in the INH vs. No INH arm was stronger when evaluating TST-positivity alone (8.6% versus 18.1%, p=0.07).</p>\n<p>\n Similarly, there was a trend for lower cumulative incidence of MTB infection in the in the INH group compared to the No INH group (7.0 vs 13.5 per 100 person years, HR 0.54 (95% CI 0.25-1.16), p=0.114). Analyses of a composite endpoint of MTB infection, death, or TB were also similar and driven primarily by MTB infection.</p>\n<p>\n In per protocol analyses, further excluding 5 infants in INH arm who never received INH dose, and 1 infant in No INH arm who initiated INH due to TB exposure resulted in similar results to the modified intention to treat analyses.</p>\n<p>\n In summary, isoniazid appears to reduce the risk of primary MTB infection in HIV-exposed uninfected children. The final primary endpoint results do not meet statistical significance, however there is a strong trend for these findings. We ask that these results not be widely shared while they are still preliminary.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-04-24 23:58:10
      • created2016-01-25 09:30:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id312
        • application_id474
        • given_nameGrace
        • middle_name
        • family_nameJohn-Stewart
        • qualificationMD, PhD
        • professional_address325 9th Avenue, Box 359909 Seattle, WA 98104 USA
        • telephone+1-206-543-4278
        • emailgjohn@u.washington.edu
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
    • SiteDetail(array)
      • 0(array)
        • id371
        • application_id474
        • county_id42
        • site_nameKisumu East District Hospital
        • physical_addressOpposite Kisumu Sports Ground, Paul Mbuya Rd, Kisumu, Kenya
        • contact_details P.O Box 1818
        • contact_personDr Amos Otedo
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id372
        • application_id474
        • county_id42
        • site_nameAhero County Hospital
        • physical_address69 off Nairobi Kericho High way Rd (Near Nyando River )
        • contact_details P. O .Box 169-40101
        • contact_personDr. Joram Ouma
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 12:09:02
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id373
        • application_id474
        • county_id42
        • site_nameBondo sub-County Hospital
        • physical_address89 off Bondo Siaya Rd next to police station
        • contact_detailsP.O. Box 89
        • contact_personDr. Felix Tidi
        • site_capacity(null)
        • misc(null)
        • created2016-01-25 12:11:23
        • modified2016-03-12 03:15:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id245
        • application_id474
        • sponsorThrasher Research Fund
        • sponsor_type(null)
        • contact_personAllison F. Martinez
        • addressThrasher Research Fund 68 S. Main St., Suite 400 Salt Lake City, UT 84101, USA
        • telephone_number+1-801-240-4753
        • fax_number+1-801-240-1625
        • cell_number+1-801-240-4753
        • email_addressMartinezAF@Thrasherresearch.org
        • created2016-01-25 09:40:07
        • modified2016-03-12 03:15:23
  • 1(array)
    • Application(array)
      • id832
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Sub-Saharan Africa has a high rate of new HIV infections. Each year, over two million people are reported to be newly infected, the majority of whom are young African women (under age 30). Women account for more than half of the new infections in Africa. They also face a disproportionate burden of sexually transmitted infections (STIs). The consequences of bacterial STIs on sexual and reproductive health can be profound. This study seeks to evaluate the effectiveness of doxycycline post-exposure prophylaxis (dPEP) to reduce STIs in HIV-uninfected women aged 18 – 30 years who are taking HIV pre-exposure prophylaxis (PrEP) in Kisumu, Kenya. The study aims to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP We will conduct an open-label randomized trial of dPEP versus standard of care among 446 women taking PrEP and follow them for 12 months. We will employ a mixed methods research approach, including use of quantitative questionnaires, focus group discussions (FGDs), short message service (SMS) and individual indepth interviews (IDIs) to study acceptability and changes in sexual behavior due to dPEP. We will collect data specific to women to evaluate if dPEP is effective, safe, acceptable, tetracycline resistance inducing, and cost effective to inform public health policy.</p>\n
      • study_title<p>\n PrEP and dPEP: Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis</p>\n
      • laymans_summary<p>\n In recent times, young women in Africa are twice as likely to acquire a new HIV infection compared to their male counterparts. They are also more affected with multiple health risks from common sexually transmitted infections like gonorrhea, chlamydia and syphilis which are all preventable and treatable. PrEP is known to prevent HIV when taken as prescribed. Past research has also shown that doxycline medication can treat STIs like chlamydia, syphilis and gonorrhea. We would therefore like to find out whether using dPEP among young Kenyan women already taking PrEP will reduce disease burden in this group. We will carry out an investigation to compare one group taking dPEP with another group receiving standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 women taking PrEP (1:1 allocation, 223 per group). We will target women from ages 18 to 30 years old and the study will take place in Lumumba and Jaramogi, Oginga Odinga Teaching and Referral Hospital. We will follow up the women for 12 months. The study will aim to assess whether dPEP is acceptable, safe, and tolerable by understanding challenges and motivators of dPEP use and adherence to dPEP and PrEP. Additionally we will evaluate the cost and impact of using dPEP in controlling new infections and complications. We will carry out indepth interviews, focus group discussions with women on PrEP and also ask them questions to understand their study acceptability and changes in their sexual behavior due to dPEP</p>\n
      • short_titlePrEP and dPEP
      • protocol_noECCT/19/11/02
      • version_no2.0
      • date_of_protocol24-09-2019
      • study_drugDoxycycline capsules
      • disease_conditionSexually Transmitted Infections
      • 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_nameDoxycycline hyclate 100mg
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.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_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_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantP.O BOX 614-40100
      • declaration_date111-11-2019
      • declaration_principal_investigatorPrincipal Investigator
      • declaration_date211-11-2019
      • placebo_presentNo
      • study_objectives<p>\n 1. Evaluate the effectiveness of doxycycline post-exposure prophylaxis (PEP) to reduce STI infections in HIV-uninfected Kenyan women taking HIV PrEP</p>\n<p>\n 2. Assess the safety, tolerability, and acceptability of dPEP</p>\n<p>\n 3. Assess adherence to dPEP</p>\n<p>\n 4. Investigate the impact of dPEP on tetracycline resistance in N. gonorrhoeae and C. trachomatis</p>\n<p>\n 5. Measure the cost of dPEP and estimate the cost per case averted, budget impact, and affordability.</p>\n
      • principal_inclusion_criteria<p>\n Inclusion criteria 1) Willing and able to give written informed consent 2) Age ≥18 years and 30 years old 3) Female sex at birth 4) HIV-seronegative, according to national HIV testing algorithm 5) Has a current prescription for PrEP according to the national guidelines of Kenya.</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria 1) Pregnant 2) Breastfeeding a child 3) Allergy to tetracycline class 4) Current medications which may impact doxycycline metabolism or that are contraindicated with doxycycline, as per the prescribing information. These include systemic retinoids, barbiturates, carbamazepine, phenytoin, and warfarin. 5) Recent use of prolonged (more than 14 day course) antibiotics in the month prior to enrollment 6) Active, clinically significant medical or psychiatric conditions that would interfere with study participation, at the discretion of the site investigator or designee.</p>\n
      • primary_end_points<p>\n Primary Analysis: We will analyze the composite endpoint of any of the three STIs as well as for C. trachomatis alone, and we will continue until there are sufficient C. trachomatis events (n=66) given the high incidence of this pathogen and its importance for reproductive morbidity (the consequence of which will be that the total number of events in the composite of C. trachomatis, N. gonorrhoeae, and syphilis will be greater than n=66). Analyses will be intention-to-treat, including women whether or not they continue dPEP (as well as whether or not they continue PrEP). STI incidence will be compared between arms using repeated measures analysis of proportions (e.g., generalized estimating equations [GEE]), given possibility of repeat infection within individuals. Per-protocol and adjusted analyses will be done as needed, controlling for potential confounders: demographics (e.g., age, education), sexual behavior (e.g., condom use, # partnerships), and beliefs (e.g., risk perception, dPEP/PrEP efficacy). SAS or R will be used.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • 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_other1
      • trial_other_specifyopen-label randomized trial of dPEP versus standard of care
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Receptionist 1-Diploma in secretarial studies</p>\n<p>\n Study nurses-2- Diploma in Nursing</p>\n<p>\n Study Clinicians-2- Diploma in Clinical medcine</p>\n<p>\n Pharmaceutical Technologists-2- Dploma in Phrmaceuticl Technology</p>\n<p>\n Pharmacist- 1- B.Pharm</p>\n<p>\n Community liason officer-1- Bachelors in Community Health</p>\n<p>\n Research Assistants-2- Diploma in Community Health</p>\n<p>\n Data Mangaer-1- BSc Statistics</p>\n<p>\n Data Clerks-1- Diploma in Statistics</p>\n<p>\n Medical Laboratory Technologist-1- Diploma in Medical laboratory</p>\n<p>\n Administrator-1- BBM</p>\n<p>\n HRM-1- Human resources management</p>\n<p>\n Study coordinator-1-</p>\n<p>\n Co-Investigators-2-</p>\n<p>\n Principal Investigator-1</p>\n
      • other_details_explanation<p>\n The trial will be conducted in Kenya not in the host country.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Unit 23rd October 2019</p>\n<p>\n University of Washington IRB 07 November 2019</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration5 years
      • 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_comparatorNone Doxycycline capsules
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CMR/RCTP Kisumu-Lumumba Sub-County Hospital
      • single_site_physical_addressP.O BOX 614-40100
      • single_site_contact_personProfessor Elizabet Bukusi
      • single_site_telephone0733 617 503
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site446
      • total_participants_worldwide446
      • 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_male0
      • 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_nameDr.Elizabeth Bukusi
      • investigator1_middle_nameAnn
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressP.O Box 614-40100
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants446
      • notification<p>\n We have requested for an invoice from PPB to facilitate the payment of application fee.</p>\n<p>\n Once we have received the invoice, we will proceed to make the payment promptly.</p>\n<p>\n Thank you,</p>\n<p>\n Eric,</p>\n<p>\n  </p>\n
      • approval_date31-01-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-06-2020
      • 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)
      • modified2025-03-18 11:54:30
      • created2019-11-11 14:03:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id514
        • application_id832
        • given_nameDr.Elizabeth Bukusi
        • middle_nameAnn
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressP.O Box 614-40100
        • telephone0733617503
        • emailebukusi@rctp.or.ke
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
    • SiteDetail(array)
      • 0(array)
        • id673
        • application_id832
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id402
        • application_id832
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personJared Beaten
        • addressUniversity of Washington, Seattle, WA
        • telephone_number001 206-520-3808
        • fax_number
        • cell_number001 206-520-3808
        • email_addressjbaeten@uw.edu
        • created2019-11-11 14:09:20
        • modified2020-06-17 11:29:13
  • 2(array)
    • Application(array)
      • id286
      • user_id172
      • trial_status_id6
      • abstract_of_study<h1>\n Summary</h1>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Design:                       </strong>Randomized clinical trial involving hospitalized HIV-1 infected children.  Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days).  This trial will be unblinded.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Population:                </strong>Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Sample size:              </strong>360 children will be randomized (180 per arm). </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Treatment:                 </strong>All children will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.   </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study duration:         </strong>Enrollment into the study will occur over the course of 36-48 months and each child will be routinely followed for a maximum of 6 months.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study sites:</strong>               Kenyatta National Hospital, Kisumu District Hospital, Nyanza Provincial Hospital)</p>\n
      • study_title<p>\n POST STABILIZATION VERSUS URGENT START OF HAART IN HIV-1 INFECTED CHILDREN WITH SEVERE COINFECTION</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/07/01
      • version_noVERSION 3.0
      • date_of_protocol01-08-2012
      • study_drugANTIRETROVIRALS
      • disease_conditionHIV
      • 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_nameANTIRETROVIRALS
      • product_type_medical_device_nameN/A
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmoraahelen@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 Dalton Wamalwa
      • declaration_date126-06-2014
      • declaration_principal_investigatorDr Dalton Wamalwa
      • declaration_date226-06-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion Criteria</p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Aged ≤ 12 years old (reported)</li>\n <li>\n HIV-1 positive (for example, two rapid HIV-1 antibody tests for children >18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)</li>\n <li>\n No prior ART (history of pMTCT antiretroviral treatment does not affect eligibility)</li>\n <li>\n Eligible to receive ART, according to current WHO guidelines</li>\n <li>\n Caregiver plans to reside in study catchment area for at least 6 months (reported)</li>\n <li>\n Caregiver provides sufficient locator information</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria:Â Suspected central nervous system infection (meningitis, encephalitis or other)</p>\n
      • primary_end_points<p>\n IRIS</p>\n<p>\n All cause mortality</p>\n<p>\n Drug toxicity</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Grace John-Stewart, BS, MD, MPH, PhD - Principal Investigator<br />\n Dalton Wamalwa, MBChB, MMed (Paeds), MPH - Site Principal Investigator<br />\n Lisa Ann Mills MD , MS - Co-Investigator<br />\n Jennifer Ann Slyker - Co-Investigator<br />\n Irene Njuguna, MBChB, MSc - Study Physician<br />\n Lisa M Cranmer, BS, MD, MPH - Study Physician<br />\n Vincent Otieno, MBChB - Study Physician<br />\n Daisy Jelagat Chebet, Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Judith Adhiambo, Dip. Clinical Medicine and Surgery, BA Soc and Psych - Clinical Officer<br />\n Benard Agony Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Helen Moraa, BSN - Study Coordinator<br />\n Clement Eweh Zeh - Laboratory Director<br />\n Esther Isarwa, KRN, - Study Nurse<br />\n Petronilla Wambulwa, KECN - Study Nurse<br />\n Sarah Njoki Mwangi - Recruitment Nurse<br />\n Beatrice Walimbwa, Cert in Med Lab - Technician Clinic Assistant/Phlebotomy<br />\n Simon Wahome, BPharm - Pharmacist<br />\n Nypha Mmayi , Pharm - Back up Pharmacist<br />\n Brian Muhanji - Lab Technologist<br />\n John Gatimu - Lab Technologist<br />\n Jackline Ouma - Pharmaceutical Technologist<br />\n Suzan Atinga - Nurse Counselor<br />\n Millicent Okongo - Nurse Counselor</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KNH/UoN Ethics and Research Committee - date of approval, 16th February 2013</p>\n<p>\n UNIVERSITY OF WASHINGTON IRB -Â 17th May 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3.5 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_comparatorURGENT ART (48 HOURS), EA
      • 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_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site120 - Kenyatta National Hospital\n120 - Kisumu District Hospital\n120 - Jaramogi Oginga Odinga Teaching and Referral Hospital
      • total_participants_worldwide360
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • 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
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDalton
      • investigator1_middle_name
      • investigator1_family_nameWamalwa
      • investigator1_qualificationMmed, MPH Epidemiology
      • investigator1_professional_address19676 -00202
      • investigator1_telephone020- 273-1498
      • investigator1_emaildalton@africaonline.co.ke
      • organisations_transferred_Yes
      • number_participants360
      • notification
      • approval_date21-10-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-07-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2015-09-04 11:01:23
      • created2014-03-24 10:33:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id199
        • application_id286
        • given_nameGrace
        • middle_name
        • family_nameJohn-Stewart
        • qualificationPhD
        • professional_address325-Ninth Ave, Box 359909, Seattle WA, 98104 USA
        • telephone+1- 206-543-4278
        • emailgjohn@uw.edu
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
    • SiteDetail(array)
      • 0(array)
        • id245
        • application_id286
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressKenyatta National Hospital Grounds
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id246
        • application_id286
        • county_id42
        • site_nameJaramogi Odinga Teaching and Referral Hospital
        • physical_addressKisumu Kakamega Road
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id247
        • application_id286
        • county_id42
        • site_nameKisumu East District Hospital
        • physical_addressKisumu
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id158
        • application_id286
        • sponsorNational Institute of Health
        • sponsor_type(null)
        • contact_personLynne M. Mofenson MD Chief, Maternal and Pediatric Infectious Disease Branch
        • addressNational Institutes of Health 6100 Executive Boulevard, Room 4B11 Rockville, MD 20852
        • telephone_numberTelephone: 301-435-6870
        • fax_number
        • cell_numberN/A
        • email_addressLM65D@nih.gov
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
  • 3(array)
    • Application(array)
      • id393
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<p>\n Dafra Pharma and CCR-KEMRI have initiated the first in man clinical Phase 1 study<br />\n using single oral doses of 50 mg, 100 mg and 150 mg of oleylphosphocholine in healthy<br />\n adult males (protocol DRD140-L2.2012, SSC #2512). The study made use of a capsule<br />\n formulation of oleylphophocholine containing 50 mg of active ingredient. The subjects of<br />\n the first three cohorts were receiving one, two or three of those capsules as a single dose.<br />\n Based on the positive results obtained so far, two additional cohorts of 10 volunteers are<br />\n now planned to be dosed with single dose of 200 mg and 250 mg, upon approval by<br />\n KEMRI IRB. The capsule formulation of oleylphosphocholine was of limited shelf life and was only<br />\n meant to be used for early clinical studies. Since the initiation of the Phase 1 trial, the<br />\n pharmaceutical research around the formulation of oleylphosphocholine has progressed<br />\n and the final formulation of the active ingredient intended to be marketed has become<br />\n available. This formulation is in the form of 50 mg oral solid tablets. Our intention is to<br />\n continue the Phase 1 protocol DRD140-L2.2012, SSC #2512 with this new formulation,<br />\n but before, we wish to confirm that both the capsule and tablet formulations of the active<br />\n ingredient are comparable in terms of safety/tolerance, and pharmacokinetics.The primary objective is to evaluate safety and tolerability of single dose 100 mg<br />\n oleylphosphocholine oral solid tablets in healthy male volunteers.The secondary objective is to obtain data on pharmacokinetics following oral<br />\n administration of single dose 100 mg tablets oleylphosphocholine in human, and to<br />\n calculate bioequivalence with the capsule formulation</p>\n<p>\n  </p>\n
      • study_title<p>\n Plasma concentration profiles after oral<br />\n administration of oleylphosphocholine tablet<br />\n formulation: safety, tolerability and pharmacokinetics<br />\n of 100 mg single dose in healthy male volunteers.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/04/02
      • version_no2.1
      • date_of_protocol03-02-2015
      • study_drugOleylphosphocholine (OlPC)
      • disease_conditionleishmaniasis
      • 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_nameOleylphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Rashid J R
      • declaration_date129-04-2015
      • declaration_principal_investigatorDr Njenga S Njoroge CO_PI
      • declaration_date229-04-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Healthy males, adults, aged 18-45 years inclusively at the time of screening.<br />\n · Weight between 45 kg and 80 kg inclusively.<br />\n · Written informed consent obtained from the participant before study start.</p>\n
      • principal_exclusion_criteria<p>\n HIV positive or other immunosuppressive statusSymptomatic infection<br />\n · Concomitant exposure to other investigational medicinal products<br />\n · History of alcohol or drug abuse<br />\n · Known hypersensitivity to miltefosine<br />\n · Known skin condition which could confound assessments of rash as an adverse event.<br />\n · Lipid disorders, including abnormal blood levels of total cholesterol, HDL, LDL, and<br />\n triglycerides.<br />\n · Laboratory result abnormalities, including clinically significant abnormal ECG, liver function<br />\n tests more than x3 upper limit of normal, creatinine outside normal range.<br />\n · Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. Or any<br />\n other findings that in the opinion of the PI may increase the risk to the participant from<br />\n participating in the study.<br />\n · Other condition that in the opinion of the investigator would jeopardize the safety or rights of<br />\n a participant in the trial or would render the participant unable to comply with the protocol.</p>\n
      • primary_end_points<p>\n Documentation of solicited and spontaneously reported adverse events after administration<br />\n during a 29-day follow-up period, i.e. from day 0 (day of administration) to day 28 postadministration.<br />\n · Documentation of the occurrence of serious adverse events (SAE) throughout the study<br />\n period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to<br />\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are<br />\n dedicated to Phase 1 clinical trials.<br />\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre<br />\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The<br />\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for<br />\n maintenance and for running the different tests.<br />\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory<br />\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17<br />\n research nurses. A pharmacy and a qualified pharmacist are also present on site.<br />\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP<br />\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.<br />\n The team of CCR has conducted several clinical trials including Phase 1 studies.</p>\n
      • other_details_explanation<p>\n Dafra Pharma distributes its products exclusively on the African market and has always<br />\n focused on making drugs available for the African population, where the need is high and<br />\n drugs need to be affordable. Therefore it is ethically fair that the African population and<br />\n scientific community, who are likely to use the medicine in clinical practice, participate in<br />\n the clinical development. This will allow reliable and accurate data about tolerance and<br />\n pharmacokinetics to be compiled in the target population.<br />\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a<br />\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic<br />\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to<br />\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic<br />\n profile of OlPC in healthy Kenyan volunteers.<br />\n  </p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n NONE</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_durationEnrolment and clinical part: up to 3 months Data analysis and preliminary report: 2 months Final report: 1 month
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI
      • single_site_physical_addressoff mbagathi way
      • single_site_contact_personDr J R Rashid
      • single_site_telephone254 20 2726781
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site10
      • total_participants_worldwide10
      • 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_female0
      • 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_nameRashid Juma
      • investigator1_middle_name
      • investigator1_family_nameRavasco
      • investigator1_qualificationMedical Doctor MBChB, MMed(medicine)
      • investigator1_professional_addressCenter for Clinical Research Kenya Medical Research Institute (KEMRI) Box 20778-00202 Nairobi, Kenya
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants10
      • notification
      • approval_date15-06-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2015
      • 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)
      • modified2015-06-15 19:23:44
      • created2015-04-29 08:57:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id266
        • application_id393
        • given_nameRavasco
        • middle_nameRashid
        • family_nameJuma
        • qualificationMBChB Mmed(Internal Medicine)
        • professional_address KEMRI 54840-00200 Nairobi
        • telephone0723726526
        • emailjrashid@kemri.org
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
    • SiteDetail(array)
      • 0(array)
        • id322
        • application_id393
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id205
        • application_id393
        • sponsorDafra Pharma International NV
        • sponsor_type(null)
        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 61 78 20
        • fax_number+32 14 47 29 90
        • cell_number+32 475 912 920
        • email_addressbruno.jansen@dafra.be
        • created2015-04-29 09:24:50
        • modified2015-04-29 18:14:29
  • 4(array)
    • Application(array)
      • id1067
      • user_id667
      • trial_status_id8
      • abstract_of_study<p>\n Adolescent girls and young women (AGYW) in Kenya face parallel epidemics for unintended pregnancy and HIV. Existing reproductive health and family planning programs are acceptable and effective entry points to reach AGYW with comprehensive services to prevent these events. AGYW seeking care for an early pregnancy loss- whether from a spontaneous miscarriage or induced abortion- face these epidemics and integrating HIV prevention services, particularly daily oral PrEP, into PAC services is an opportune method to reach them. PrEP is widely available in Kenya for people with substantial risk for HIV. Prior formative work by the protocol investigators found that young women accessing PAC had characteristics (existing STI infection and sexual behavior) that render them susceptible to HIV acquisition. More than half of the women indicated willingness to use PrEP. An additional important finding from the study was that PrEP screening and initiation could be integrated into services provided through the PAC clinic and follow-up for PrEP refills conducted outside of these clinics (e.g. family planning-FP- clinics).</p>\n<p>\n Through the proposed work, we plan to pilot PrEP integration into PAC services among 14 health facilities (public and private) providing PAC to AGYW in Thika, Nairobi, and Kisumu. The project will enroll 2000 AGYW accessing PAC services and engage a subset of 400 for research procedures to evaluate: 1) uptake, adherence, and continuation of PrEP and FP 2) linkage and follow-up on PrEP and FP services 3) impact of enhanced adherence support on PrEP continuation and adherence 4) experiences of young women and providers with an integrated PrEP program, and 5) factors associated with adherence to PrEP and FP. Specifically, we hope that the work will result in robust recommendations for how to optimize and advance long-standing delivery of HIV prevention as part of PAC services in Kenya and similar settings.</p>\n
      • study_title<p>\n PILOTING HIV PRE-EXPOSURE PROPHYLAXIS (PREP) INTEGRATION INTO SERVICES FOR EARLY PREGNANCY LOSS</p>\n
      • laymans_summary<p style=\"margin:0cm;margin-bottom:.0001pt;text-align:justify\">\n <span style=\"font-size:11.0pt;font-family:"Arial",sans-serif;color:#0E101A\">Adolescent girls and young women (AGYW) receiving care following a pregnancy loss – whether from a spontaneous miscarriage or induced abortion - are extremely vulnerable to ongoing sexual and HIV risk because of infrequent condom use, recent sexual debut, and experiences with psychosocial distress, stigma, and violence that often characterize their recent past. . Results from prior formative work showed that AGYW accessing services from PAC clinics were at a high risk for HIV infection and willing to initiate PrEP alongside PAC services but would only access refills from outside of these clinics (e.g. at family planning clinics). Accessing these women through post-abortal care (PAC) clinics provides an entry point to engage women in HIV prevention, specifically oral PrEP, because of the HIV risk they face. Through the proposed study, we will assess the feasibility and impact of using PAC services in both private and public facilities as an entry point to link AGYW to PrEP, as well as integrated PrEP and contraceptive services in Thika, Nairobi, and Kisumu. This project will result in recommendations for how to optimize and advance the delivery of HIV prevention services as part of PAC care in Kenya and similar settings.</span></p>\n
      • short_titleThe PrEDIRA Study
      • protocol_noECCT/21/09/06
      • version_no1.0
      • date_of_protocol15-07-2021
      • study_drugEmtricitabine and Tenofovir Disoproxil Fumarate Tablets
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEmtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-ucsf.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_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • 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_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement0
      • declaration_applicantDr. Greshon Rota
      • declaration_date122-09-2021
      • declaration_principal_investigatorProf Elizabeth Bukusi
      • declaration_date222-09-2021
      • placebo_presentNo
      • study_objectives<ol>\n <li>\n <strong>Among women accessing post-abortal care (PAC) services in Kenya, we will use methods from implementation science to evaluate feasibility of integrating PrEP into PAC services by estimating: </strong><strong>a) uptake of PrEP and FP at the PAC site</strong>\n <p style=\"margin-left: 36pt;\">\n <strong>b) linkage of women from PAC to follow-on PrEP and FP services</strong></p>\n <p style=\"margin-left: 36pt;\">\n <strong>c) retention in PrEP and FP programs</strong></p>\n <p style=\"margin-left: 36pt;\">\n <strong>d) continuation of PrEP and FP during a 6 month period</strong></p>\n </li>\n <li>\n <strong>To determine the effect of enhanced adherence activities on PrEP continuation and adherence</strong></li>\n <li>\n <strong>To qualitatively evaluate the feasibility of integrating PrEP into PAC services and experiences of young women and providers with an integrated PrEP program</strong></li>\n <li>\n <strong>To determine factors associated with adherence to PrEP and FP</strong></li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Aged 15-30 years</li>\n <li>\n HIV-negative, according to national HIV testing algorithm</li>\n <li>\n Accessing services for early pregnancy loss at one of the participating facilities and other facilities within the program area</li>\n <li>\n Not currently using PrEP</li>\n <li>\n Eligible for PrEP, according to Kenya national guidelines </li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Living with HIV, according to national HIV testing algorithm</li>\n <li>\n Has any condition (social or medical) which in the opinion of the investigator would make program participation unsafe</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n  Analytic approach: Through data abstracted from facility records, we will describe the number of women accessing PAC services/month, the proportion of these women who have substantial HIV risk, and the proportion of these women who initiate PrEP/FP. Through data abstraction at partner programs providing long term PrEP and FP services, we identify women being referred through the PAC PrEP program and estimate the proportion of women referred who actually link to these services, are retained each month in the program, and continue to receive PrEP medication. We will use these data to populate a “PrEP cascade” showing the continuum of women’s engagement with PrEP and family planning</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • 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_specifyImplementation Science
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n Study PI: Prof. Elizabet Bukusi, Dr. Nelly Mugo, Renee Heffron PHD</div>\n<div>\n Co-Investigator: Dr. Victor Omollo</div>\n<div>\n Co-Investigator: Josephine Odoyo</div>\n<div>\n Study Cordinator: Dr. Felix Mogaka</div>\n<div>\n Study Cordinator: Kevin Kamolloh</div>\n<div>\n Study Pharmacist: Dr. Greshon Rota</div>\n<div>\n Data: 2</div>\n<div>\n Research Assistants-3</div>\n<div>\n Administrator -1</div>\n<div>\n Study nurse-1</div>\n
      • other_details_explanation<p>\n This study will be conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration24 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites14
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site400
      • total_participants_worldwide400
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • 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_nameProf. Elizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
      • investigator1_professional_addressBox 19464, post code 00202, Nairobi
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants400
      • notification
      • approval_date10-11-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-10-16 13:53:34
      • created2021-09-14 07:01:58
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id728
        • application_id1067
        • given_nameProf. Elizabeth
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics)
        • professional_addressBox 19464, post code 00202, Nairobi
        • telephone+254 733617503
        • emailebukusi@rctp.or.ke
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
      • 1(array)
        • id729
        • application_id1067
        • given_nameDr. Nelly
        • middle_name
        • family_nameMugo
        • qualificationMBChB, Mmed, MPH
        • professional_addressPartners in Health, Research and Development - Thika
        • telephone067 2222561
        • emailrwamba@uw.edu
        • created2021-09-14 07:14:32
        • modified2021-09-22 12:43:56
      • 2(array)
        • id730
        • application_id1067
        • given_nameRenee
        • middle_name
        • family_nameHeffron
        • qualificationMPH, PhD
        • professional_address4333 Brooklyn Ave.NE, Box 359470 Seatle, WA 98195-9470
        • telephone+1206-520-3800
        • emailrheffron@uw.edu
        • created2021-09-14 07:14:32
        • modified2021-09-22 12:43:56
    • SiteDetail(array)
      • 0(array)
        • id1133
        • application_id1067
        • county_id42
        • site_nameKEMRI RCTP
        • physical_addressLUMUMBA SUBCOUNTY HOSPITAL - KISUMU
        • contact_details+254 720 018880, P.O BOX 614-40100
        • contact_personJOSEPHINE ODOYO
        • site_capacity(null)
        • misc(null)
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1134
        • application_id1067
        • county_id22
        • site_namePARTNERS IN HEALTH RESEARCH AND DEVELOPMENT - THIKA
        • physical_addressTHIKA TOWN
        • contact_detailsP.O BOX 112
        • contact_personPETER MOGERE
        • site_capacity(null)
        • misc(null)
        • created2021-09-14 07:37:56
        • modified2021-09-22 12:43:56
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id541
        • application_id1067
        • sponsorChildren’s Investment Fund Foundation
        • sponsor_typeOthers
        • contact_person
        • address7 Clifford Street London, W1S 2FT United Kingdom
        • telephone_number+44 (0) 20 3740 6100
        • fax_number
        • cell_number+44 (0) 20 3740 6100
        • email_addressinfo@ciff.org
        • created2021-09-14 07:07:35
        • modified2021-09-22 12:43:56
• 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