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• applications(array)
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    • Application(array)
      • id68
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Antiretroviral-based HIV-1 prevention strategies– including 1) antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and 2) pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition– are among the most promising new approaches for dramatically decreasing HIV-1 spread. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected). Stable, heterosexual African HIV-1 serodiscordant couples face high risk of HIV-1 transmission, from within the partnership and from outside partners, and are a priority population for prevention interventions. Importantly, during the past year, both ART (HPTN 052) and PrEP (Partners PrEP Study) have demonstrated high efficacy for HIV-1 protection when used by members of HIV-1 serodiscordant couples. Critical unanswered questions for successful implementation of antiretroviral-based HIV-1 prevention include how to target these strategies to the highest-risk couples and whether HIV-1 infected persons with asymptomatic disease would accept ART to reduce their risk for transmitting HIV-1, at-risk HIV-1 negative persons would use PrEP, and both would sustain high adherence needed for high effectiveness. This protocol describes an open-label prospective study among high-risk African HIV-1 serodiscordant couples to determine user preferences for ART and PrEP and to optimize targeted delivery and sustained use of these interventions.</p>\n
      • study_title<p>\n An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples The Partners PrEP Study Demonstration Project</p>\n
      • laymans_summary<p>\n Multiple stakeholder discussions have noted that demonstration of deliverability and understanding adherence and sexual behavior in the context of ART for prevention and PrEP use outside of clinical trials are critical factors to consider in anticipating roll-out of these strategies. HIV-1 serodiscordant couples are a primary target for implementation of ART for prevention and PrEP, particularly for East Africa. Critical unanswered questions for successful implementation of antiretroviral-based HIV- 1 prevention include how to target these expensive prevention strategies to realize maximum population HIV -1 prevention benefits and whether HIV-1 infected persons with asymptomatic disease would accept ART to reduce their risk for transmitting HIV-1, at-risk HIV-1 negative persons would use PrEP, and both would sustain high adherence needed for high effectiveness. Couples may potentially have the opportunity to use ART or PrEP for prevention; however, costs would prohibit simultaneous use in most settings. Thus, staged use – i.e., PrEP until the HIV-1 infected partner initiates ART and achieves viral suppression – may be an effective and cost- effective approach [44], and it is the approach we propose. Successful implementation of ART and PrEP for prevention in HIV-1 serodiscordant couples will need to 1) target delivery to highest-risk couples, 2) respond to couples’ preferences for and barriers to use of PrEP and ART, 3) achieve high uptake and sustained adherence and 4) consider how to discontinue PrEP if the HIV-1 infected partner initiates ART. This study proposes to address these key questions.</p>\n
      • short_titleAn open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples
      • protocol_noECCT/13/03/02
      • version_no2.0
      • date_of_protocol10-07-2012
      • study_drugTENOFOVIR/EMTRICITABINE(TRUVADA)
      • disease_conditionHEALTHY PARTICIPANTS
      • 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_nameTENEFOVIR/EMTRICITABINE
      • 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_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample0
      • 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_date128-03-2013
      • declaration_principal_investigatorDR.EIZABETH ANNE BUKUSI ( LOCAL PRINCIPAL INVESTIGATOR)
      • declaration_date228-03-2013
      • placebo_presentNo
      • study_objectives<p>\n 1. We will evaluate the ability to do targeted enrollment of higher-risk HIV-1 serodiscordant couples into a longitudinal HIV-1 prevention study</p>\n<p>\n 2.</p>\n<p>\n We will assess user preferences among high-risk HIV-1 serodiscordant couples for ART initiation for HIV-1 infected partners and PrEP for HIV- 1 uninfected partners.</p>\n<p>\n 3: We will ascertain initiation of and adherence to PrEP among HIV-1 uninfected partners, when implemented as a bridge to ART.</p>\n<p>\n 4. We will ascertain initiation of and adherence to ART among HIV-1 infected partners</p>\n<p>\n 5. We will assess factors influencing preferences, uptake and adherence for antiretroviral-based HIV-1 prevention</p>\n<p>\n 6. We will assess the feasibility of PrEP discontinuation in couples in which the HIV-1 infected partner initiates ART</p>\n<p>\n 7. We will assess PrEP use and birth outcomes among HIV-1 uninfected women who choose to continue PrEP during pregnancy</p>\n
      • principal_inclusion_criteria<p>\n -HIV DISCORDANT COUPLES AND WILLING TO ENTER STUDY AS COUPLES</p>\n<p>\n -ABOVE 18 YEARS OF AGE</p>\n<p>\n - ABLE AND WILLING TO PROVIDE WRITTEN INFORMED CONSENT</p>\n<p>\n -ADEQUATE RENAL FUNCTION</p>\n<p>\n -HIV POSITIVE PARTNER NOT ON ART</p>\n<p>\n -NOT ENROLLED ON HIV TREATMENT STUDY</p>\n<p>\n -NOT ON PRE EXPOSURE PROPHYLAXIS</p>\n
      • principal_exclusion_criteria<p>\n -HIV POSITIVE PARTNER ALREADY ON ART</p>\n<p>\n -INADEQUATE RENAL FUNCTION</p>\n<p>\n -ENROLLED IN HIV TREATMENT STUDY</p>\n<p>\n -NOT WILLING TO PROVIDE WRITTEN CONSENT</p>\n<p>\n -BELOW 18 YEARS OF AGE</p>\n<p>\n -HIV NEGATIVE FEMALES NOT PREGNANT OR BREASTFEEDING AT ENROLLMENT</p>\n
      • primary_end_points<p>\n -ENROLLMENT OF HIGH RISK HIV-1 SERODISCORDANT COUPLES INTO A LONGITUDINAL HIV STUDY</p>\n<p>\n -HIV SERO DISCORDANT COUPLES  CHOICE ON EITHER ART OR PREP</p>\n<p>\n -ADHERENCE TO PREP AMONG HIV-1 UN-INFECTECTED PARTNERS WHEN THEY USE PREP AS A BRIDGE TO ART</p>\n<p>\n -KNOWING THE FACTORS THAT INFLUENCE PREFERENCE,UPTAKE AND ADHERENCE FOR ANTIRETROVIRALS BASED HIV 1 PREVENTION </p>\n<p>\n -WHEN WE ASCERTAIN INITIATION OF AND ADHERENCE TO ART AMONG HIV INFECTED PARTNERS</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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n DR.ELIZABETH BUKUSI-PRINCIPAL INVESTIGATOR</p>\n<p>\n JOSEPHINE ODOYO-CO INVESTIGATOR</p>\n<p>\n RAPHAEL ONDONDO-CO INVETSIGATOR</p>\n<p>\n IMELDA WAKHUNGU-CO INVESTIGATOR</p>\n<p>\n JOEL ODONDI-CO INVESTIGATOR</p>\n<p>\n DR ANGELINE ACHOKA-LEAD PHARMACIST</p>\n<p>\n ERIC SEDAH- PHARMACEUTICAL TECHNOLOGIST</p>\n<p>\n JACKSON ACHANDO - QA/QC COORDINATOR</p>\n<p>\n  ALFRED OBIERO- ADMINSTRATOR</p>\n<p>\n LYNNAH MEMO-CLEANER MESSENGER</p>\n<p>\n LOICE OKUMU-RECEPTIONIST</p>\n<p>\n BENARD RONO - ASSISTANT DATA MANAGER</p>\n<p>\n VIOLET KWACH-DATA CLERK</p>\n<p>\n JULIUS ODACHA-DRIVER</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n KEMRI/NATIONAL ETHICS REVIEW COMMITTEE DATED 11TH  MARCH 2013</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_countriesYes
      • multiple_member_states2
      • number_of_sites2
      • multi_country_listUGANDA AND KENYA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKISUMU-300\nTHIKA-500
      • total_participants_worldwideN/A
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_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_nameDR.ELIZABETH ANNE BUKUSI
      • investigator1_middle_name
      • investigator1_family_nameELIZABETH ANNE BUKUSI
      • investigator1_qualificationMBCHB,M.MED(OBSGYN),MPH.PHD
      • investigator1_professional_addressP.O BOX 54840 00200 NAIROBI
      • investigator1_telephone0733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants300-500 COUPLES
      • notification
      • approval_date10-07-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report: An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples The Partners PrEP Study Demonstration Project.\nThe objectives of the study were to evaluate the ability to do targeted enrollment of higher-risk HIV-1 serodiscordant couples into a longitudinal HIV-1 prevention study. \nTo assess user preferences among high-risk HIV-1 serodiscordant couples for ART initiation for HIV-1 infected partners and PrEP for HIV-1 uninfected partners. \nTo ascertain initiation of and adherence to PrEP among HIV-1 uninfected partners, when implemented as a bridge to ART. \nTo ascertain initiation of and adherence to ART among HIV-1 infected partners. \nTo assess factors influencing preferences, uptake and adherence for antiretroviral-based HIV-1 prevention. \nTo assess the feasibility of PrEP discontinuation in couples in which the HIV-1 infected partner initiates ART. \nTo assess PrEP use and birth outcomes among HIV-1 uninfected women who choose to continue PrEP during pregnancy.\nA total of 1013 heterosexual HIV serodiscordant couples were enrolled with 78% of partnerships initiated on Art, and 97% used PrEP during a median follow up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (>_85%). \nHIV-1 transmission rates were considerably lower than would have been anticipated the strategy of providing time-limited PrEP and ART to HIV serodiscordant couples reduced HIV transmission by 96%.\nNearly all of the HIV negative partners used PrEP for at least 6 months while their HIV positive partners were getting used to using ART quickly after provider recommendation.\nIntegrating PrEP and ART works because PrEP provides immediate protection against HIV infection for the negative partner. Once ART has been used for at least 6 months and created a state of viral suppression, the PrEP can be stopped while ART continues as a powerful prevention and treatment strategy for couples\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-05-27 15:20:39
      • created2013-03-22 10:33:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id45
        • application_id68
        • given_nameDR.ELIZABETH ANNE BUKUSI
        • middle_name
        • family_nameELIZABETH ANNE BUKUSI
        • qualificationMBCHB,M.MED(OBSGYN),MPH.PHD
        • professional_addressP.O BOX 54840 00200 NAIROBI
        • telephone0733617503
        • emailebukusi@rctp.or.ke
        • created2013-03-22 10:53:03
        • modified2020-05-27 15:20:39
    • SiteDetail(array)
      • 0(array)
        • id59
        • application_id68
        • county_id47
        • site_nameTHIKA
        • physical_addressUNITED BUILDING 3RD FLOOR KENYATTA NATIONAL HOSPITAL
        • contact_detailsP.O BOX 19865 NAIROBI
        • contact_personDR.NELLY MUGO
        • site_capacity(null)
        • misc(null)
        • created2013-03-22 10:53:03
        • modified2020-05-27 15:20:40
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id34
        • application_id68
        • sponsorUNIVERSITY OF WASHINGTON
        • sponsor_typeOthers
        • contact_personDr. Jared Beaten
        • address2065203831
        • telephone_number2065203808
        • fax_number
        • cell_number2066018598
        • email_addressjbeaten@u.washington.edu
        • created2013-03-22 10:53:03
        • modified2020-05-27 15:20:39
  • 1(array)
    • Application(array)
      • id49
      • user_id45
      • trial_status_id5
      • abstract_of_study<p>\n  </p>\n<p align=\"left\">\n <u>Background</u>: The purpose of this protocol is to evaluate the acceptability of a progesterone vaginal ring (PVR) as a contraceptive among women in sub-Saharan Africa.  Clinical trials have proven the PVR to be an effective contraceptive; furthermore, it is currently registered in 8 countries in Latin America.  Although proven safe and effective in clinical trials, there is a need to assess acceptability prior to introduction into country programs.  To this end, the Council is planning to conduct PVR acceptability studies in Kenya, Nigeria and Senegal, for which we are seeking Institutional Review Board (IRB) approval. </p>\n<p>\n The acceptability study is one component of a number of activities as part of pre-introductory efforts.  Other activities include global and national consultations, assessments and documentation of the regulatory and procurement frameworks, and market segmentation and demand analysis.  As part of the acceptability assessment described in this protocol, information will be gathered from various stakeholders to evaluate factors influencing acceptability; respondents will be PVR users, health care providers, and community members. Both quantitative and qualitative data will be gathered from the participants through a variety of instruments.</p>\n<p>\n <u>Study participants and data collection</u>: Women aged 18-35 who are (1) 6-9 weeks postpartum, (2) still amenorrheic,(3) breastfeeding fully/nearly fully and wish to breastfeed a minimum of four times per day through two ring cycles (6 months), and (4) willing to participate in the study will provide informed consent before any other study procedures commence. Consenting women who meet the criteria for admission will be screened by a medical provider andthose who are eligible will be enrolled in the study. Participants will be provided with2 rings (on separate visits) and counseled on use and compliance with study protocol, after which they will initiate use of the method.  Participating women will return twice for follow-up visits (at months 3 and 6), at which time they will be interviewed about perceptions and experiences with using the PVR and have relevant medical checkups.  Additionally, 5 participants in each country, who have given informed consent, will give in-depth interviews (IDIs) about their user experience with the PVR to a trained data collector at months 1, 3, and 6. Upon completion of the study, women will be offered another contraceptive method if desired. Participation is voluntary and women are free to leave the study at any point if they chose to do so.</p>\n<p>\n Health care providers (HCPs) from the 18 identified sites in Kenya, Nigeria and Senegal will be trained on insertion and removal of the PVR as well as principles of the International Conference on Harmonization Good Clinical Practice (ICH GCP) standards, referred to as “GCP” in this document, for conducting the study. Consenting HCPs will be asked to complete a pre- and post-training questionnaire, as well as one at the conclusion of the study, to evaluate and track changes in knowledge and attitudes regarding the PVR.</p>\n<p>\n A minimum of 1 focus group discussion (FGD) will be convened in each country to evaluate key community members’ perceptions about the PVR.  Participants, not necessarily in the same group discussion, will consist of women aged 18-49, community elders, religious leaders, breastfeeding support group members (if they exist), health committee members, and family members such as mothers, mothers-in-laws, and husbands. Participantswill sign an informed consent before taking part in the FGD. Qualitative data gleaned from key community members will provide valuable insight into factors influencing the acceptability of the PVR in a particular community. </p>\n<p align=\"left\">\n <u>Ethical issues</u>: Informed consent will be taken from all study participants—users, providers, and community members. Potential participants will be counseled about the study and only those who can give informed consent will be enrolled. The informed consent form, approved by the Population Council’s IRB and the local IRB, must be obtained from each participant prior to performing any procedures outlined in the protocol. </p>\n<p align=\"left\">\n Risks to users, providers, and community: There are minimal risks involved with the use of the PVR during this acceptability study.  The PVR is a product that has been clinically studied and found to be safe and effective; it is also approved for use in several Latin American countries.  The most significant risk is an unintended pregnancy arising from improper screening by providers or non-adherence to use instructions by the user.  We aim to mitigate screening risks by enrolling women (1) who are 6-9 weeks postpartum and hence less likely to be ovulating (2) are still amenorrheic and (3) who have a negative pregnancy test result.  We aim to mitigate risks due to non-adherence by counseling all users about the conditions under which the PVR is effective and the options they would have should pregnancy occur. They will be informed that they will be treated free of charge and managed according to hospital practice with their consent.  PVR users who become pregnant will be advised to discontinue use and will be referred for antenatal care services at the facility or any other facility of their choice. Other risks to the user are associated with vaginal discharge or discomfort. These will be managed and treated free of cost to the user. All user information is for study purposes only and will remain confidential.</p>\n<p align=\"left\">\n There are no risks posed to providers or community members participating in the FDGs. They are free to discontinue participation at any time without fear of consequences, and all information shared by them will be confidential.</p>\n<p align=\"left\">\n Remuneration:  Remuneration will be nominal and will use standard guidelines used in the country.    Compensation study participants will receive includes reimbursement for travel to and from the study sites for follow up visits, interviews, or FGDs.  This will be KSh. 300 per participant per visit in Kenya. FGD participants will also receive refreshments.</p>\n
      • study_title<p>\n Assessing the acceptability of a progesterone vaginal ring (PVR) as a new contraceptive option in sub-Saharan Africa</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/03/01
      • version_no1.1
      • date_of_protocol25-02-2013
      • study_drugNot applicable
      • disease_conditionNot applicable
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameProgesterone Vaginal Ring (PVR)
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfonyango@popcouncil.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_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_applicantDr. Francis Obare
      • declaration_date128-02-2013
      • declaration_principal_investigatorAssociate
      • declaration_date228-02-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<p style=\"margin-left: 31.5pt\">\n 1.       Able to provide informed consent</p>\n<p style=\"margin-left: 31.5pt\">\n 2.       Age 18 to 35 years (inclusive)</p>\n<p style=\"margin-left: 31.5pt\">\n 3.       Delivered a healthy singleton infant 6 to 9 weeks prior to study enrollment</p>\n<p style=\"margin-left: 31.5pt\">\n 4.       Has at least (1) living child and is fully/nearly fully breastfeeding the new infant</p>\n<p style=\"margin-left: 31.5pt\">\n 5.       Willing to continue breastfeeding infant a minimum of 4 times per day for at least 6 months.</p>\n<p style=\"margin-left: 31.5pt\">\n 6.       Is in good health as confirmed by medical history, physical examination (including vital signs and diagnosis/treatment of vaginal infection per the standard of care in each country. Treatment of vaginal infection is required prior to enrollment.)</p>\n<p style=\"margin-left: 31.5pt\">\n 7.       Has or expects to have regular exposure to the risk of pregnancy</p>\n<p style=\"margin-left: 31.5pt\">\n 8.       Willing to choose the PVR as contraceptive method</p>\n<p style=\"margin-left: 31.5pt\">\n 9.       Willing and able to follow study procedures</p>\n<p style=\"margin-left: 31.5pt\">\n 10.   Expects to continue living in an area accessible to the study site for the duration of the study.</p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p style=\"margin-left: 31.5pt\">\n  </p>\n<p style=\"margin-left: 31.5pt\">\n 1.       Is pregnant or suspected of being pregnant</p>\n<p style=\"margin-left: 31.5pt\">\n 2.       Breastfeeding less than fully/nearly fully</p>\n<p style=\"margin-left: 31.5pt\">\n 3.       Hypersensitivity to hormonal preparations or silicone rubber</p>\n<p style=\"margin-left: 31.5pt\">\n 4.       HIV positive or in a discordant relationship</p>\n<p style=\"margin-left: 31.5pt\">\n 5.       Presence of genital or urinary tract infection</p>\n<p style=\"margin-left: 31.5pt\">\n 6.       Dyspareunia</p>\n<p style=\"margin-left: 31.5pt\">\n 7.       History of Human Papillomavirus (HPV)</p>\n<p style=\"margin-left: 31.5pt\">\n 8.       History of bacterial infections such as Chlamydia and gonorrhea</p>\n<p style=\"margin-left: 31.5pt\">\n 9.       History of pelvic inflammatory disease (PID) or salpingitis since delivery</p>\n<p style=\"margin-left: 31.5pt\">\n 10.   History of chronic constipation</p>\n<p style=\"margin-left: 31.5pt\">\n 11.   Clinically relevant genital prolapse</p>\n<p style=\"margin-left: 31.5pt\">\n 12.   Has history of generalized urticaria</p>\n<p style=\"margin-left: 31.5pt\">\n 13.   Any chronic condition requiring continuous or regular use of medication or herbals prescribed by healers</p>\n<p style=\"margin-left: 31.5pt\">\n 14.   Has a history of thrombophlebitis or thromboembolism</p>\n<p style=\"margin-left: 31.5pt\">\n 15.   History of and/or current depression</p>\n<p style=\"margin-left: 31.5pt\">\n 16.   History of epilepsy or convulsive disorder</p>\n<p style=\"margin-left: 31.5pt\">\n 17.   Had an ectopic pregnancy</p>\n<p style=\"margin-left: 31.5pt\">\n 18.   Has vaginal bleeding not attributable to menses</p>\n<p style=\"margin-left: 31.5pt\">\n 19.   Known or suspected carcinoma of the breast</p>\n<p style=\"margin-left: 31.5pt\">\n 20.   Has had any other known or suspected neoplasia within last 5 years</p>\n<p style=\"margin-left: 31.5pt\">\n 21.   Not exposed to risk of pregnancy</p>\n<p style=\"margin-left: 31.5pt\">\n 22.   Use of chronic medications, Rifampicin, Griseofluvin, barbiturates, phenytoin, ketoconozole, butazoliden</p>\n<p style=\"margin-left: 31.5pt\">\n 23.   Confirmed hypertension (blood pressure- systolic  more than 140 mm Hg and/or diastolic more than 90mm Hg </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n Pregnancy prevention</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability study
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyAcceptability phase
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The capacity of sites is determined by the ability to offer postnatal care services to postpartum women. All sites have been determined to meet this criterion.</p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n National Council for Science and Technology for Research Permit: Application submitted on February 21, 2013.</p>\n
      • other_details_regulatory_approved<p>\n 1) Kenyatta Nationa Hospital/University of Nairobi Ethics Review Committee (Kenya): Ethical approval granted on February 13, 2013.</p>\n<p>\n 2) Population Council Institutional Review Board (Kenya, Nigeria and Senegal): Ethical approval granted on November 6, 2012.</p>\n<p>\n 3) National Institute for Medical Research (Nigeria): 2 study sites.</p>\n<p>\n 4) Comite Nationale d'Ethique pour la Recherche en Sante (Senegal): 10 sites.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n None.</p>\n
      • estimated_duration6 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(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_statesThree
      • number_of_sites6
      • multi_country_listKenya, Nigeria and Senegal
      • data_monitoring_committeeNo
      • total_enrolment_per_siteThis will depend on number of clients
      • total_participants_worldwide174
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLiambila
      • investigator1_middle_name
      • investigator1_family_nameWilson
      • investigator1_qualificationMSc
      • investigator1_professional_addressP.O. Box 17643-00500, Nairobi
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_No
      • number_participants58
      • notification<p>\n None.</p>\n
      • approval_date13-02-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-03-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Executive Summary</p>\n<p>\n Introduction</p>\n<p>\n The progesterone vaginal ring (PVR) is a ring-shaped device used by postpartum women to extend the contraceptive effectiveness of lactational amenorrhea. The ring is inserted in the vagina 6–9 weeks postpartum (for study purposes; 30–90 days in normal service delivery settings) for continuous use for up to 3 months and replaced with a new one if breastfeeding is continued and extended contraception is desired. The ring diffuses a continuous flow of low-dose progesterone through the vaginal walls, which enters the bloodstream and regulates the woman’s fertility by suppressing ovulation. Previous studies have shown that contraceptive vaginal rings are safe, effective, and well accepted in varied cultural settings. However, the extent to which the ring is acceptable in the sub-Saharan African context is unknown, especially since vaginal rings are a new technology and use of vaginal products such as tampons is limited in the region.</p>\n<p>\n Study objectives</p>\n<p>\n This study examined the acceptability of PVR in Kenya as part of a larger project that was also conducted in Nigeria and Senegal. The specific objectives of the study were to assess the factors influencing the acceptability of the method among clients, their spouses, providers, community members, and those who were counseled on but did not choose the method.</p>\n<p>\n Methods</p>\n<p>\n The study involved prospective follow-up of participants who chose the ring (PVR users) for up to 6 months or two ring cycles, interviews with providers at baseline and endline, as well as cross-sectional interviews with women who were counseled on but did not choose the ring (PVR nonusers) and key stakeholders. A total of 60 PVR users were enrolled for follow-up, another 5 PVR users were enrolled for in-depth interviews, and 58 nonusers were interviewed upon exit. Data collection involved completion of case record forms by providers during enrollment; quantitative exit interviews with clients during enrollment, at 3 months, and at 6 months following ring use or at discontinuation; quantitative exit interviews with PVR nonusers; in-depth interviews with a subset of PVR users at 1 month, 3 months, and 6 months following ring use; in-depth interviews with spouses of PVR users at endline; focus group discussions with community leaders at endline; and self-administered interviews with providers at baseline and endline. Analysis of the quantitative data entailed simple frequencies. Directed content analysis techniques were employed for analyzing the qualitative data.</p>\n<p>\n Key findings</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Acceptability of the ring:</em></strong> The majority of participants who completed the two ring cycles indicated that they would use the ring in the future (92%), their partners or family members would support future use (87%), they would recommend or had already recommended the ring to their friends or family members (92% and 73%, respectively), and that they were willing to pay for the method (77%). In addition, some participants were encouraged by their spouses to use the ring. There were also remarkable positive changes between baseline and follow-up in the perceptions of participants and providers about the ring.</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Reasons for choosing the ring:</em></strong> The most commonly cited reason for choosing the ring among users was that the method is user-controlled (49%). The second major reason was perceived fewer side effects (46%). In addition, some participants chose the ring just to try a new method (14%), while others chose it because their preferred method was not available at the time of the visit (5%). Most users also found the ring easy to insert, remove, and reinsert.</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Client profile:</em></strong> The majority of women who chose the ring were aged 20–29 years (77%), had at least secondary level education (60%), and resided in urban or peri-urban areas (67%). In addition, the majority of PVR users had given birth to at least 2 children (54%) and wanted to space the next birth by at least 4 years (71%).</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Prior use of family planning:</em></strong> Slightly more than one-third of PVR users (37%) were new family planning users. Among women who had previously used a method, the methods ever used were pills (55%), injectables (45%), implants (10%), emergency contraceptive pills (8%), male condoms (5%), intrauterine contraceptive devices—IUDs (5%), and female condoms (3%).</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Subsequent method choice:</em></strong> Those who completed two ring cycles were more likely to switch to implants and intrauterine contraceptive devices (IUDs) compared with those who terminated use (57% versus 17% for implants and 25% versus 6% for IUDs). Switching to long-term methods was also consistent with the finding that most users desired to space the next pregnancy by at least 4 years.</p>\n<p style=\"margin-left:.25in;\">\n §  <strong><em>Discontinuation of use:</em></strong> Participants who discontinued use of the ring did so for various reasons including ring expulsion, experiencing side effects, nonadherence to use instructions, opposition by mother-in-law, husband/partner discomfort during sex, misconception about the method, and experiencing a serious adverse event.   </p>\n<p>\n Implications</p>\n<p style=\"margin-left:.25in;\">\n §  The findings of the study indicate that the ring was acceptable to most clients and key stakeholders. In addition, several positive attributes of the ring that were mentioned by participants are likely to increase uptake of the method.</p>\n<p style=\"margin-left:.25in;\">\n §  The profile of PVR users suggests that young, educated, urban or peri-urban dwellers are likely to be the first acceptors of the method if it is introduced into the country before it diffuses to other segments of the population.</p>\n<p style=\"margin-left:.25in;\">\n §  The reasons given for choosing the ring and the fact that about one-third of the participants were new users suggest that the method is likely to expand contraceptive choice during the postpartum period, enhance women’s autonomy in contraceptive use, and sustain or contribute to an increased contraceptive prevalence rate in the country.</p>\n<p style=\"margin-left:.25in;\">\n §  The finding that those who completed the two ring cycles mostly switched to long-term methods at the end of the study and that most users desired longer birth spacing suggests that programs delivering the ring need to consider mechanisms for bridging users to long-term methods.    </p>\n<p style=\"margin-left:.25in;\">\n §  Given that the ring is a user-controlled method, service-delivery programs should consider ways of ensuring that clients obtain information on correct use, including proper insertion and adherence to use instructions, such as not leaving the ring out for long. Proper insertion and adhering to use instructions are, in turn, likely to reduce instances of ring expulsion and discontinuation.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-02-01 16:31:30
      • created2013-02-25 14:09:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id29
        • application_id49
        • given_nameObare
        • middle_name
        • family_nameFrancis
        • qualificationPhD
        • professional_addressP.O. Box 17643-00500, Nairobi
        • telephone(null)
        • email(null)
        • created2013-02-25 14:12:16
        • modified2013-03-11 06:30:09
    • SiteDetail(array)
      • 0(array)
        • id41
        • application_id49
        • county_id22
        • site_nameNgoliba Health Centre
        • physical_address
        • contact_detailsKiambu
        • contact_personMrs. Priscilla Wambui
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 14:12:16
        • modified2013-03-11 06:30:09
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id42
        • application_id49
        • county_id22
        • site_nameKirwara Sub-district Hospital
        • physical_address
        • contact_detailsKiambu
        • contact_personDr. Maxwell Maina
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 15:20:57
        • modified2013-03-11 06:30:09
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id43
        • application_id49
        • county_id22
        • site_nameIgegania Sub-district Hospital
        • physical_address
        • contact_detailsKiambu
        • contact_personDr. Wycliffe Omollo
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 15:20:57
        • modified2013-03-11 06:30:09
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 3(array)
        • id44
        • application_id49
        • county_id47
        • site_nameMakadara Health Centre
        • physical_address
        • contact_detailsNairobi
        • contact_personMonica Munguti
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 15:20:57
        • modified2013-03-11 06:30:09
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id45
        • application_id49
        • county_id22
        • site_nameThika Level 5
        • physical_address
        • contact_detailsThika
        • contact_personDr. Jonah Mwangi
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 15:20:57
        • modified2013-03-11 06:30:09
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 5(array)
        • id46
        • application_id49
        • county_id22
        • site_nameRuiru Sub-district Hospital
        • physical_address
        • contact_detailsThika
        • contact_personDr. Waturi Kibuti
        • site_capacity(null)
        • misc(null)
        • created2013-02-25 15:20:57
        • modified2013-03-11 06:30:09
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id23
        • application_id49
        • sponsorPopulation Council
        • sponsor_type(null)
        • contact_personDr. Francis Obare
        • addressP.O. Box 17643-00500, Nairobi
        • telephone_number020-2713480
        • fax_number020-2713479
        • cell_number0733-202602
        • email_addressfonyango@popcouncil.org
        • created2013-02-25 14:12:16
        • modified2013-03-11 06:30:09
  • 2(array)
    • Application(array)
      • id208
      • user_id43
      • trial_status_id5
      • abstract_of_study<p>\n AIDS-Related Non-Hodgkin’s Lymphoma (AR-NHL)</p>\n<p>\n Approximately 10% of the world population lives in sub-Saharan Africa, but the region is home to approximately 68% of the world population living with HIV1. Most countries in this region have an HIV prevalence of at least 10% with a number of countries having a prevalence that exceeds 20%2. As the AIDS pandemic advances, the burden of related neoplastic disease is increasing in developing nations3,4. While under-developed cancer registries in sub-Saharan Africa bar a definitive statement being made regarding increases in incidence and prevalence in Africa, it is felt that AIDS-Related Non-Hodgkin’s Lymphoma</p>\n<p>\n (AR-NHL) has rising incidence in this setting. Investigators involved in this study have previously published data that outcomes of AR-NHL are worse than NHL in seronegative patients5. Unfortunately, building on this observation is difficult, as there have been few published data on the tolerance and outcomes of treatment for HIV-associated non-Hodgkin lymphoma (NHL) in sub-Saharan Africa or on the most effective treatment regimen(s) in the varied clinical settings that exist within the region. Although all of the AMC African trial</p>\n<p>\n sites cite CHOP as a “standard of care” for initial treatment of HIV-associated NHL, only one, the Uganda Cancer institute (UCI), has published information on treatment outcomes.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n The most comprehensive accounting of newly diagnosed NHL, from the UCI and recently published by Bateganya et al6, remains limited; between 2004 and 2008 only 51 HIV-infected patients were identified. Although CHOP chemotherapy was administered to approximately two-thirds of all patients, the estimated median survival, even among HIV-seronegative individuals, was less than 1 year and the authors found no evidence that receipt of chemotherapy improved survival. HIV-positive patients receiving antiretroviral therapy had survival rates approximating those of HIV-negative persons, but the adjusted hazard of death was significantly elevated among HIV-positive patients not receiving antiretroviral therapy [adjusted hazard ratio (HR) 8.99, P < 0.001] compared with HIV-negative patients. An updated and as yet unpublished analysis (P. Imani and C. Casper, Personal Communication, January 2012) showed that of the 37 HIV+ patients in this study who received CHOP</p>\n<p>\n chemotherapy, 34 received at least 70% of the standard dose. However, only 4 of 34 patients received at least 6 cycles of chemotherapy. The estimated median survival for all HIV+ patients who received CHOP was approximately 6 months, and only one patient was known</p>\n<p>\n to be alive at 2 years. Interpreting the reason for the poor outcome for both HIV-infected and HIV-uninfected individuals is complicated by a high loss to follow-up rate and lack of information on therapy-related complications and causes of death7, not to mention issues</p>\n<p>\n related to the purity and potency of locally-sourced chemotherapeutic agents.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<p style=\"margin-left:20.0pt;\">\n A Randomized Phase II Trial Of Chop Vs Oral Chemotherapy with Concomitant Antiretroviral Therapy in Patients with HIV-Associated Lymphoma in Sub-Saharan Africa</p>\n
      • laymans_summary<p>\n AMC-068 is a randomized phase II  multi-center clinical trial which compares of intravenous versus oral chemotherapy for HIV-positive individuals with diffuse large B-cell lymphoma. A total of 90 participants are expected to be enrolled with 45 particpants enrolled in each arm.</p>\n<p>\n The purpose of this study is to see if a mixture of anti-cancer medicines given by mouth is as good as a mixture of anti-cancer medicines given by vein for treating Africans with AIDS and NHL. This study will help develop better treatments for people with AIDS and cancer in Africa.</p>\n<p>\n  </p>\n
      • short_titleAMC 068
      • protocol_noECCT/13/02/01
      • version_no3.0
      • date_of_protocol03-08-2012
      • study_drugLomustine, Etoposide, Cyclophosphamide, Procarbazine
      • disease_conditionAIDS ASSOCIATED NON HODGKINS LYMPHOMA
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameLomustine, Etoposide, Cyclophosphamide, Procarbazine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamckenya@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDR. EVANGELINE NJIRU
      • declaration_date127-08-2013
      • declaration_principal_investigatorDR. NAFTALI BUSAKHALA
      • declaration_date227-08-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n <p style=\"margin-left: 5.95pt;\">\n <u>In</u><u>clusion criteria</u></p>\n <ol>\n <li style=\"margin-left: 41.95pt;\">\n  Ability to understand and the willingness to provide informed consent to participate.</li>\n <li style=\"margin-left: 41.95pt;\">\n  Adults, 18 years of age or older. Date of birth and age should be determined based on the best possible information or source documentation available.</li>\n <li style=\"margin-left: 41.95pt;\">\n  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 RNA viral load > 1,000 copies/mL</li>\n <li style=\"margin-left: 41.95pt;\">\n Biopsy-proven, measurable or assessable systemic NHL that has been confirmed by an AMC- approved site pathologist. If a hard copy of the pathology report is unavailable at the time of enrolment, a verbal report by the pathologist confirming the diagnosis must be documented in the medical chart.</li>\n <li style=\"margin-left: 41.95pt;\">\n Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry. Confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry. Please reference the AMC-068 MOP for further instructions on documenting the diagnosis</li>\n <li style=\"margin-left: 41.95pt;\">\n Participants must have fifteen blank (unstained) slides or a diagnostic tissue block must be available for central pathology review by the AMC Core Pathology Laboratory</li>\n <li style=\"margin-left: 41.95pt;\">\n ECOG performance status of 0 - 3 within 7 days of enrolment</li>\n <li style=\"margin-left: 41.95pt;\">\n Participants must have an estimated life expectancy of > 6 weeks.</li>\n <li style=\"margin-left: 41.95pt;\">\n The following acceptable end organ function/laboratory parameters within 7 days prior to enrollment.</li>\n <li style=\"margin-left: 41.95pt;\">\n Hematologic (Participants may enroll with lower hematologic values, if bone marrow involvement is documented. In this case, patients should be transfused to hemoglobin > 8 g/dL):</li>\n </ol>\n <ul>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n WBC ≥ 3,000 cells/L (3.0 x 109 L) or absolute granulocytes ≥ 1500 cells/μL</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n (1.5 x 109 L); and</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Platelets ≥ 100,000 cells/μL (75 x 10 9 L)</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n  Hemoglobin > 8 g/dL (5.0 mmol/)</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Renal – serum creatinine < 3.0 mg/dL (265.2 µmol/L); and</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n Hepatic: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir). If secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 μM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 μM/L).</li>\n <li style=\"margin-left: 7.95pt; text-align: justify;\">\n AST/ALT < 2.5 institutional ULN (unless elevated secondary to lymphomatous involvement of the liver)</li>\n </ul>\n <p>\n  </p>\n <p style=\"margin-left: 25.95pt;\">\n 10. Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 6 weeks prior to enrollment. Participants must be without evidence for CNS lymphoma on neurological exam and have no radiographic evidence (if radiographic studies are done) of CNS lymphoma (inclusive of parenchymal, vitreal, or leptomeningeal involvement).</p>\n <p style=\"margin-left: 25.95pt;\">\n 11. Participants must not have had any prior chemotherapy or radiation therapy and no more than 10 days of corticosteroids in the preceding 30 days prior to enrolment.</p>\n <p style=\"margin-left: 25.95pt;\">\n 12. All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection. Non-suppressed, treatment experienced patients, defined as patients with a viral load ></p>\n <p style=\"margin-left: 25.95pt;\">\n 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative ART regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history. Patients are not allowed to receive zidovudine (AZT) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive. Zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment.</p>\n <p style=\"margin-left: 25.95pt;\">\n 13. Participants of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a pregnancy test within 7 days prior to enrollment and agree to use an effective form of contraception (e.g.,barrier contraception, highly effective hormonal contraception)</p>\n <p style=\"margin-left: 7.95pt;\">\n        14. Participants are allowed to have an active infection(s) for which they are receiving drug treatment provided the clinical status is judged to be stable and   survival is estimated to be at least 6 weeks.</p>\n <p style=\"margin-left: 7.95pt;\">\n        15. Participants must, in the opinion of the investigator, be capable of complying with the protocol.</p>\n <p style=\"margin-left: 7.95pt;\">\n        16. Participants must be able to take oral medications</p>\n <p>\n          17. Participants must have a CD4 count performed within 30 days of enrollment</p>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li style=\"margin-left: 21.05pt;\">\n Inability to provide informed consent.</li>\n <li style=\"margin-left: 21.05pt;\">\n A medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations</li>\n <li style=\"margin-left: 21.05pt;\">\n Participants with circumstances that will not permit completion of the study or required follow-up. For instance, if travel to and from treatment site is an issue</li>\n <li style=\"margin-left: 21.05pt;\">\n Pregnant or breastfeeding</li>\n <li style=\"margin-left: 21.05pt;\">\n nability to swallow oral medications</li>\n</ol>\n
      • primary_end_points<p style=\"margin-left:3.05pt;\">\n To compare the efficacy of standard CHOP and an oral chemotherapy regimen for AR-NHL in Sub-Saharan</p>\n<p>\n Africa with respect to overall survival (OS).</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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>taff</u></p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Naftali Busakhala MBChB, MMed, Principal Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Evangeline W. Njiru- MBChB, MMed- Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Paul Wasike, B Pharm, Pharmacist of Record</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Job Kisuya- Site Coordinator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Grieven Otieno- Data Manager</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Medical Officer-Mildred Hagembe</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Clinical Officer-Enock Sumukwo</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Study Nurse- Peninah Biwott</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Study Nurse- Phyllis Bartilol</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Gilbert Koech, B Pharm- Back-up Pharmacist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Fred Kiplagat, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>ite/Emergency Facilities:</u></p>\n<p>\n  </p>\n<p style=\"margin-left:23.2pt;\">\n ·   AMPATH Program– Has 24 care sites and 34 satellite clinics in North Rift and Western</p>\n<p style=\"margin-left:41.2pt;\">\n Kenya</p>\n<p style=\"margin-left:23.2pt;\">\n ·   AMPATH Oncology Clinic-Has 1 care site and 4 satellite clinics in North Rift and</p>\n<p style=\"margin-left:41.2pt;\">\n Western</p>\n<p style=\"margin-left:23.2pt;\">\n ·   AMPATH Reference Laboratory and MTRH histopathology Laboratory</p>\n<p style=\"margin-left:23.2pt;\">\n ·   Moi Teaching and Referral Hospital (MTRH)- Second largest referral Hospital in Kenya.</p>\n
      • other_details_explanation<p style=\"margin-left:5.2pt;\">\n Eldoret, Kenya is one of the Africa AMC sites. When protocols are developed by the AMC, sites express interests considering the patient population and relevance of the study. Our site expressed interest and was chosen as a participating site.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n AUTHORITY: MOI UNIVERSITY INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE</p>\n<p>\n DATE OF APPROVAL : 22ND NOVEMBER 2012</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration72 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorCurrent Treatment by CHOP
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMOI UNIVERSITY CLINICAL RESEARCH CENTER
      • single_site_physical_addressAMPATH CENTER, NANDI ROAD
      • single_site_contact_personDR. NAFTALI BUSAKHALA
      • single_site_telephone0722496933
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listKENYA: MOI UNIVERSITY CLINICAL RESEARCH CENTER\nUGANDA: UGANDA CANCER INSTITUTE\nZIMBABWE: UNIVERSITY OF ZIMBABWE\nSOUTH AFRICA: WITWATERSRAND UNIVERSITY
      • data_monitoring_committeeYes
      • total_enrolment_per_site90
      • total_participants_worldwide360
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameEVANGELINE
      • investigator1_middle_name
      • investigator1_family_nameNJIRU
      • investigator1_qualificationMBCHB, MMED
      • investigator1_professional_address4606
      • investigator1_telephone0722624353
      • investigator1_emailoyungueva@yahoo.com
      • organisations_transferred_No
      • number_participants90
      • notification
      • approval_date22-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-08-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n AMC-068 was a randomized phase II comparison of intravenous versus oral chemotherapy for HIV-positive diffuse large B-cell lymphoma. Opening in 2016, AMC-068 planned to enroll 90 patients (45 per arm) in Kenya, Malawi, Uganda, and Zimbabwe over 24 months and follow patients for 24 months to assess overall survival. In 2018, the study closed after screening 42 patients but enrolling only 7. Challenges occurred during protocol development, pre-activation, and post activation. During protocol development (2011-2012), major obstacles were limited baseline data to inform study design; lack of consensus among investigators and approving bodies regarding appropriateness of the oral regimen and need for randomized comparison with cyclophosphamide, doxorubicin, vincristine, and prednisone; and heterogeneity across sites in local standards for diagnosis, staging, and treatment. During pre-activation (2012-2016), challenges included unexpected length and layers of regulatory approval across multiple countries, need to upgrade pathology capacity at sites, need to augment existing chemotherapy infusion capacity at sites, and procurement issues for drugs and supplies. Finally, during post activation (2016-2018), challenges included long delays between symptom onset and screening entry for many patients, leading to compromised performance status and organ function; other patient characteristics that frequently led to exclusion, including high tumor proliferative index or other pathologic features that were disallowed; and costs of routine diagnostic procedures often being borne by patients, which also contributed to pre-enrollment delays.</p>\n<p>\n  </p>\n
      • implication_results<p>\n Lessons from AMC-068 are being applied to the design and conduct of new AMC lymphoma trials in SSA, and the study has contributed to a strong operational foundation that will support innovative clinical trials in the future. </p>\n
      • quantity_importedProcarbazine 50mg - 300, Prednisone 50mg - 1500, Lomustine - 160, Etoposide - 180, Cyclosphamide 60mg - 600, Clyclosphamide 500mg - 180, Doxorubicin 2mg/ml - 204 and Vincristine 1mg/ml - 166
      • quantity_dispensedProcarbazine 50mg - 80, Prednisone 50mg - 60, Lomustine - 28, Etoposide - 60, Cyclosphamide 60mg - 100, Clyclosphamide 500mg - 13, Doxorubicin 2mg/ml - 7 and Vincristine 1mg/ml - 12
      • quantity_destroyedProcarbazine 50mg - 220, Prednisone 50mg - 1440, Lomustine - 132, Etoposide - 120, Cyclosphamide 60mg - 500, Clyclosphamide 500mg - 167, Doxorubicin 2mg/ml - 197 and Vincristine 1mg/ml - 154
      • quantity_exportedNot applicable
      • balance_site0
      • final_date0000-00-00
      • modified2024-06-04 14:25:48
      • created2013-08-22 15:41:41
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id139
        • application_id208
        • given_nameNAFTALI
        • middle_nameWISINDI
        • family_nameBUSAKHALA
        • qualificationMBCHB, MMED
        • professional_address4606
        • telephoneO722496933
        • emailnbusakhala@yahoo.com
        • created2013-08-27 16:32:38
        • modified2013-08-27 18:25:49
    • SiteDetail(array)
      • 0(array)
        • id171
        • application_id208
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-08-27 16:32:38
        • modified2013-08-27 18:25:49
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id112
        • application_id208
        • sponsorNational Cancer Institute Office of HIV and AIDS Malignancy (OHAM)
        • sponsor_type(null)
        • contact_person
        • address31 Center Drive, Room 3A33 Bethesda, MD, USA 20852-2440
        • telephone_number301-496-4995
        • fax_number
        • cell_number301-496-4995
        • email_addressNCIOHAMContact@mail.nih.gov
        • created2013-08-27 16:32:38
        • modified2013-08-27 18:25:49
  • 3(array)
    • Application(array)
      • id11
      • user_id27
      • trial_status_id1
      • abstract_of_study<p>\n  </p>\n<p>\n Currently there is wide variation in practice and little evidence to guide the treatment of early cryptococcal infection in HIV-infected individuals with advanced immunosuppression.  However, epidemiologic studies suggest that this may be a promising novel approach to decrease the mortality due to cryptococcal meningitis (CM), the second leading cause of death among HIV-infected individuals in many resource-limited settings. Screening asymptomatic HIV-infected individuals with advanced immunosuppression for serum cryptococcal antigen (CrAg) clearly identifies a population at high risk of CM and death and is a feasible screening method for resource-limited settings.  However, screening with serum CrAg alone without additional diagnostic studies identifies a heterogeneous clinical population with early cryptococcal infection, many of whom already have sub-clinical meningeal infection or fungemia.  The mainstay of anti-cryptococcal therapy in resource-limited settings is oral fluconazole though preliminary evidence suggests this is not an effective treatment.  Thus, there is a critical need for potent therapies that (1) can be safely administered in resource-limited settings and (2) are effective in a heterogeneous population of HIV-infected individuals with advanced immunosuppression and early cryptococcal infection who are initiating anti-retroviral therapy (ART). </p>\n<p>\n This single center, open-label, randomized Phase IIb study is being conducted to assess the safety and estimate the efficacy of oral fluconazole in combination with flucytosine for the treatment of early cryptococcal infection.  The study will be based at two sites supported by Family AIDS Care and Education Services (FACES) in Western Kenya.  A consecutive sample of 100 HIV-infected adults with CD4 cell count ≤100 cells/µl and serum CrAg titer ≥1:2 who have no signs or symptoms of severe, systemic cryptococcal infection will be enrolled. Individuals who meet inclusion and exclusion criteria and consent to participate in the study will be randomized to combination therapy with oral fluconazole (1200mg/day) plus flucytosine (100mg/kg/day) or fluconazole alone for the fourteen days of therapy.  Subsequently both groups will receive anti-retroviral therapy as well as fluconazole 800mg/day for 8 weeks followed by 200mg/day. The primary safety endpoint will be the incidence of treatment-related adverse events and serious adverse events. The primary efficacy endpoint will be survival at 12 weeks.</p>\n<p>\n In addition, we will perform a battery of diagnostic tests including chest radiography, fungal cultures in blood, sputum, urine, stool.  A lumbar puncture will be offered but not required in a separate substudy.  We will perform fungal cultures and cryptococcal antigen testing of the cerebrospinal fluid (CSF), and gram stain, Ziehls-Nielsen stain and India Ink staining of CSF sediment. </p>\n<p>\n Anti-fungal susceptibility testing via broth microdilution and polymerase chain reaction serotyping and mating type analysis will be performed on clinical isolates.  Routine laboratory tests will be performed on-site at FACES and advanced microbiological analysis will be performed by Dr. Christine Bii and her team at the KEMRI Mycology laboratories in Nairobi.  Chest radiography will be performed at the nearest functioning facility—currently we anticipate performing chest radiography at Provincial General Hospital in Kisumu and Sindo District Hospital in Suba.</p>\n<p>\n Finally, participants will be invited to participate in a second substudy in which we will store blood sample and leftover samples from diagnostic tests for future research.</p>\n
      • study_title<p>\n  </p>\n<p>\n An Open Label Randomized Controlled Phase IIb Trial to Determine the Safety of Oral Fluconazole in Combination with Flucytosine as Compared to Fluconazole Alone</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/01/01
      • version_no1.2.1
      • date_of_protocol05-01-2013
      • study_drugFlucytosine
      • disease_conditionEarly cryptococcal 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_nameflucytosine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressanaclaire@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantAna-Claire Meyer
      • declaration_date125-01-2013
      • declaration_principal_investigatorJudith Kwasa (Co-principal investigator and secondary contact)
      • declaration_date225-01-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n Participants must satisfy the following criteria to be enrolled in this study:</p>\n<ol>\n <li>\n Able and willing to give informed consent</li>\n <li>\n Age > 18 years</li>\n <li>\n HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines</li>\n <li>\n CD4+ T-cell count ≤100 cells/µl</li>\n <li>\n Serum CrAg titer≥1:2</li>\n <li>\n Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n Potential participants who meet any of the following criteria will be excluded from participating in the study.</p>\n<ol>\n <li>\n clinical meningitis:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n fever>39.0°C, AND</li>\n <li>\n severe headache, AND</li>\n <li>\n At least one of the following:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n meningismus,</li>\n <li>\n photophobia,</li>\n <li>\n new onset seizure,</li>\n <li>\n focal neurological deficit localizable to the central nervous system such as cranial nerve palsy, hemiparesis, aphasia or visual field defect</li>\n <li>\n papilledema</li>\n <li>\n confusion, delirium, or decreased level of consciousness.</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n clinical sepsis:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n hypotension<80mmHg systolic OR <50mmHg diastolic, AND</li>\n <li>\n At least 2 of the following four conditions:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n fever>39.0°C or <35.5°C;</li>\n <li>\n respiratory rate>20;</li>\n <li>\n heart rate >100;</li>\n <li>\n leukocyte count >12,000 cells/µl or <4000 cells/µl.</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system</li>\n <li>\n a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis</li>\n <li>\n a history of stroke or other infection of the central nervous system</li>\n <li>\n a seizure within the last 2 months</li>\n <li>\n currently taking or ever taken antiretroviral therapy</li>\n <li>\n currently taking anti-tuberculous therapy</li>\n <li>\n screen positive for tuberculosis using symptom based intensified case finding:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n cough greater than 2 weeks, and at least one of the following:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n fever</li>\n <li>\n night sweats</li>\n <li>\n noticeable weight loss</li>\n <li>\n contact with another individual with tuberculosis</li>\n <li>\n hepatomegaly</li>\n <li>\n splenomegaly</li>\n <li>\n ascites</li>\n <li>\n swelling in a single joint</li>\n <li>\n compression fracture of the spine</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n currently or recently (<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications</li>\n <li>\n pregnant or breast-feeding</li>\n <li>\n alanine aminotransferase concentration more than 3 times the upper limit of normal</li>\n <li>\n neutrophil count <1000x10³ cells/mL</li>\n <li>\n hemoglobin <8g/dL</li>\n <li>\n platelet count <100,000x 10³ platelets/mL</li>\n <li>\n creatinine clearance ≤50 ml/min</li>\n <li>\n individuals with active heavy alcohol use or active recreational drug use</li>\n</ol>\n
      • primary_end_points<p>\n  </p>\n<ol>\n <li>\n To determine the effect of fluconazole plus flucytosine as compared to fluconazole alone on <em>survival at 12 weeks</em> in antiretroviral therapy (ART)-naïve asymptomatic individuals with serum cryptococcal antigenemia and CD4 cell count<=100 cells/ml</li>\n <li>\n To evaluate the safety and tolerability profile of fluconazole plus flucytosine as compared to fluconazole alone.</li>\n</ol>\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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<p>\n  </p>\n<ol>\n <li>\n Family AIDS Care and Education Services, Lumumba Health Center\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Staff:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n Assistant Study Coordinator (Edwin Omondi): Mr. Omondi has a B.A. from Moi University and has 3 years experience working with the principal investigator, one year of experience as an Assistant Study Coordinator.</li>\n <li>\n Study Clinician (TBD): This individual will be a clinical officer with 1-2 years experience in research</li>\n <li>\n Laboratory Technician (TBD): Diploma level laboratory technician with 1-2 years clinical experience</li>\n <li>\n Research Assistants (Elizabeth Opiyo, TBD): Elizabeth Opiyo is a certified HIV antibody test counselor and has worked with the principal investigator for 3 years.  Her counterpart will need to have experience with HIV antibody test counseling and 1-2 years experience in research.</li>\n </ol>\n </li>\n <li>\n Site facilities: The study sites are housed within the compound of an urban health center.  In addition, Lumumba Health Center serves as the provincial hub for FACES and has had several clinical trials performed within the Research, Care and Training Program Facilities.  Lumumba Health Center has basic facilities including electricity with generator back-up, readily available water, and a clinical research building. In addition, there are two clinical laboratories on site that can perform full hemograms, CD4 cell counts, chemistries, malaria parasite smears, and acid-fast bacilli smears.  Although microbiological testing is not currently performed at Lumumba Health Center, as part of the capacity building work of this study, we are in the process of building capacity to conduct microbiological cultures onsite. Study activities, except laboratory testing, will be housed in a small 3 room building which has been used as a Voluntary Counseling and Testing Center approximately 30 meters from Lumumba Health Center.</li>\n <li>\n Emergency facilities: Inpatient care is available at Kisumu District Hospital or Provincial General Hospital, Kisumu.</li>\n </ol>\n </li>\n</ol>\n<p style=\"margin-left:.75in;\">\n  </p>\n<ol>\n <li value=\"2\">\n Family AIDS Care and Education Services, Suba District Hospital\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Staff:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n Assistant Study Coordinator and Study Clinician (TBD): This individual will be a medical officer with 1-2 years experience in research or a clinical officer with 3-5 years experience in research</li>\n <li>\n Laboratory Technician (TBD): Diploma level laboratory technician with 1-2 years clinical experience</li>\n <li>\n Research Assistants (2 individuals TBD): Individuals will need to have experience with HIV antibody test counseling and 1-2 years experience in research.</li>\n </ol>\n </li>\n <li>\n Site facilities: The study sites are housed within the compound of a rural district hospital with basic facilities including electricity with generator back-up, readily available water, and a clinical research building. The study will be housed in two clinical rooms within the clinical research building.  In addition, there is a clinical laboratory on site that can perform full hemograms, CD4 cell counts, chemistries, malaria parasite smears, and acid-fast bacilli smears.  Microbiological cultures will be performed at Mbita District Hospital, which has a fully functional microbiological clinical laboratory.  Mbita District Hospital is approximately 30 minute drive from Sindo.</li>\n <li>\n Emergency facilities: Inpatient care is available at Suba District Hospital.</li>\n </ol>\n </li>\n</ol>\n
      • other_details_explanation<p>\n  </p>\n<p style=\"margin-left:.1in;\">\n           This trial is not being conducted in the host country of the applicant or the sponsor.  The reason for this is that the disease being studied, early cryptococcal infection, results in a significant burden in regions of sub-Saharan Africa like Kenya with high HIV prevalence and high prevalence of cryptococcal disease.  Early cryptococcal infection does not pose a significant burden in the U.S.  Thus, while Kenyans would bear the risks associated with participating in this clinical trial, they and other individuals living with HIV in sub-Saharan African have the most potential to benefit from a new oral treatment for early cryptococcal infection.  If combination therapy with flucytosine and fluconazole shows benefit, as investigators, we are committed to working to obtain funding for a Phase III clinical trial and should the treatment show definitive benefit, to advocating for flucytosine to be registered here in Kenya and for low-cost generic flucytosine to be made available in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n  </p>\n<ol>\n <li align=\"left\">\n Kenya Medical Research Institute (KEMRI) Ethical Review Committee (ERC) and Scientific Steering Committee (SSC)\n <ol style=\"list-style-type:lower-alpha;\">\n <li align=\"left\">\n <em>Date of submission to SSC:</em> 21^st February 2012</li>\n <li align=\"left\">\n <i>ERC deferred review to UON.</i></li>\n </ol>\n </li>\n</ol>\n
      • other_details_regulatory_approved<p>\n  </p>\n<ol>\n <li>\n University of California San Francisco Committee on Human Research\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em>Approval date:</em> 11^th October 2012</li>\n <li>\n <em>Number of sites:</em> 0</li>\n </ol>\n </li>\n <li>\n Kenyatta National Hospital/ University of Nairobi Ethics Review Committee (KNH/UON ERC)\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <em>Approval date:</em> 17^th December 2012</li>\n <li>\n <em>Number of sites:</em> 1</li>\n </ol>\n </li>\n</ol>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n None.</p>\n
      • estimated_durationapproximately 20 months
      • 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_comparatorfluconazole monotherapy
      • 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_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteLumumba Health Center [min 0, max 100]\nSuba District Hospital [min 0, max 100]
      • total_participants_worldwide100
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAna-Claire
      • investigator1_middle_name
      • investigator1_family_nameMeyer
      • investigator1_qualificationMD, MSHS
      • investigator1_professional_addressFamily AIDS Care and Education Services, Box 614-40100, Kisumu Kenya
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_Yes
      • number_participants100
      • notification
      • approval_date05-01-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-02-2013
      • 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)
      • modified2014-02-19 15:05:18
      • created2013-01-25 20:47:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id8
        • application_id11
        • given_nameAna-Claire
        • middle_name
        • family_nameMeyer
        • qualificationMD MSHS
        • professional_addressFamily AIDS Care and Education Services, Box 614-40100, Kisumu Kenya
        • telephone(null)
        • email(null)
        • created2013-01-25 21:38:59
        • modified2013-02-28 23:01:00
      • 1(array)
        • id9
        • application_id11
        • given_nameJudith
        • middle_name
        • family_nameKwasa
        • qualificationMBChB, MMed
        • professional_addressLecturer, University of Nairobi, Dept Clinical Medicine and Therapeutics, Box 19676, 00202, Nairobi Kenya
        • telephone(null)
        • email(null)
        • created2013-01-25 21:45:08
        • modified2013-02-28 23:01:00
      • 2(array)
        • id10
        • application_id11
        • given_nameMark
        • middle_name
        • family_nameJacobson
        • qualificationMD
        • professional_addressPHP/UCSF, Ward 84, 995 Potrero, San Francisco, CA 94110 USA
        • telephone(null)
        • email(null)
        • created2013-01-25 21:46:59
        • modified2013-02-28 23:01:00
    • SiteDetail(array)
      • 0(array)
        • id17
        • application_id11
        • county_id42
        • site_nameFamily AIDS Care and Education Services, Lumumba Health Center
        • physical_addressBehind United Mall, Kisumu, Kenya
        • contact_details+254-716-510-197
        • contact_personEdwin Omondi
        • site_capacity(null)
        • misc(null)
        • created2013-01-25 21:38:59
        • modified2013-02-28 23:01:00
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id18
        • application_id11
        • county_id43
        • site_nameFamily AIDS Care and Education Services, Suba District Hospital
        • physical_addressSindo, Kenya
        • contact_detailsEdwin Omondi
        • contact_person+254-716-510-197
        • site_capacity(null)
        • misc(null)
        • created2013-01-25 21:56:10
        • modified2013-02-28 23:01:00
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
    • Sponsor(array)
      • 0(array)
        • id4
        • application_id11
        • sponsorNational Institute of Neurological Disorders and Stroke
        • sponsor_type(null)
        • contact_personJoanne Odenkirchen
        • address6001 Executive Boulevard, Suite 2178, Bethesda, MD 20892, USA
        • telephone_number+1-301-496-3104
        • fax_number+1-301-480-1080
        • cell_numberN/A
        • email_addressodenkirj@ninds.nih.gov
        • created2013-01-25 21:38:59
        • modified2013-02-28 23:01:00
  • 4(array)
    • Application(array)
      • id60
      • user_id51
      • trial_status_id(null)
      • abstract_of_study<p>\n  </p>\n<p>\n Controlled human malaria infection (CHMI) is an important tool for assessment of the efficacy of novel malaria vaccines and drugs.<font size=\"1\"> </font>As CHMI trials are carried out in a controlled environment, they allow unprecedented detailed evaluation of parasite growth and immunological responses, providing essential information for vaccine and drug development.</p>\n<p>\n To date, modern CHMI studies have only been performed in countries where malaria is not endemic and involved volunteers who are malaria naïve. However, CHMI studies involving volunteers with prior exposure to malaria could be a valuable tool to accelerate malaria vaccine development.</p>\n<p>\n The ability to perform CHMI studies in Africa would increase the international capacity for efficacy testing of malaria vaccines and allow earlier assessment of vaccine efficacy in the target, African population. CHMI trial centres in Africa would allow malaria endemic countries, which have the most to gain from malaria research, to influence the research agenda, to operate independently and to exercise ownership over key research pertinent to their health priorities.</p>\n<p>\n We propose to conduct a CHMI study of 28 healthy adults with varying degrees of prior exposure to malaria in Kenya. We will assess parasite growth dynamics post CHMI and examine the relationship between this and laboratory assays of functional immunity to <em>P.</em> <em>falciparum. </em></p>\n
      • study_title<p>\n  </p>\n<p>\n <strong>A pilot study to optimise controlled human malaria infections in humans with varying degrees of prior exposure to malaria using <em>P. falciparum</em> sporozoites administered by needle and syringe</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/12/12/01
      • version_no6.0
      • date_of_protocol17-11-2012
      • study_drugPurified Plasmodium Falciparum Sporozoites
      • disease_conditionMalaria
      • 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
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseajuma@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_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Elizabeth Juma
      • declaration_date111-03-2013
      • declaration_principal_investigatorDr. Bernhards Ogutu
      • declaration_date211-03-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n  </p>\n<ul>\n <li>\n Healthy adults aged 18 to 40 years.</li>\n <li>\n Minimum of 4 completed years (Form 4) of secondary education (Students in tertiary institutions will need to produce a student ID card provided by the school; other volunteers will need to produce their form 4 completion certificates).</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements.</li>\n <li>\n Informed consent to undergo CHMI.</li>\n <li>\n Answer all questions on the informed consent questionnaire correctly.</li>\n <li>\n Willingness to take a course of curative anti-malaria medication.</li>\n <li>\n Agreement to stay in an in-patient unit during a part of the study (from day of administration of PfSPZ Challenge until completion of curative course of atovaquone/ proguanil hydrochloride given either at malaria diagnosis or day 21 post administration of PfSPZ Challenge).</li>\n <li>\n Use of effective method of contraception for duration of study (women only).</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n  </p>\n<ul>\n <li>\n PCR positive for <em>P. falciparum</em> parasites at screening.</li>\n <li>\n Use systemic antibiotics with known antimalarial activity within 30 days of administration of PfSPZ Challenge (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).</li>\n <li>\n Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of enrolment.</li>\n <li>\n Prior receipt of an investigational malaria vaccine.</li>\n <li>\n Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).</li>\n <li>\n Use of immunoglobulins or blood products within 3 months prior to enrolment.</li>\n <li>\n Haemoglobinopathy (sickle-cell trait) deemed to interfere with study endpoints</li>\n <li>\n A history of allergic disease or reactions likely to be exacerbated by malaria infection.</li>\n <li>\n Contraindications to atovaquone/proguanil hydrochloride.</li>\n <li>\n History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).</li>\n <li>\n History of serious psychiatric condition that may affect participation in the study.</li>\n <li>\n Any other serious chronic illness requiring hospital specialist supervision.</li>\n <li>\n Women only; pregnancy, intention to become pregnant or breast-feeding during study.</li>\n <li>\n Suspected or known current alcohol abuse.</li>\n <li>\n Suspected or known injecting drug abuse.</li>\n <li>\n Seropositive for hepatitis B surface antigen (HBsAg).</li>\n <li>\n Seropositive for hepatitis C virus (antibodies to HCV) with PCR positive for Hepatitis C.</li>\n <li>\n Positive family history in 1st and 2nd degree relatives < 50 years old for cardiac disease.</li>\n <li>\n Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.</li>\n <li>\n Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n  </p>\n<p>\n <strong>Primary Endpoint </strong></p>\n<p>\n The infectivity of PfSPZ Challenge in healthy Kenyan adults assessed using thick film microscopy and highly sensitive PCR for <em>P. falciparum</em> DNA.</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Endpoint</strong></p>\n<p>\n Volunteers’ natural immunity to <em>P. falciparum </em>assessed by comparing parasite growth dynamics between volunteers with maximum and minimal prior exposure to malaria following CHMI. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPotential Vaccine Candidate
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<p>\n <strong>Site:</strong> KEMRI-CCR has a well-equipped in-patient facility for clinical trials with 12 nursing officers and laboratory personnel. It has emergency resuscitation facilities but will rely on Nairobi hospital for emergency care if needed.</p>\n<p>\n <strong>Core Study team:</strong></p>\n<p>\n Dr. Susanne Sheehy, MBChB, MRCP, DTM&H (PhD Student and Vaccine Research Fellow)</p>\n<p>\n Dr. Elizabeth Juma MBChB, MMed (Study Coordinator), Clinical Trialist</p>\n<p>\n Dr. Patricia Njuguna MBChB, MMed (Clinical Trials Coordinator, KEMRI-WT Kilifi, PI RTS,S vaccine study</p>\n<p>\n Dr. Faith Osier, MBChB, MRCP, PhD (Clinical Immunologist)</p>\n<p>\n Dr. Catherine Molyneux, PhD (Social Scientist)</p>\n<p>\n <strong>Laboratories</strong></p>\n<p>\n KEMRI-Wellcome Trust Centre in Kilifi will conduct all immunological studies</p>\n
      • other_details_explanation<p>\n  </p>\n<p style=\"margin-left:.5in;\">\n <span style=\"font-family:arial,helvetica,sans-serif;\">The study is being conducted in Kenya and not in the UK because:</span></p>\n<p style=\"margin-left:.5in;\">\n <span style=\"font-family:arial,helvetica,sans-serif;\">1. The disease of interest is not a public health problem in the sponsor’s host country. Efforts to develop novel control measures must ultimately be developed in endemic countries among populations likely to benefit from them</span></p>\n<p style=\"margin-left:.5in;\">\n <span style=\"font-family:arial,helvetica,sans-serif;\">2. Of building KEMRI'sinstitutional capacity to conduct controlled human malaria infections and phase 1 vaccine trials</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n  </p>\n<p class=\"Default\" style=\"margin-top:5.0pt;margin-right:7.0pt;margin-bottom:6.0pt;\nmargin-left:.5in;text-align:justify\">\n <span style=\"font-size:11.5pt\">Kenya Medical Research Institute Ethics Research Committee 18th January 2013<o:p></o:p></span></p>\n<p class=\"Default\" style=\"margin-top:5.0pt;margin-right:7.0pt;margin-bottom:6.0pt;\nmargin-left:.5in;text-align:justify\">\n <span style=\"font-size:11.5pt\">Oxford Tropical Research Ethics Committee REF: 161-12 29^th November 2012 <o:p></o:p></span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration12 months with 3 months of follow-up for study participants
      • 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_areaKenya Medical Research Institute, Centre for Clinical Research, Nairobi
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site28
      • total_participants_worldwide28
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB, MMed, PhD
      • investigator1_professional_addressKenya Medical Research Institute – Centre for Clinical Research, P. O. Box 20778-00200 Nairobi
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_No
      • number_participants28
      • notification<p>\n None</p>\n
      • approval_date18-01-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-03-2013
      • 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)
      • modified2013-04-05 11:39:28
      • created2013-03-07 14:55:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id34
        • application_id60
        • given_nameBernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MMed, PhD
        • professional_addressKenya Medical Research Institute – Centre for Clinical Research, P. O. Box 20778-00200 Nairobi.
        • telephone(null)
        • email(null)
        • created2013-03-07 14:58:42
        • modified2013-03-12 12:41:08
      • 1(array)
        • id36
        • application_id60
        • given_nameKevin
        • middle_name
        • family_nameMarsh
        • qualificationMBChB, MCRP, DTMH
        • professional_addressKEMRI and Wellcome Trust Centre for Geographical Medicine Coast, Kilifi
        • telephone(null)
        • email(null)
        • created2013-03-07 15:09:22
        • modified2013-03-12 12:41:08
    • SiteDetail(array)
      • 0(array)
        • id51
        • application_id60
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-03-07 14:58:42
        • modified2013-03-12 12:41:08
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id28
        • application_id60
        • sponsorUniversity of Oxford
        • sponsor_type(null)
        • contact_personElaine Chick, Deputy Head of Clinical Trails and Research Governance
        • addressClinical Trials and Research Governance, Joint Research Office, Block 60 Churchill Hospital. Oxford OX3 7LE, United Kingdom
        • telephone_number+44 1865 572246
        • fax_number+44 1865 572228
        • cell_number+44 1865 572246
        • email_addressheather.house@admin.ox.ac.uk
        • created2013-03-07 14:58:42
        • modified2013-03-12 12:41:08
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $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