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• applications(array)
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    • Application(array)
      • id496
      • user_id73
      • trial_status_id5
      • abstract_of_study<p>\n Real-time electronic monitoring is the optimal approach for understanding patterns of adherence, which is critical for determining if adherence to daily oral pre-exposure prophylaxis (PrEP) aligns with an individual’s risk for HIV acquisition. Compared with earlier adherence measurement devices, next generation Wisepill technology offers significant innovations in data storage and transmission reliability, cost, and usability and is ready for implementation in resource-limited settings. Coupling Wisepill monitoring to SMS adherence reminders has great potential to support adherence at the precise time it is needed. Real-time strategies may be particularly important for young women- a population in need of self-controlled HIV prevention strategies, but one that has previously struggled with PrEP adherence. Triangulating weekly SMS measurement of sexual behavior with adherence may explain how PrEP can be used most effectively for HIV prevention (i.e., prevention-effective adherence).</p>\n<p>\n This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.</p>\n<p>\n <strong>Design</strong>:  Prospective study of open-label PrEP</p>\n<p>\n                 Randomization (1:1) of SMS reminders on PrEP adherence</p>\n<p style=\"margin-left:.5in;\">\n Periodic surveys of risk behavior and perception, including by weekly SMS</p>\n<p style=\"margin-left:.5in;\">\n Two years of follow-up per participant</p>\n<p>\n <strong>Population: </strong>Young women at high risk for HIV infection who are interested in taking PrEP </p>\n
      • study_title<h3>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Next generation real-time monitoring for PrEP adherence in young Kenyan women</strong></span></h3>\n
      • laymans_summary<p>\n <span style=\"color: rgb(0, 0, 0); font-size: 11pt; font-family: Arial, sans-serif;\">Pre-Exposure Prophylaxis (PrEP) is a new anti-retroviral based HIV prevention method. It works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize strategies that will enhance compliance, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to an already-burdened public health infrastructure and the ability of health systems to maximize PrEP use will necessitate finding novel strategies that would encourage and enhance adherence. Additionally, there exist major barriers to PrEP use, which includes stigma, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. </span><span style=\"color: rgb(0, 0, 0); font-family: Arial, sans-serif; font-size: 11pt;\">This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women.</span></p>\n
      • short_titleMonitoring Pre-exposure Prophylaxis for Young Adult women (MPYA)
      • protocol_noECCT/16/05/02
      • version_no2.0
      • date_of_protocol19-04-2016
      • study_drugEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada) - MPYA Study
      • disease_conditionPrEP for HIV Prevention in Young Women
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEmtricitabine/Tenofovir Disoproxil Fumarate (Truvada)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
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      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Kenneth Ngure
      • declaration_date117-05-2016
      • declaration_principal_investigatorDr Nelly R. Mugo
      • declaration_date217-05-2016
      • placebo_presentNo
      • study_objectives<p>\n <strong>Aim 1.</strong> <u>Use the next generation Wisepill device in a cohort of young HIV-uninfected Kenyan women initiating PrEP to a) measure real-time adherence and b) determine the impact of SMS reminders on adherence</u>. We will monitor adherence among all women with Wisepill. We will randomize half to receive daily SMS reminders with the option of switching to SMS reminders only as triggered by missed doses; the other half will receive no SMS reminders. There will be two primary outcomes for this aim. First, we will determine enacted adherence (i.e., pill taking) and persistence (i.e., continuation of PrEP over time) as determined by Wisepill from initiation of PrEP use (when adherence patterns are often established) through 24 months of use, comparing those randomized or not to SMS reminders. Second, we will compare dried blood spot (DBS) tenofovir-diphosphate levels between the two groups at multiple time points. With both outcomes, we will be assessing the synergy of SMS reminders coupled to real-time monitoring.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 2. </strong><u>Determine the technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders.</u> We will measure data transmission reliability, battery life, and other technical features through the two-year cohort study. We will assess acceptability and usability of our strategy via quantitative surveys in all women, as well as qualitative interviews in about 50 women. We will additionally assess costs and ease of use with a time and motion study. Using these cost estimates and adapting an existing mathematical model of HIV transmission, we will estimate the cost-effectiveness of Wisepill plus the SMS reminders per HIV case averted. Adherence validity will be determined by comparing the Wisepill data with DBS tenofovir levels as measured in Aim 1. Discrepancies between the two measures will be explored through qualitative interviews at the conclusion of the study.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 3. </strong><u>Triangulate Wisepill adherence data with weekly assessment of HIV risk behaviors and perceptions, to measure prevention-effective adherence.</u> After the first 6 months of PrEP use (i.e., when initial decisions about PrEP may start to change), we will send all women a weekly SMS survey asking about recent sexual behavior, use of alternate HIV prevention tools, subjective HIV risk, and perception of their PrEP adherence. We will explore the overlap of perceptions and behaviors and PrEP adherence, through quantitative surveys in all women and qualitative interviews in about 50 women. Our goal is to measure dynamic changes in HIV risk and perception of risk or other motivators for HIV prevention that may lead to PrEP discontinuation (appropriately or inappropriately). We will use these SMS surveys to quantify prevention-effective adherence in young women at risk for HIV infection (individually and for the cohort overall). At exit from the study, we will administer a short questionnaire to understand future plans to use PrEP and experiences related to PrEP during the study.</p>\n<p>\n  </p>\n<p>\n <strong>Aim 4</strong>. To qualitatively determine why young women in Kenya who are at risk for HIV acquisition may choose not to enroll in a PrEP study or initiate PrEP as it relates to views on PrEP and the impact of technology on study involvement. We will interview up to 60 women who met eligibility criteria at screening but do not return for enrollment. We will also conduct at least 10 and up to 12 focus groups among five key populations across the two sites. These focus groups will include: key community leaders, male parents, female parents, young women (ages 18-24 who are not participating in the larger study), and young men (ages 18-24) from the community, assuming one focus group with each population at each site. We are allowing for one additional focus group per site in case of technical difficulties with the digital recorders or other data collection difficulties. Inquiry will be guided by domains from a prior conceptual model we have developed focused on understanding decision-making related to uptake of HIV treatment for prevention, as well as prior research on PrEP uptake and adherence. We will use an iterative approach over the course of data collection.</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:31.7pt;\">\n ·   Female</p>\n<p style=\"margin-left:31.7pt;\">\n ·   HIV-uninfected (as determined by Kenya national testing algorithms)</p>\n<p style=\"margin-left:31.7pt;\">\n ·   Age 18-24 years</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Wanting to start PrEP with an initial recommendation of 6 months of use</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Clinically safe to receive PrEP, in accordance with CDC guidelines:</p>\n<ul>\n <li style=\"margin-left: 31.5pt;\">\n  Creatinine clearance >60 mL/min</li>\n <li style=\"margin-left: 31.5pt;\">\n   Not infected with hepatitis B</li>\n <li style=\"margin-left: 31.5pt;\">\n   No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study</li>\n</ul>\n<p style=\"margin-left:1.0in;\">\n ·   Sexually active (defined as vaginal or anal sex) within the last 3 months</p>\n<p style=\"margin-left:1.0in;\">\n ·   At high risk for HIV infection based on a score of <u>></u>5 or being in an HIV serodiscordant relationship</p>\n<p style=\"margin-left:31.5pt;\">\n ·   Not pregnant</p>\n<p style=\"margin-left:1.0in;\">\n ·   Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it</p>\n<p style=\"margin-left:1.0in;\">\n ·   Intending to stay in the area for at least the next year</p>\n
      • principal_exclusion_criteria<p style=\"margin-left: 85.5pt;\">\n Unable to provide consent</p>\n<p style=\"margin-left: 85.5pt;\">\n Breast-feeding (Truvada is not currently approved for use during breast-feeding)</p>\n<p style=\"margin-left: 85.5pt;\">\n Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.</p>\n
      • primary_end_points<p>\n Determining adherence to PrEP using Wisepill monitoring device and SMS reminders.</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 style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Partners in Health & Research Development Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists and laboratory technologists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Njambi Njuguna  MBChB, MSc, MPH</p>\n
      • other_details_explanation<p>\n In resource-limited settings, cell phones are common and have great potential for adherence intervention when coupled to real-time adherence monitoring. In Kenya, ~30 million people (70% of the population) own cell phones, and mobile technology for health (mHealth) is rapidly developing. Two landmark randomized controlled trials of SMS reminders in Kenya showed significant increases in ART adherence and one showed an increase in viral suppression. Studies assessing real-time adherence interventions are needed for PrEP. </p>\n<p>\n The next generation Wisepill technology offers significant innovations compared with the first generation and has the potential for ready implementation in resource-limited settings, for both research and clinical use.</p>\n<p>\n Wisepill (Figure 1) is a promising emerging technology poised for high impact in understanding adherence through real-time day-to-day measurements of pill taking behavior. A beta-development form of Wisepill has been available for several years; initial limitations included unreliable data transmission, limited battery life, and a challenging user interface in diverse settings (personal communication from Dr. Rivet Amico and Dr. Mirjam Kempf-Collette). Through our prior experience with this device, we are well positioned to test the newly refined next generation technology such that it is “plug and play” and ready for widespread use in research and potentially clinical care.</p>\n<p>\n In the FEM-PrEP and VOICE trials (which involved at-risk women in Kenya, South Africa, Tanzania, Uganda, and Zimbabwe), <30% of participants had objective evidence of PrEP adherence, and no efficacy of PrEP against HIV found as a result. Those data have made some question whether PrEP works for women.  However, in the Partners PrEP (KNH/UoN ERC ref. # P286/05/2012) and TDF2 trials (which involved serodiscordant couples in Kenya and Uganda and heterosexual men and women in Botswana, respectively), women did adhere well to PrEP, and PrEP prevented HIV in subgroups of young, high-risk women, proving that PrEP is efficacious for women when taken. Work done after the VOICE trial suggests that multiple factors contributed to low adherence in that study, including complex perceptions of self-efficacy against HIV risk, HIV and HIV prevention stigma, and components of the clinical trial itself (e.g., blinding, uncertainty about efficacy). </p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington IRB - May 2016</p>\n<p>\n Massachusetts General Hospital (MGH) - May 2016</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) ERC - Approved two sites (Thika & Kisumu)</p>\n<p>\n                                                                                          Approved on May4, 2016 (Thika)</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration4 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
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      • design_controlled_other_medicinal
      • design_controlled_placebo
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      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
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      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site175
      • total_participants_worldwide350
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJessica
      • investigator1_middle_name
      • investigator1_family_nameHaberer
      • investigator1_qualificationMD, MS
      • investigator1_professional_addressMassachusetts General Hospital/Harvard Medical School, Boston USA
      • investigator1_telephone+1 617 724 0351
      • investigator1_emailJHABERER@mgh.harvard.edu
      • organisations_transferred_Yes
      • number_participants350
      • notification
      • approval_date07-09-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-02-2020
      • is_child0
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      • initial_date_submitted(null)
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      • approved2
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-05 12:59:48
      • created2016-05-11 10:11:00
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id328
        • application_id496
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
    • SiteDetail(array)
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        • id391
        • application_id496
        • county_id22
        • site_nameThika Partners Study Clinic (Partners in Health Research and Development)
        • physical_addressOAU Road, Near Thika Nursing Home, Thika Section 9
        • contact_detailsP.O Box 19865-00202
        • contact_personDr. Kenneth Ngure
        • site_capacity(null)
        • misc(null)
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id392
        • application_id496
        • county_id42
        • site_namePartners in Prevention, Kisumu Site
        • physical_addressAgoi Street
        • contact_detailsP.O Box 614-40100
        • contact_personJosephine B. Odoyo
        • site_capacity(null)
        • misc(null)
        • created2016-05-11 13:20:12
        • modified2020-02-07 17:01:35
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id260
        • application_id496
        • sponsorMassachusetts General Hospital/Harvard Medical School & University of Washington
        • sponsor_typeResearch Institution
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067-22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2016-05-11 11:05:36
        • modified2020-02-07 17:01:35
  • 1(array)
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      • id495
      • user_id77
      • trial_status_id5
      • abstract_of_study<p>\n This is a phase II open-label, single arm, multicenter, steady-state pharmacokinetic (PK) study of drug-drug interactions in Human Immunodeficiency Virus (HIV) infected women treated with depot medroxyprogesterone acetate (DMPA) while receiving an efavirenz (EFV)-based combination antiretroviral therapy (cART), rifampicin (RIF) and isoniazid (INH) during the treatment of active tuberculosis (TB). The objectives of this study are to estimate the optimal dosing frequency of depot medroxyprogesterone acetate (DMPA) for HIV and TB coinfected women taking EFV-based cART and RIF-containing TB treatment based on a target MPA concentration >0.1 ng/mL and to determine whether a 150 mg DMPA IM injection will be adequate to suppress ovulation through 12 weeks in women taking EFV-based cART and RIF-containing TB treatment based on serial plasma progesterone concentrations. Premenopausal women 18 to 46 years of age who are co-infected with HIV and TB and are on EFV plus two or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 4 weeks and intend to continue on this regimen without modifications for the duration of the study will participate. The women must also be on the continuation phase of active TB treatment taking RIF and INH on a 5-day or more per week schedule. Blood samples for DMPA PK analysis will be collected at pre-dose and every 2 weeks post DMPA administration. Progesterone levels will be tested every 2 weeks post DMPA administration. Depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly (IM) as a single-dose at study entry and an optional dose of DMPA will be available at no cost to all qualifying study participants after all week 12 study evaluations are completed. The sample size will comprise 46 evaluable participants who will be followed for 12 weeks The results of this study, if successful, will help inform the optimal frequency of DMPA injections in HIV/TB co-infected patients.</p>\n
      • study_title<div>\n A5338</div>\n<div>\n An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among</div>\n<div>\n Depot Medroxyprogesterone Acetate (DMPA), Rifampicin (RIF), and Efavirenz</div>\n<div>\n (EFV) in Women Co-Infected with Human Immunodeficiency Virus (HIV) and</div>\n<div>\n Tuberculosis (TB)</div>\n
      • laymans_summary<p>\n Effective contraception is critical to young women with HIV-associated tuberculosis (TB), as unintended pregnancy is associated with increased maternal illness and death. The effects of co-administration of efavirenz and rifampicin on the mechanisms of action of depot medroxyprogesterone acetate (DMPA) are unknown. We hypothesized that clearance of medroxyprogesterone acetate (MPA) would increase when given with rifampicin and efavirenz, thus increasing risk of pregnancies. This pharmacokinetics (PK) study assessed DMPA among HIV/TB coinfected women on an efavirenz-based antiretroviral treatment and rifampicin-based TB treatment. Plasma MPA concentrations and progesterone were measured before dosing (MPA only) and 2, 4, 6, 8, 10, and 12 weeks after a single DMPA 150 mg intramuscular injection. The primary outcome measure, MPA concentration (less than 0.1 ng/mL) at week 12, was assessed and the parameters of MPA mechanism of action were calculated using statistical analysis. Among 42 evaluable women from 5 African countries, median age was 32 years and median CD4 was 414 cells/ mm3. Five women had MPA less than 0.1 ng/mL at week 12; of these, one had MPA less than 0.1 ng/mL at week 10. The median clearance of MPA was 19 681 L/week compared with 12 118 L/week for historical controls. There were no adverse events related to DMPA, and progesterone concentrations were less than 1 ng/mL for all women for the study duration. In conclusions, DMPA when given with rifampicin and efavirenz, was safe. MPA clearance was higher than in women with HIV and not on any Anti-HIV treatment suggesting that more frequent DMPA dosing might be needed.</p>\n
      • short_titleA5338
      • protocol_noECCT/16/05/01
      • version_noVersion 1.0
      • date_of_protocol12-12-2014
      • study_drugDMPA
      • disease_conditionHIV and TB
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_namemedoxyprogesterone acetate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_investigators_cv1
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      • applicant_approval_letter0
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      • applicant_participating_countries0
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      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantElizabeth A. Ayuo
      • declaration_date109-05-2016
      • declaration_principal_investigatorDr. David Schnabel
      • declaration_date209-05-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or</div>\n<div>\n chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry</div>\n<div>\n and confirmed by a licensed Western blot or a second antibody test by a </div>\n<div>\n <div>\n Currently receiving RIF and Isoniazid (INH)-based TB therapy on at least 5 days</div>\n <div>\n per week schedule after completion of the intensive phase of TB treatment</div>\n <div>\n (minimum of 8 weeks of TB treatment) and expected to be on TB treatment for a</div>\n <div>\n minimum of 12 weeks after enrollment.</div>\n <div>\n 4</div>\n</div>\n<div>\n <div>\n Last menstrual period (LMP) ≤35 days prior to study entry.</div>\n <div>\n 4.1.6.1 If LMP is >35 days prior to study entry, serum follicle-stimulating</div>\n <div>\n hormone (FSH) must be ï‚£40 MIU/mL.</div>\n <div>\n NOTE: Enrollment after the start of the monthly menstrual flow is preferred.</div>\n <div>\n 4.1.7 Negative serum or urine-HCG pregnancy test within 30 days prior to study entry</div>\n <div>\n and negative pregnancy test at entry at any network-approved laboratory that</div>\n <div>\n operates in accordance with Good Clinical Practices and participates in</div>\n <div>\n appropriate external quality assurance programs.</div>\n <div>\n 4.1.8 All participants must agree not to participate in a conception process (eg, active</div>\n <div>\n attempt to become pregnant or in vitro fertilization) for the duration of the study.</div>\n <div>\n Women of reproductive potential, who are participating in sexual activity that</div>\n <div>\n could lead to pregnancy, must agree to use an additional reliable method of</div>\n <div>\n contraception while in the study. Acceptable forms of contraceptives include:</div>\n <div>\n ï‚· Condoms (male or female) with or without a spermicidal agent</div>\n <div>\n ï‚· Diaphragm or cervical cap with spermicide</div>\n <div>\n ï‚· Non-hormonal IUD</div>\n <div>\n ï‚· Bilateral tubal ligation</div>\n <div>\n ï‚· Male partner vasectomy</div>\n <div>\n 4.1.9 Laboratory values within 30 days prior to study entry:</div>\n <div>\n ï‚· Absolute neutrophil count ≥500 cells/mm3</div>\n <div>\n ï‚· Platelet count ≥50,000 platelets/mm3</div>\n <div>\n ï‚· Hemoglobin ≥8.0 g/dL</div>\n <div>\n ï‚· Aspartate transaminase (AST) and alanine aminotransferase (ALT) <5 x</div>\n <div>\n upper limit of normal (ULN)</div>\n <div>\n ï‚· Creatinine ≤1.5 x ULN</div>\n <div>\n ï‚· Total bilirubin ≤2.0 x ULN</div>\n <div>\n  Women between the ages of 18 to 46 years</div>\n <div>\n  Ability and willingness to provide written informed consent</div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n Receipt of DMPA and any other injectable contraceptives within 180 days prior to</div>\n<div>\n study entry.</div>\n<div>\n 24 A5338</div>\n<div>\n Final Version 1.0</div>\n<div>\n 12/12/14</div>\n<div>\n 4.2.2 Receipt of other hormonal contraceptives within 30 days prior to study entry.</div>\n<div>\n 4.2.3 Use of any drugs other than RIF and EFV known to: 1) induce CYP3A4 system</div>\n<div>\n within 30 days and to 2) inhibit the CYP3A4 system with one week prior to study</div>\n<div>\n entry.</div>\n<div>\n 4.2.4 ≤40 kg in weight.</div>\n<div>\n 4.2.5 Bilateral oophorectomy.</div>\n<div>\n 4.2.6 Less than 30 days postpartum at study entry.</div>\n<div>\n 4.2.7 Hypersensitivity to DMPA, MPA, or any of the other ingredients in DMPA.</div>\n<div>\n 4.2.8 Breast cancer.</div>\n<div>\n 4.2.9 Serious illness requiring systemic treatment and/or hospitalization within 21 days</div>\n<div>\n prior to study entry.</div>\n<div>\n 4.2.10 Karnofsky performance score <70 within 14 days prior to study entry.</div>\n<div>\n 4.2.11 Use of any immunosuppressant medication including systemic corticosteroids</div>\n<div>\n within 30 days prior to study entry.</div>\n<div>\n NOTE: Use of systemic or inhaled corticosteroids, such as for acute therapy for</div>\n<div>\n Pneumocystis jiroveci pneumonia (previously called Pneumocystis carinii</div>\n<div>\n pneumonia; PCP) or asthma exacerbation or TB Immune Reconstitution</div>\n<div>\n Inflammatory Syndrome (IRIS), and prednisone ≤10 mg (or equivalent) is</div>\n<div>\n permitted as a stable or tapering dose.</div>\n<div>\n 4.2.12 Active drug or alcohol use or dependence that, in the opinion of the site</div>\n<div>\n investigator, would interfere with adherence to study requirements.</div>\n<div>\n 4.2.13 History of deep venous thrombosis or pulmonary emboli</div>\n
      • primary_end_points<div>\n MPA concentration levels obtained at 2, 4, 6, 8, 10, and 12 weeks after DMPA is</div>\n<div>\n administered. The 12 week measurement will be the measurement obtained</div>\n<div>\n closest to 84 days after DMPA is administered. The allowable window for the</div>\n<div>\n measurement is ±7 days, as stated in section 6.2.3.</div>\n<div>\n Plasma progesterone levels obtained at 2, 4, 6, 8, 10, and 12 weeks after DMPA</div>\n<div>\n is administered.</div>\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_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Dr. David Schnabel MPH</p>\n<p>\n Dr. Eunice Akinyi Ouma MD</p>\n<p>\n Dr. kevin P. Cain MD</p>\n<p>\n Mr. Francis Mbata Angira </p>\n
      • other_details_explanation<p>\n Phase 1 was done in the sponsor's country.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU - 25th April 2016</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • 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_areaKISUMU CRS
      • single_site_physical_addressJOOTRH GROUNDS , CLINICAL RESEARCH CENTRE
      • single_site_contact_personDR. DAVID SCHNABEL
      • single_site_telephone+254703485481
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4 Sites
      • number_of_sites
      • multi_country_listSouth Africa - Durban CRS, Parirenyatwa, University of Wittswatersrand\nGaborone - Botswana CRS
      • data_monitoring_committeeYes
      • total_enrolment_per_site10 participants
      • total_participants_worldwide46 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid
      • investigator1_middle_name
      • investigator1_family_nameSchnabel
      • investigator1_qualificationMPH
      • investigator1_professional_addressKisumu CRS, JOOTRH Grounds, Box 1578, Kisumu 40100
      • investigator1_telephone+254703485481
      • investigator1_emaildschnabel@cdc.gov
      • organisations_transferred_No
      • number_participants10 participants
      • notification<p>\n we have requested for an expedited review. Attached evidence of payment of 2000 USD</p>\n
      • approval_date28-07-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-05-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This was a 12-week, phase II, open-label, single-arm, study of steady-state PK interactions among women coinfected with HIV and TB receiving EFV-based cART and RIF-based anti-TB Treatment. Among 42 PK-evaluable women from Kenya (10) South Africa (20), Botswana (6) and Zimbabwe (6) , median age was 32 years and median CD4 was 414 cells/mm3. Five women (11.9%; 95% CI, 4.0–25.6%) had MPA <0.1 ng/mL at week 12; of these, one had MPA <0.1 ng/mL at week 10. The median clearance of MPA was 19 681 L/week compared with 12 118 L/week for historical controls. There were no adverse events related to DMPA, and progesterone concentrations were <1 ng/mL for all women for the study duration. DMPA, when given with rifampicin and efavirenz, was safe. MPA clearance was higher than in women with HIV not on ART, leading to subtherapeutic concentrations of MPA in 12% of women, suggesting that more frequent dosing might be needed.</p>\n
      • implication_results<p>\n Since Depot Medroxyprogesterone (DMPA) clearance was higher in women on concurrent Rifampicin and Efavirenz treatment than in women with HIV and not on ART, more frequent DMPA dosing might be needed to prevent unintended pregnancies which studies have associated with increased perinatal morbidity and mortality. There is however need to conduct Phase 3 trials to see if these findings are consistent and replicable</p>\n
      • quantity_importedPlease check A5338 Drug AC
      • quantity_dispensedPlease check A5338 Drug AC
      • quantity_destroyedPlease check A5338 Drug AC
      • quantity_exportedPlease check A5338 Drug AC
      • balance_site0
      • final_date0000-00-00
      • modified2020-09-22 08:28:46
      • created2016-05-09 09:58:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id327
        • application_id495
        • given_nameDavid
        • middle_name
        • family_nameSchnabel
        • qualificationMPH
        • professional_addressKisumu CRS , JOOTRH Grounds, Box 1578, Kisumu 40100
        • telephone+254703485481
        • emaildschnabel@cdc.gov
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
    • SiteDetail(array)
      • 0(array)
        • id390
        • application_id495
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id259
        • application_id495
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_person
        • addressDrban 4001
        • telephone_number27315663933
        • fax_number
        • cell_number27315663933
        • email_addressmnggibisa@ecarefoundation.com
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
  • 2(array)
    • Application(array)
      • id492
      • user_id331
      • trial_status_id8
      • abstract_of_study<p>\n <strong>Rationale: </strong>Tungiasis, a parasitic skin disease (sand flea disease) inflicts pain and suffering on millions of people in Sub-Saharan Africa and South America, and yet it gets little attention from donors, scientists, governments and even health workers. There is no highly effective, widely available, safe and simple treatment. Instead communities in their desperation remove the embedded fleas using unsterilized pins and plant thorns which carry huge risk of secondary infection with bacteria and possibly even HIV and Hepatitis B. The government of Kenya currently recommends the use of potassium permanganate and Vaseline, but this has been demonstrated in a recent trial to have only 39% efficacy. Some communities use their own herbal remedies for sand flea control. In Kilifi County, a mix of natural products based mostly on neem oil (<em>Azadirachta indica</em>),<em>)</em> and coconut oil (<em>Cocos nucifera</em>) known as JIGFIX, is used by local community self-help groups. Coconut oil is widely used in the food and cosmetics industry and neem oil as an antiseptic, and used for medical and agricultural insect control. Their safety and beneficial properties have been shown in various contexts. Their combined effect on pathology, bacteria, fungi or insects has never been tested scientifically.</p>\n<p>\n <strong>Primary Objective: </strong>To determine whether a mix of neem and coconut oils kills a higher proportion of embedded jiggers than the current standard of potassium permanganate and Vaseline, in 7 days.</p>\n<p>\n <strong>Secondary Objectives: </strong></p>\n<p>\n ·         To determine whether neem and coconut oil reduces inflammation, pain and itching better than the standard treatment, in 7 days.</p>\n<p>\n ·          To determine the safety of the neem and coconut oil mix for topical use.</p>\n<p>\n <strong>Methods: </strong>The study will follow a randomized controlled trial design. Fifty school children aged 6-14 years with at least one clear live, embedded flea at stage II and III in each foot will be enrolled. One foot will be treated with the neem and coconut oil mix and the other with potassium permanganate. The study will take place in Malindi Sub-County of Kilifi County. The embedded fleas of each participant will be monitored every other day for 7 days after treatment using a digital handheld microscope for signs of viability, abnormal development and inflammation. The children will also be asked to assess their level of pain and itching, the major symptoms caused by embedded fleas.</p>\n<p>\n <strong>Application of Results: </strong>If the neem and coconut oil mix proves to be more effective at killing embedded fleas than the current standard of potassium permanganate, this study will have huge implications, not only for Kenya, but also for all countries where jiggers are endemic. The neem and coconut oil mix will be the only effective, safe and simple treatment available.</p>\n
      • study_title<p>\n Phase IIA, randomised controlled trial of a locally-made, herbal remedy (neem & coconut oil) for treatment of jiggers (<em>Tunga penetrans</em>)</p>\n
      • laymans_summary(null)
      • short_titleClinical trial of neem & coconut oils for tungiasis
      • protocol_noECCT/16/05/03
      • version_no1
      • date_of_protocol30-04-2016
      • study_drugHerbal: neem and coconut oils
      • disease_conditiontungiasis
      • 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_nameAzadirachtins and other limonoids (active ingredients in neem oil)
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressufillinger@icipe.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDan Masiga
      • declaration_date104-05-2016
      • declaration_principal_investigatorUlrike Fillinger
      • declaration_date204-05-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n ·         Children age 6-14 years, both male and female.</p>\n<p>\n This age group is targeted as the age most affected by jiggers and also able to give assent for participation in the study.</p>\n<p>\n ·         With one or two viable, embedded sand flea of stage IIa-IIIa of the Fortaleza classification, on both feet.</p>\n<p>\n In IIa the sand flea is already completely embedded in the skin of the host and has started to grow (hypertrophy). Lesions in stage IIIa correspond to a fully developed parasite with a characteristic watchglass-like appearance. In this stage the female sand flea starts to expel eggs. In stage IIIb egg expulsion stops, thereafter the sand flea dies and the lesion changes into stage IV. Thus, sand fleas in stage IIa – IIIa are most suitable to assess viability and alterations in the normal development of the parasites.</p>\n<p>\n The inclusion criterion for an eligible lesion will be the presence of at least 2 out of 3 viability signs at the baseline examination: expulsion of eggs, excretion of a liquid faeces or faecal threads, pulsations/ contractions of the parasite. Viability signs will be determined using a handheld digital video microscope (portable dnt DigiMicro Mobile).</p>\n<p>\n ·         Availability of a caregiver over the age of 18 years to sign the consent forms. Caregivers of selected children will be requested to attend school to sign the consent forms.</p>\n
      • principal_exclusion_criteria<p>\n Children with too few or too many lesions to be included in the study will be excluded and immediately treated with the government standard. If the neem and coconut oil mix proves to be more efficacious, these children will be treated with the neem and coconut oil mix as soon as possible (quick analyses will be conducted to enable this to be within one month) should their infections not have cleared. If several eligible lesions are present on one foot, only those (at most two) that allow a clear discernment of the developmental stage of the embedded parasite and a quantification of the inflammatory response around the lesion will be selected for data analysis. Lesions occurring in a cluster and lesions which the patient has attempted to manipulate will not be selected for data analysis.</p>\n<p>\n Patients with the presence of gross inflammation, abscess or ascending lymphangitis or lymphedema on either foot will also be excluded. Children with such complications of tungiasis will be referred to the nearest health facility for treatment. </p>\n
      • primary_end_points<p>\n The embedded fleas will be assessed at baseline and every 2^nd day for 7 days for the four viability signs (expulsion of eggs, excretion of faecal thread, excretion of faecal liquid, pulsations/contractions) using the digital handheld video microscope. The observation of each of these signs will be recorded in the case Report Form (Annex 2).</p>\n<p>\n The <strong>primary efficacy parameter</strong> will be the proportion of viable embedded sand fleas which lose viability signs after seven days of follow-up. An embedded sand flea will be considered to be non-viable when none of the four viability signs are detected during 15 minutes of observation on two consecutive follow-up examinations.</p>\n<p>\n Each lesion will be photographed using a macro lens and flash at each assessment.</p>\n<p>\n In addition a <strong>secondary efficacy parameter</strong> will be abnormal development of the embedded sand flea; no increase in size, discolouring or desiccation of the abdominal rear cone.</p>\n<p>\n The observation units will be single sand flea lesions.</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_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 Study Co-PI/ Field coordinator-Lynne Elson, PhD, MPH-10 years experience as  independent consultant in Public Health, 12 years experience in tropical disease research, 3 years experience in control of  tungiasis.</p>\n<p>\n Study Clinician- Askah Moraa, Clinical Officer-10 years experience as CO for Ministry of Health, based at Gede Health Centre. Currently studying for MPH.</p>\n<p>\n Study Community Coordinator-Sammy Baya, Community Health Volunteer, Chairman of CBO and Community Unit coordinator for 6 years, 3 years experience in control of  tungiasis</p>\n<p>\n 30 Community Health Volunteers-trained by MOH and APHIAplus for health promotion activities. 3 years experience in control of  tungiasis.</p>\n<p>\n Dabaso Tujengane CBO has an office with computers, internet access, electricity and water. No laboratory facilities are required for this study</p>\n<p>\n Emergency facilities-patients will be taken to Gede Health Center or Malindi sub-county hospital should the need arise. These are 10  and 30 minutes from the study site respectively. </p>\n
      • other_details_explanation<p>\n Kenya is the host country of the sponsor and and study will be implemented in Kenya. The investigational product is produced in Kenya. The study was conceived and designed by the investigators in Kenya, who sought and obtained funding from German Doctors, a charitable organization with the aim to support health care in low-income countries.</p>\n
      • other_details_regulatory_notapproved<p>\n none</p>\n
      • other_details_regulatory_approved<p>\n KEMRI-SERU, approval date 1st April 2016 (Non-SSC protocol n0. 514). One site in Kenya only.</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 weeks
      • 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_comparatorNational standard for tre
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyNational standard for treatment, potassium permanganate and vaseline
      • single_site_member_stateYes
      • location_of_areaDabaso Tujengane CBO
      • single_site_physical_addressDabaso Trading Centre, Dabaso sub-location, Kilifi North
      • single_site_contact_personDr Lynne Elson
      • single_site_telephone254 729 338457
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteup to 50
      • total_participants_worldwideup to 50
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameUlrike
      • investigator1_middle_name
      • investigator1_family_nameFillinger
      • investigator1_qualificationMSc, PhD
      • investigator1_professional_addressPublic Health Entomologist, Senior Scientist, icipe- Human Health Division, Thomas Odhiambo Campus, Mbita
      • investigator1_telephone00254-721-841452
      • investigator1_emailufillinger@icipe.org
      • organisations_transferred_Yes
      • number_participantsUp to 50
      • notification
      • approval_date28-03-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-06-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n Tungiasis is a neglected tropical skin disease caused by the female sand flea (Tunga penetrans), which burrow into the skin causing immense pain, itching and debilitation as they grow. There is currently no simple, effective, safe and affordable treatment available in endemic countries.</p>\n<p>\n The aim of this study was to determine the efficacy of a traditionally used mixture of neem and coconut oil for topical treatment of tungiasis in coastal Kenya.</p>\n<p>\n Ninety-six school children aged 6-14 years with at least one embedded flea showing two signs of viability, were randomized to be treated with either a blend of 20% virgin neem (Azadirachta indica) seed oil in virgin coconut (Cocos nucifera) oil, or with the current treatment standard of a 0.05% potassium permanganate (KMnO4) foot bath. Up to two viable fleas were selected for each participant and monitored every other day for 7 days after treatment using a digital microscope for signs of viability and abnormal development. Acute pathology was assessed on all areas of the feet. The children reported their level of pain and itching.</p>\n<p>\n While the study product did not kill more fleas than the KMnO4, only 18% of the surviving fleas had two signs of viability on Day 7 in the study product group, compared to 41% in the KMnO4 group (OR 0.32, 95% CI=0.10-0.97, p=0.045), and a significantly higher proportion of fleas were rapidly aged by day 7 (OR 3.4, 95% CI: 1.22-9.49, p=0.019). The neem and coconut oil also reduced acute pathology (p<0.005), and there was a higher probability of children reporting no pain or itching (pain OR 2.2, p=0.05, itching OR2.15, p=0.007). There was a significantly higher probability that children reported increased pain and itching on Day 7 with the standard KMnO4 foot bath treatment (OR 3.6 more pain and OR 2.6 more itching). There were no adverse events associated with the study product or the control product, KMnO4.</p>\n<p>\n The current study had several limitations. Only a single dose of the investigational product and only a single treatment regimen, with treatments on day 1 and day 3, were tested. A higher concentration of the neem oil (i.e. 30:70% v/v) and/or one more application would have likely improved the efficacy of the product within the observation period. Another one or two follow up visits would have been desirable and potentially might have confirmed already a higher efficacy of NC as proposed previously based on data collected by community health volunteers in coastal Kenya and as indicated by the results about rapid aging of embedded fleas in the study product.</p>\n<p>\n In conclusion, both, the neem: coconut oil 20 : 80% (v/v) formulation and the potassium permanganate foot bath standard treatment for tungiasis tested in this trial, were moderately effective, killing on average 30-40% of the embedded sand fleas six days after the initial treatment.  This efficacy matches the findings of a previous clinical trial testing KMnO4. However, whilst the test formulation did, not perform any better than the KMnO4 in terms of killing the fleas during the observation period, several observations indicate that the herbal remedy holds promise for effective and efficient treatment of tungiasis and warrants further studies.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-04-08 16:18:01
      • created2016-04-30 08:53:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id326
        • application_id492
        • given_nameUlrike
        • middle_name
        • family_nameFillinger
        • qualificationMSc, PhD
        • professional_addressPublic Health Entomologist, Senior Scientist, icipe- Human Health Division, Thomas Odhiambo Campus, Mbita
        • telephone00254-721-841452
        • emailufillinger@icipe.org
        • created2016-04-30 08:58:15
        • modified2016-05-30 10:07:21
    • SiteDetail(array)
      • 0(array)
        • id389
        • application_id492
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-04-30 08:58:15
        • modified2016-05-30 10:07:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id258
        • application_id492
        • sponsorInternational Centre of Insect Physiology and Ecology (icipe)
        • sponsor_type(null)
        • contact_personDr Dan Masiga, Head Human and Animal Health Division
        • addressDuduville Campus, Off Thika Road, Kasarani PO Box 30772-00100, Nairobi, Kenya
        • telephone_number+254 20 8632000
        • fax_number
        • cell_number0722207080
        • email_addressdmasiga@icipe.org
        • created2016-04-30 08:58:15
        • modified2016-05-30 10:07:21
  • 3(array)
    • Application(array)
      • id488
      • user_id480
      • trial_status_id5
      • abstract_of_study<div>\n VRC01: human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB in formulation buffer at pH 5.8 in sufficient normal saline (Sodium Chloride for Injection 0.9%, USP) to be administered at a final volume of 150 mL intravenously (IV)</div>\n<div>\n o Control for VRC01: Sodium Chloride for Injection 0.9%, USP administered at a volume of 150 mL IV</div>\n<div>\n o VRC01 or control will be infused every 8 weeks for a total of 10 infusions</div>\n<div>\n o The study products are being provided by the Dale and Betty Bumpers Vaccine Research Center (VRC), NIAID, NIH, DHHS (Bethesda, Maryland, USA)</div>\n
      • study_title<div>\n HVTN 703/HPTN 081</div>\n<div>\n A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection</div>\n
      • laymans_summary<p>\n The AMP Study (also known as HVTN 703/HPTN 081) tests an experimental antibody against HIV. AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies that fight HIV to see if they will protect people from becoming HIV infected. The AMP study tests an antibody called VRC01, a manufactured antibody against HIV. This is a new idea for HIV prevention that is related to what has been done in HIV vaccine research. In traditional HIV vaccine studies, people get a vaccine and researchers wait to see if their bodies will make antibodies against HIV in response to the vaccine. In this study, we will skip that step, and give people the antibodies directly.</p>\n<p>\n The study will enroll and follow about 1,900 adult women in sub-Saharan Africa who are at risk of HIV-1 infection. To join this study, a woman must be a healthy adult and not infected with HIV. She cannot be pregnant or breastfeeding.</p>\n
      • short_titleHVTN 703/HPTN 081 Protocol A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection
      • protocol_noECCT/16/04/01
      • version_noVersion 1.0
      • date_of_protocol11-08-2015
      • study_drugVRCO1
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVRCO1
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameThe comparitor is a placebo
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget0
      • applicant_indemnity_pi0
      • 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_applicantElizabeth A. Ayuo - Kisumu CRS, CRC JOOTRH hospital grounds
      • declaration_date108-04-2016
      • declaration_principal_investigatorDr. Victor Akelo MD
      • declaration_date208-04-2016
      • placebo_presentYes
      • study_objectives<p>\n Primary objective 1: To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in sub-Saharan African women Primary objective 2: To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in sub-Saharan African women</p>\n<p>\n  </p>\n<p>\n Secondary objective 1: To develop a marker(s) of the VRC01 mAb that correlates with the level and antigenic specificity of protection against HIV-1 infection and to provide insight into the mechanistic correlates of protection</p>\n<p>\n  </p>\n<p>\n Exploratory objective 1: To assess use of FTC/TDF in the study cohort</p>\n<p>\n Exploratory objective 2: To assess if prevention efficacy is modified by FTC/TDF use</p>\n<p>\n Exploratory objective 3: To understand changes in risk behavior and the potential for risk compensation for all study participants</p>\n<p>\n Exploratory objective 4: To measure anti-idiotype antibodies to VRC01</p>\n
      • principal_inclusion_criteria<div>\n 1. Age of 18 to 50 years</div>\n<div>\n 2. Access to a participating CRS and willingness to be followed for the planned duration of the study</div>\n<div>\n 3. Ability and willingness to provide informed consent</div>\n<div>\n 4. Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly</div>\n<div>\n 5. Agrees not to enroll in another study of an investigational research agent for the duration of the participant’s trial participation</div>\n<div>\n 6. Good general health as shown by medical history, physical exam, and screening laboratory tests</div>\n<div>\n HIV-Related Criteria:</div>\n<div>\n 7. Willingness to receive HIV test results</div>\n<div>\n 8. Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling</div>\n
      • principal_exclusion_criteria<div>\n Investigational research agents received within 30 days before first infusion</div>\n<div>\n 2. Body mass index (BMI) ≥ 40</div>\n<div>\n 3. Pregnant or breastfeeding</div>\n<div>\n 4. Any reactive, indeterminate, or positive HIV test, even if subsequent testing indicates that the individual is not HIV infected.</div>\n<div>\n Monoclonal antibodies and vaccines</div>\n<div>\n 5. Previous receipt of humanized or human mAbs, whether licensed or investigational</div>\n<div>\n 6. HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 703/HPTN 081 PSRT will determine eligibility on a case-by-case basis.</div>\n<div>\n Immune System</div>\n<div>\n 7. Serious adverse reactions to VRC01 formulation components such as sodium citrate, sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.</div>\n<div>\n 8. Autoimmune disease, including Type I diabetes mellitus (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require consistent immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and AE assessments)</div>\n
      • primary_end_points<div>\n Primary objectives and endpoints</div>\n<div>\n Primary objective 1:</div>\n<div>\n To evaluate the safety and tolerability of VRC01 mAb administered through IV infusion in each of 2 cohorts</div>\n<div>\n Primary endpoint 1:</div>\n<div>\n Local and systemic reactogenicity signs and symptoms, laboratory measures of safety, AEs, SAEs, and rates of discontinuation</div>\n<div>\n Primary objective 2:</div>\n<div>\n To determine if the VRC01 mAb prevents HIV-1 infection and to estimate the level of efficacy in each of 2 cohorts</div>\n<div>\n Primary endpoint 2:</div>\n<div>\n Documented HIV-1 infection by the Week 80 study visit</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 2b. Safety and Efficasy
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Dr. Victor Akelo</div>\n<div>\n MBChB, MPH, MBA</div>\n<div>\n <div>\n Dr. Victor Mudhune</div>\n <div>\n BPharm, MBA, MPH</div>\n</div>\n<div>\n <div>\n Dr Dismas Oketch</div>\n <div>\n MBChB, MSc</div>\n</div>\n<div>\n <div>\n Dr Elisha Okeyo</div>\n <div>\n MD, MPH (c)</div>\n</div>\n<div>\n Arthur Ogendo, MPH</div>\n<div>\n Kevin Cain, MD</div>\n<div>\n David Schnabel, PhD</div>\n<div>\n  </div>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n there are fully equiped clinic rooms that are within clinic block within the CRC (clinical research centre) , well equiped infusion rooms and emergency room adjacent.</p>\n
      • other_details_explanation<p>\n the host country is involved.</p>\n
      • other_details_regulatory_notapproved<p>\n CDC IRB - 1st April 2016</p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU - 3rd March 2016</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorplacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKISUMU CRS
      • single_site_physical_addressAlong kisumu kakamega RD. within Jaramogi Oginga Odinga teaching and referal Hospital
      • single_site_contact_personDr. Victor Akelo
      • single_site_telephone+254721553064
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states29 sites in total
      • number_of_sites
      • multi_country_listUSA, KENYA, SOUTH AFRICA, zimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_site100 participants
      • total_participants_worldwide1500
      • 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_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. Victor Akelo
      • investigator1_middle_name
      • investigator1_family_nameAkelo
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressKisumu CRS - Box 1578 - Kisumu 40100
      • investigator1_telephone+254721553064
      • investigator1_emailvakelo@kemricdc.org
      • organisations_transferred_No
      • number_participants90 participants
      • notification<p>\n Drs Kevin P. Cain and David schnabel will not have direct contact with study participants, their roles in the study will be on implementation and overseeing the smooth running of the study. They do not have practising licence for Kenya neither are they covered on indemnities.</p>\n
      • approval_date14-07-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted06-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results
      • quantity_imported1524
      • quantity_dispensed1291
      • quantity_destroyed233
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2022-11-02 08:02:52
      • created2016-04-07 12:23:56
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id324
        • application_id488
        • given_nameDr. Victor Akelo
        • middle_name
        • family_nameAkelo
        • qualificationMD, MPH
        • professional_addressKisumu CRS, box 1578 - Kisumu 40100
        • telephone+254721553064
        • emailvakelo@kemricdc.org
        • created2016-04-07 12:41:08
        • modified2020-08-06 15:05:40
    • SiteDetail(array)
      • 0(array)
        • id387
        • application_id488
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-04-07 12:41:08
        • modified2020-08-06 15:05:40
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id256
        • application_id488
        • sponsorDivision of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Department of Health and Human Services (DHHS) Bethesda, Maryland, USA
        • sponsor_typeOthers
        • contact_personLawrence Corey
        • addressHVTN; FHCRC 206-667-6770 lcorey@fhcrc.org
        • telephone_number206-667-6770
        • fax_number
        • cell_number206-667-6770
        • email_addresslcorey@fhcrc.org
        • created2016-04-07 12:41:08
        • modified2020-08-06 15:05:40
  • 4(array)
    • Application(array)
      • id481
      • user_id229
      • trial_status_id5
      • abstract_of_study<p>\n Shigellosis remains a major health problem in developing countries with approximately 100 million cases per year mostly in children ≤5 years. Antibiotic resistance of Shigella is increasing and no vaccine is currently available against shigellosis.</p>\n<p>\n The purpose of H03_04TP study is to evaluate the safety and the immunogenicity of two different doses (25 μg and 100 μg) of the GVGH S. sonnei 1790GAHB vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.</p>\n
      • study_title<p>\n A Phase 2a, observer blind, randomized, controlled, Single Center Study to evaluate the Safety, Reactogenicity and Immunogenicity of 2 doses of the GVGH 1790GAHB Vaccine against <em>Shigella sonnei</em>, administered intramuscularly in Adult Subjects from a country endemic for shigellosis [GVGH study H03_04TP]</p>\n
      • laymans_summary(null)
      • short_titleA study of the safety and immune response of 2 doses of a new Shigella vaccine in Kenyan adults.
      • protocol_noECCT/16/02/06
      • version_no2.0
      • date_of_protocol04-11-2015
      • study_drugShigella sonnei 1790GAHB vaccine
      • disease_conditionShigellosis
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • 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_addressgodfrey.m.nyakaya@gsk.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantFrancis Karanja
      • declaration_date115-02-2016
      • declaration_principal_investigatorFrancis Karanja
      • declaration_date215-02-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1) Individuals ≥18 years to ≤45 years of age on the day of informed consent who are resident in the study area and are not planning to leave during the study period.</p>\n<p>\n 2) Individuals who, after the nature of the study has been explained, have voluntarily given written consent according to local regulatory requirements, prior to study entry.</p>\n<p>\n 3) Individuals who can comply with study procedures including follow-up.</p>\n<p>\n 4) Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal function, and liver function tests, urine dipstick/urinalysis and the clinical judgment of the investigator.</p>\n<p>\n 5) Males</p>\n<p>\n Or</p>\n<p>\n Females of childbearing potential who are using an effective birth control method which they intend to use for the duration of the study</p>\n<p>\n Or</p>\n<p>\n Females without childbearing potential (i.e. irrespective of birth control method).</p>\n
      • principal_exclusion_criteria<p>\n 1) Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.</p>\n<p>\n 2) Individuals with any progressive or severe neurological disorder, seizure disorder or previous Guillain-Barré syndrome.</p>\n<p>\n 3) Individuals who, in the judgment of the investigator, may not be able to comply with all the required study procedures.</p>\n<p>\n 4) Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.</p>\n<p>\n 5) Individuals with history of reactive arthritis.</p>\n<p>\n 6) Individuals with known HIV or hepatitis B virus infection or HIV related disease, history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. Individuals under systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to screening.</p>\n<p>\n 7) Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.</p>\n<p>\n 8) Individuals with a neutrophil count lower than 1.8 x 109/L (applicable to the initial 18 subjects) or lower than 1.0 x 109/L (applicable to the additional subjects if approved by DSMB) at screening.</p>\n<p>\n 9) Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, Type 2 diabetes mellitus, hypertension, cardiac, renal or hepatic disease and tuberculosis).</p>\n<p>\n 10) Individuals who have any malignancy or lymphoproliferative disorder.</p>\n<p>\n 11) Individuals with history of allergy to vaccines components or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial.</p>\n<p>\n 12) Individuals participating in any clinical trial with another investigational product within 28 days prior to the screening study visit or intent to participate in another clinical study at any time during the conduct of this study.</p>\n<p>\n 13) Individuals who received vaccines containing meningococcal A, C, W, Y or tetanus, diphtheria or pertussis antigens within 12 months before screening, or any other vaccines within 4 weeks prior to screening in this study or who are planning to receive any vaccine within the entire study duration.</p>\n<p>\n 14) Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the 12 weeks prior to the first dose of the study vaccine.</p>\n<p>\n 15) Individuals who are study personnel or immediate family members (parents, children, spouse and brothers/sisters) to the personnel conducting this study.</p>\n<p>\n 16) Individuals with body temperature > 38.0â—¦C within 3 days of intended study vaccination is a reason for delay of vaccination.</p>\n<p>\n 17) Individuals with Body Mass Index (BMI)> 30 kg/m2</p>\n<p>\n 18) Individuals with history of substance or alcohol abuse within the past 2 years.</p>\n<p>\n 19) Women who are pregnant or are breast-feeding, or are of childbearing age who have not used (for the two months preceding the 1st vaccination) and are not willing to use acceptable contraceptive measures, for the duration of the study. If subjects are women of childbearing potential, they must have a negative pregnancy test at screening visit and prior to enrollment (visit 1). For the purposes of this study acceptable methods of contraception are oral, injected or implantable contraceptives.</p>\n<p>\n 20) Individuals who have a previously laboratory confirmed case of disease caused by S. sonnei.</p>\n<p>\n 21) Any condition which, in the opinion of the investigator, may pose an increased and unreasonable safety risk to the subject if they participated in the study.</p>\n
      • primary_end_points<p>\n <strong>1) Primary Safety Endpoint(s) </strong></p>\n<p>\n The safety profile of the two vaccine doses and control(s) will be assessed through measurement of the following:</p>\n<p>\n a. Number and percentage of subjects with solicited local and systemic adverse reactions during 7 days following each vaccination.</p>\n<p>\n b. Numbers and percentage of subjects with deviations from normal ranges of safety laboratory data after each vaccination.</p>\n<p>\n c. Number and percentage of subjects with reported unsolicited adverse events during 28 days following each vaccination.</p>\n<p>\n d. Number and percentage of subjects with reported SAEs throughout the study duration.</p>\n<p>\n e. Number and percentage of subjects with reported reactive arthritis (AESIs).</p>\n<p>\n <strong>2) Primary Efficacy Endpoint(s) </strong></p>\n<p>\n The study does not have primary efficacy endpoint(s).</p>\n<p>\n <strong>3) Primary Immunogenicity Endpoint(s) </strong></p>\n<p>\n The study does not have primary immunogenicity endpoint(s).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
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      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • 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 Number of staff, names, qualifications, experience -- including study co-ordinators, site facilities, emergency facilities, other relevant infrastructure)</p>\n<p>\n <strong>Number of staff:</strong></p>\n<p>\n The KEMRI Wellcome Trust Research Programme in Kilifi currently has 650 staff including 27 clinical officers, 23 nurses, 1 pharmacist, 4 counselors, and 102 field workers.</p>\n<p>\n <strong>Name</strong>s: ï‚·</p>\n<ul>\n <li>\n Prof. Philip Bejon: KEMRI Wellcome Trust Research Programme Executive Director (and co-PI for study H03_04TP) ï‚·</li>\n <li>\n Dr. Christina Obiero: Principal Investigator (PI) of study H03_04TP ï‚·</li>\n <li>\n Dr. Patricia Njuguna: co-PI for study H03_04TP</li>\n</ul>\n<p>\n <strong>Qualifications/experience </strong></p>\n<p>\n The site staff has previous experience in conducting clinical research on: ï‚·</p>\n<p>\n Infectious Disease (malaria, HIV, pneumococcal infection, Ebola) ï‚·</p>\n<p>\n Vaccines (malaria, Ebola) ï‚·</p>\n<p>\n General fields: behavioral, malnutrition, anemia</p>\n<p>\n A GCP training (done by a member of the monitoring team) is organized every two years and a refresh training is performed in between. The investigators also perform an on-line training on the ethical aspects of clinical trials.</p>\n<p>\n <strong>Site facilities, emergency facilities, other relevant infrastructure: </strong></p>\n<p>\n The clinical site is located within the Kilifi campus in a wide area, close to the Kilifi County Hospital. It is secured with a perimeter wall and 24-hour security. The Kilifi County Hospital (adjacent to KEMRI-WT) is the main government health facility serving residents of Kilifi County and includes a HIV clinic and care service (CCRC) in which the clinical site cooperates in providing care (including patients and people who take part in clinical research). In case of SAE (e.g. in case the study participant needs to be hospitalized), study subjects are referred to this hospital. If the condition becomes worse the subject is transported to the hospital of Mombasa (ambulance is available).</p>\n<p>\n The pharmacy is located within the hospital and provides dedicated staff and service for clinical trials.</p>\n<p>\n The clinical site can count on a number of laboratories that perform both research activities (microbiology, blood cultures, immunology, entomology, cellular immunology, blood culture, DNA sequencing, etc.) and laboratory services for the Kilifi County Hospital. The access to the labs is secured with the use of badges. The labs have a quality assurance system in place and GCLP accreditation. The site can also refer to a dedicated Clinical Trial Laboratory (the safety lab) for hematology, biochemistry, microbiology testing, parasitology, part of microbiology testing, urinalysis and malaria.</p>\n<p>\n The clinical site has an on-site archive dedicated to clinical trials. The site usually refers to an off-site company (G4S) for long-term storage.</p>\n<p>\n In addition to the clinical trials facility, the KEMRI Wellcome Trust Research Programme includes an Epidemiology and Demography department, a Socio-behavioral department, a Data Management department and a Training facility and it is also involved in an ongoing Vaccine Monitoring Surveillance.</p>\n
      • other_details_explanation<p>\n The GSK Vaccines Institute for Global Health develops vaccines against neglected diseases for impoverished communities. Shigellosis remains a major public health problem around the world. It is one of the leading causes of diarrheal disease in low and middle income countries with the majority of these cases occuring in children less than 5 years of age. The Global Enteric Multicenter Study (GEMS) was aimed to evaluate the incidence of moderate & severe diarrhea (MSD) in children aged less than 5 years of age in sub-Saharan Africa and South Asia, with study sites in Gambia, Kenya, Mali, Mozambique, India, Bangladesh, and Pakistan. The results of this study have consistently indicated that shigellosis is one of the top 5 causes of MSD in each of the three age sub groups being considered: 0-11 months, 12-23 months and 24-59 months, respectively.</p>\n<p>\n The Shigella sonnei vaccine has been developed by GVGH and the first-in-human clinical Phase 1 studies have been performed in Europe at two trial sides, one in France (dose escalation up to 100 μg of protein) and one in the UK (different routes of administration). The clinical Phase 2a study is designed to evaluate the safety profile of two injections of S. sonnei 1790GAHB vaccine in healthy adults in Kenya, a Shigella endemic country.</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable.</p>\n
      • other_details_regulatory_approved<p>\n Not applicable.</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration5 months (anticipated start date: 2016-03-01; anticipated end date: 2016-07-30)
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyObserver blind
      • design_controlled_comparatorMenveo and Boostrix
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyGAHB-Placebo is used to dilute 1790GAHB vaccine at clinical site to prepare 25 μg dose (as protein) in support of dose response evaluation.
      • single_site_member_stateYes
      • location_of_areaKenya Medical Research Institute (KEMRI) -Wellcome Trust Research Programme
      • single_site_physical_addressP.O.Box 230 - 80108, Kilifi, Kenya
      • single_site_contact_personDr Christina Obiero
      • single_site_telephone(+254) 417 522535/522063/525043
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site72
      • total_participants_worldwide72
      • 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_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_nameChristina
      • investigator1_middle_nameWesonga
      • investigator1_family_nameObiero
      • investigator1_qualificationBachelor of Medicine and Bachelor of Surgery (MBChB); Master of Public Health (MPH)
      • investigator1_professional_addressKenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, P.O.Box 230, 801080 Kilifi, Kenya
      • investigator1_telephone+254 721889581
      • investigator1_emailcobiero@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participants72
      • notification
      • approval_date15-04-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-02-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonYour study is now approved
      • final_reportDISCUSSION AND OVERALL CONCLUSIONS\nThe present report evaluated the safety and immunogenicity profile of 2 different doses of 1790GAHB vaccine in healthy adults at 28 days after first and second vaccination by measuring the anti-S sonnei LPS serum IgG.\nThe immunogenicity results show a baseline antibody concentration much higher than previously observed in European subjects. This is likely due to a persistent natural exposure to S sonnei in endemic countries. Overall, across all the vaccine groups, a very good immunogenicity response was observed after each vaccination, despite high baseline concentrations. Immunogenicity after the first vaccination was higher in the 5.9/100MCG_SHI group, reached plateau and did not show any significant variation after the second vaccination. By contrast, after the second vaccination, a further increase in antibody concentration was recorded in the 1.5/25MCG_SHI group. As expected, no change in antibody levels was observed in the control group. All the investigational vaccine groups achieved high seroresponses rates and all subjects in these groups achieved anti-S sonnei LPS IgG ≥121 EU/mL.\nAll vaccines were well tolerated. The most commonly reported local AE was injection site pain. Most of the solicited AEs were mild to moderate in severity and limited in duration. The most commonly reported systemic AE was headache, followed by arthralgia, chills, fatigue, malaise and myalgia.\n\nDuring the trial, 10 episodes of neutropenia fulfilling the protocol definition of AESI\nwere reported in 2 (9%), 3 (12%) and 1 (4%) participants in the 1.5/25 μg, 5.9/100 μg,\nand control groups, respectively. These episodes were all considered probably or possibly related to vaccination; 2 of them occurred in the 1.5/25 μg group (1 mild and 1 moderate),5 in the 5.9/100 μg group (4 mild and 1 moderate) and 3 in the control group (1 mild, 1 moderate and 1 severe). Two subjects in the 5.9/100 μg group were withdrawn from 2nd\nvaccination due to neutropenia; a 3rd should have been withdrawn but inadvertently was\nnot and experienced moderate neutropenia at day 57. All cases were transient (recovering\nwithin 7 days and recovered at study end) and, except for one subject in the 5.9/100 μg\ngroup who experienced upper respiratory tract infection (D1) and 38.1°C fever (D8), were\nalso asymptomatic, as confirmed by daily home visits during the 7 days post\nvaccination. Eight of these episodes occurred in 5 of the 18 individuals from the first\ncohort (screened and monitored using the ANC Western threshold of 1.8*109/L), While\nthe remaining 2 episodes occurred in one of the 54 participants in the second cohort\n(screened and monitored using the local threshold of 1.0*109/L). No SAEs occurred in the\nstudy. However, as defined in the study protocol the AESIs were reported as SAEs. There\nwas no case of reactive arthritis recorded.\n
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      • final_date(null)
      • modified2019-07-19 10:25:13
      • created2016-02-14 22:12:10
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id321
        • application_id481
        • given_nameChristina
        • middle_nameWesonga
        • family_nameObiero
        • qualificationBachelor of Medicine and Bachelor of Surgery (MBChB); Master of Public Health (MPH)
        • professional_addressKenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme, P.O.Box 230, 801080 Kilifi, Kenya
        • telephone+254 721889581
        • emailcobiero@kemri-wellcome.org
        • created2016-02-14 22:57:03
        • modified2016-02-15 18:49:17
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        • id382
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        • county_id(null)
        • site_name
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        • contact_details
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        • misc(null)
        • created2016-02-14 22:57:03
        • modified2016-02-15 18:49:17
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        • id254
        • application_id481
        • sponsorGSK Vaccines Institute for Global Health (GVGH)
        • sponsor_type(null)
        • contact_personAudino Podda
        • addressVia Fiorentina, 53100 Siena, Italy
        • telephone_number0039 0577 24 3496
        • fax_number0039 0577 24 9114
        • cell_number0039 335 7026 950
        • email_addressaudino.p.podda@gsk.com
        • created2016-02-14 22:57:03
        • modified2016-02-15 18:49:17
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