Clinical Trials authorized in Uganda from April 2016 – 8th August 2018

 SNCTA #TitleDate of initial authorization/rejectionPrincipal InvestigatorInstitutionStatus
1.       1“Malaria Chemoprevention with monthly treatment with dihydroartemisinin-piperaquine for the post-discharge management of severe anemia in children aged less than 5 years in Uganda and Kenya: A 3-year, multi-center, parallel-group, two arm randomized placebo controlled superiority trial” Version 2 dated 12th November 2015 04/04/2016Dr. Robert Opika OpokaDepartment of Pediatrics and Child Health, MUCHS Ongoing
2.       2“Doxycycline for the treatment of nodding syndrome: A phase II, randomized placebo controlled trial” Version 1.1 dated 19th January 201605/04/2016Dr. Richard IdroDepartment of Pediatrics and Child Health, MUCHSOngoing
3.       3“Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability, and Anti-Retroviral Activity of GSK 1349572 (Dolutegravir), a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents (IMPAACT P1093)” Version 3.0 Dated 16th January 201319/05/2016Dr. Linda Barlow MoshaMU-JHU Research CollaborationOngoing
4.       4“Prevention of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 3)” Version 1.0 dated 20th January 201609/08/2016Prof. Moses KamyaMU-UCSFOngoing
5.       5“A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS -9883/ Emtricitabine/Tenofovir Alafenamide (GS - 9883/F/TAF) from Elvitegravir /Cobicistat /Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF), or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumerate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women.” Version 2 dated 21st January 201411/05/2016Dr. Cissy Kityo MutuluzaJoint Clinical Research CentreOngoing
6.       6“A randomized trial of dolutegravir (DTG)-based antiretroviral therapy vs standard of care (SOC) in children with HIV infection starting first line or switching to second line ART (ODYSSEY PENTA 20)” Version 2.0 dated 6th March 2015.15/07/2016Dr. Cissy Kityo MutuluzaJoint Clinical Research CentreOngoing
7.       7“Pharmacokinetics of efavirenz 400 mg once daily during pregnancy in HIV -1 infected women.”07/07/2016Dr. Mohammed LamordeInfectious Diseases InstituteClosed out
8.       8“Investigation of rheumatic AF Treatment Using Vitamin K antagonists, rivaroxaban or aspirin Studies. (INVICTUS)” 12/12/2016Dr. Emmy OkelloUganda Heart InstituteOngoing
9.       9“A Multi-center, Phase 3B Open-label Follow-up trial to assess the continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women (MTN 025).” Version 2.0 dated 16th December 201405/09/2016Dr. Brenda Gati MirembeMU-JHU Research CollaborationOngoing
10.   10“A Multi-country, prospective, clinical safety study of subjects exposed to the candidate Ebola vaccines Ad26.ZEBOV and/or MVA –BN-Filo” Version 2.0 dated 25th November 2015 02/09/2016Prof. Pontiano KaleebuMRC/UVRIOngoing
11.   11“A Pharmacokinetic Evaluation of Increased Dose Levonorgestrel Implant and Efavirenz-Based Antiretroviral Therapy In HIV-Infected Women”10/03/2017Dr. Mohammed LamordeInfectious Diseases InstituteOngoing
12.   12“A multicenter, open label , randomized , multiple dose , two period crossover, bioequivalence study of Liposomal Amphotericin B injection (Cipla Ltd. , India) and AmBisome® Liposome for injection (Gilead life sciences, USA ) in adult patients with fungal infections” 01/11/2016Dr. Henry MugerwaJoint Clinical Research CentreOngoing
13.   13“A Follow-Up Open Label Trial to Assess The Continued Safety of and Adherence to the Dapivirine (25mg) Vaginal Ring-004 in Healthy HIV-Negative Women (Phase IIIb)”10/10/2016Dr. Sylvia KusemererwaMRC/UVRIOngoing
14.   14“Strategy for Maintenance of HIV Suppression with Elvitegravir + Darunavir +Ritonavir in Children (SMILE PROTOCOL)”06/02/2017Dr. Victor MusiimeJoint Clinical Research CentreAmended to CTA 0065
15.   15“Defining the Molecular profile of Breast Cancer in Uganda and its Clinical Implications”02/03/2017Dr. Jackson OremUganda Cancer InstituteOngoing
16.   16“Optimizing Hydroxyurea Therapy in Children with Sickle Cell Anemia in Malaria Endemic Areas : The NOHARM Maximum Tolerated Dose (MTD) Extension Study” Version 1.0 dated 16th September 201628/03/2017Dr. Robert Opika OpokaDepartment of Pediatrics and Child Health, MUCHS Ongoing
17.   17“The effect of modified F-75 on diarrhea in the treatment of children with severe acute malnutrition.”31/01/2017Dr. Elizabeth KibonekaMwana Mugimu Nutrition Unit, MulagoTerminated
18.   18A Phase 2/3 , Open Label Study of the Pharmacokinetics , Safety, and Antiviral Activity of the GS-9883/ Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) in HIV-1 infected Virologically Suppressed Adolescents and Children17/03/2017Dr. Eva NatukundaJoint Clinical Research CentreOngoing
19.   19“Anti-retroviral therapy for acute HIV infection” Version 1.5 dated 16th August 201715/02/2018Dr. Francis KiweewaMakerere University Walter Reed Project.Ongoing
20.   21“An open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccines from EV06 trial” Version 1.0 dated 6th October 201610/03/2017Prof. Pontiano KaleebuMRC/UVRIClosed Out
21.   22“Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans (CREOLE)” Version 1.9 dated July 201631/05/2017Dr. Mondo Charles KiizaSt. Francis Hospital NsambyaOngoing
22.   23“Phase 1 Safety and Pharmacokinetic Study of Maraviroc in HIV-1- Exposed Infants at Risk of Acquiring HIV-I Infection” Version 1.0 dated 13th April 201614/06/2017Dr. Jesca NakibuukaMU-JHU Research CollaborationOngoing
23.   24“Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial”26/04/2017Prof. Peter MugyenyiJoint Clinical Research CentreOngoing
24.   25“An international multi-center controlled clinical trial to evaluate 1200mg and 1800mg rifampicin daily in the reduction of treatment duration for pulmonary tuberculosis from 6 months to 4 months (Rifashort)”14/06/2017Dr. Daniel AtwineEpicentre - Mbarara Research BaseOngoing
25. 26“Hormonal Contraception and Bacterial Vaginosis (HCBV): The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis among Women at High Risk for HIV infection in Kampala, Uganda” Version 1.4 dated 30th November 201729/03/2017Prof. Janet SeeleyMRC/UVRIOngoing
26.   27“The evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TB (STREAM)” Version 6.2 dated February 201523/05/2017Dr. Bruce KirengaMakerere University – Lung InstituteOngoing
27.   28“Assessing the tolerability and safety of single low dose Primaquine in African Children with Acute Uncomplicated Falciparum Malaria and Glucose-6-Phoasphate Dehydrogenase Deficiency.” Version 1.0 dated 23rd October 201622/06/2017Dr. Peter Olupot-OlupotMbale Clinical Research InstituteOngoing
28.   29“First line Antimicrobials in Children with complicated Severe Acute Malnutrition (FLACSAM)” Version 1.01 dated 12th January 201722/06/2017Dr. Peter Olupot-OlupotMbale Clinical Research InstituteOngoing
29.   30“IMPAACT 2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir Containing versus Efavirenz Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants.” Version 1.0 dated 1st December 201629/09/2017Dr. Deo WabwireMU-JHU Research CollaborationOngoing
30.   31“Randomized clinical trial evaluating sertraline plus fluconazole verses fluconazole alone for pre-emptive treatment of asymptomatic cryptococcal antigenemia in HIV-Infected persons living with AIDS.” Version 1.0 dated 7th February 201711/08/2017Dr. David MeyaInfectious Diseases InstituteOngoing
31.   32“IMPAACT 2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir –Containing and Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1 Infected Pregnant Women and their Infants” Version 1.0 dated 1st December 201620/10/2017Dr. Violet KorutaroBaylor College of Medicine Children’s Foundation UgandaOngoing
32.   33“HPTN084: A Phase 3 Double Blind Safety and Efficacy Study of Long Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV- Uninfected Women.” Version 1.0 dated 2nd March 2017.13/10/2017Dr. Clemensia NakabiitoMU-JHU Research CollaborationOngoing
33.   34“A Randomized, blinded non-inferiority trial on the immunogenicity and safety of fractional doses of yellow fever vaccines (YEFE).” Version 10 dated 24th July 2017.04/10/2017Dr. Patrick KazoobaEpicentre - Mbarara Research BaseOngoing
34.   35“Randomized Trial to Prevent Vascular Events in HIV-REPRIEVE” Protocol No: A5332, Version 3.0 dated 28th January 201627/09/2017Prof. Peter MugyenyiJoint Clinical Research CentreOngoing
35.   36“Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses”. Version 1.0 dated 19th April 201611/12/2017Prof. Peter MugyenyiJoint Clinical Research CentreOngoing
36.   37“A Phase two interventional multi-center randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersible Formulation in the combination given once daily for 1,2 and 3 days to adults and children with uncomplicated Plasmodium Falciparum Malaria.” Version 2 dated 14th February 201709/03/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
37.   38“A Phase two interventional multi-center randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersible Formulation in the combination given once daily for 1,2,and 3 days to adults and children with uncomplicated Plasmodium Falciparum Malaria”10/01/2018Dr. Sylvia KusemererwaMRC/UVRIOngoing
38.   39Optimizing iron status while minimizing morbidity in HIV-Infected Ugandan Children’ version 1.4 dated 23rd May 2017.03/01/2018Dr. Victor MusiimeJoint Clinical Research CentreOngoing
39.   40“An open Label Phase III Randomized Controlled Multicenter Non inferiority Trial to compare Efficacy and Safety of Miltefosine and Paramomycin with Sodium Stigbogluconate and Paramomycin combination for the treatment of Primary Visceral Leishmaniasis (VL) patients in East Africa. Version 2.0 dated 5th September 201522/01/2018Prof. Joseph OloboDepartment of Immunology and Molecular Biology, Makerere UniversityOngoing
40.   41“Testing the ability of a microbiome-focused intervention to reduce HIV susceptibility in Ugandan men” Protocol No: TmHIV-01, Version 1.2 dated April 18th 201717/10/2017Dr. Bernard S. BagayaUVRI-IAVI HIV Vaccine ProgramOngoing
41.   42“Dolutegravir in Pregnant HIV Mother and their Neonates (DOLPHIN-2)”. Protocol version 3.0 dated 19th June 201712/12/2017Dr. Mohammed LamordeInfectious Diseases InstituteOngoing
42.   44“A phase 2a Crossover Trial to Evaluate the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population.” Version 1.0, Dated 2nd February 201709/07/2018Dr. Carolyne Agwau AkelloMU-JHU Research CollaborationOngoing
43.   45“Steady-state pharmacokinetics of Efavirenz (Stocrin) 400 mg once daily in the presence of rifampicin and isoniazid (Rifinah or the local generics)”. Protocol SSAT062, Version 7.0 dated 26th September 2017.03/01/2018Dr. Mohammed LamordeInfectious Diseases InstituteOngoing
44.   46“HIV Self-testing to empower Prevention Choices in Sex workers.” Protocol version 1.6 dated 28th July 201703/01/2018Dr. Andrew MujugiraInfectious Diseases InstituteOngoing
45.   47“A Randomized, Double-Blind, Efficacy and Safety Study of Azilsartan Medoxomil Treatment and Withdrawal, followed by Open-Label Extension, in Children 6 to Less Than 18 Years of Age with Hypertension”. Protocol Version 1.0 dated 20th February 2017.30/04/2018Dr. Henry Mugerwa, Dr. Victor Musiime, Dr. Edson Mworozi, Dr. Charles MondoJoint Clinical Research Center / MUCHS/ St. Francis Hospital NsambyaRejected
46.   49“A phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. (HPTN 084)” Version 1.0 dated 2nd March 2017.04/04/2018Dr. Patricia Nahirya NtegeBaylor College of Medicine Children’s FoundationOngoing
47.   50“A Phase 2, multicenter, randomized open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria”. Protocol Version 1 dated 5th April 2017.06/03/2018Dr. Henry MugerwaJoint Clinical Research CentreOngoing
48.   51“A Phase 2, multicenter, randomized open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria” Version 1 dated 5th April 201728/02/2018Dr. Stephen AsiimweKabwohe Clinical Research CentreOngoing
49.   52“A Phase 2, Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in HIV-1-Infected Adults Failing a Nucleos(t)ide Reverse Transcriptase Inhibitor-Containing Regimen with Nucloes(t)ide Transcriptase Inhibitor Resistant Virus, Followed by Continued Treatment with a GS-9131+Bictegravir+Darunavir+Ritonavir Regimen,” Protocol Number: GS-US-442-4148, Version: Amendment 1 dated 24th August 2017.06/02/2018Dr. Cissy Kityo Mutuluuza,Joint Clinical Research CentreOngoing
50.   53“HIV Self-Testing and PrEP to Increase Testing and Prevention Uptake among Male Partners and improve postpartum ART Use in PMTCT B+ Programs in Uganda” Protocol version 2.0 dated 16th August 201703/01/2018Prof. Elly KatabiraInfectious Diseases InstituteOngoing
51.   54“Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women.” Version 2.1, Dated 12th July 201717/04/2018Prof. Elly KatabiraInfectious Diseases InstituteOngoing
52.   55“A Pharmacokinetic Evaluation of Etonogestrel Implant in HIV-Infected Women on Darunavir Versus Rilpivirine-Based Antiretroviral Therapy (DRIVE-1). Version 2.0, dated 7th August 201726/06/2018Prof. Mohammed LamordeInfectious Diseases InstituteOngoing
53.   56“A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir versus Rilpivirine-based Antiretroviral Therapy (DRIVE-2)”. Version 2.0, 18th August 2017.27/06/2018Prof. Mohammed LamordeInfectious Diseases InstituteOngoing
54.   57“A Phase 2, multicenter, randomized open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria” Version 1 dated 5th April 2017.01/03/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
55.   58“A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV Uninfected Women” Version 1.0 dated 2nd March 201704/04/2018Dr. Juliet MpendoUganda Virus Research Institute-International AIDS Vaccine InitiativeOngoing
56.   60“Integrated PrEP and ART delivered in Ugandan public health clinics to improve HIV and ART outcomes for HIV serodiscordant couples”. Protocol Version 1.0, dated 8th November 201621/06/2018Prof. Elly KatabiraInfectious Diseases InstituteOngoing
57.   61“High-Dose Intravenous Rifampicin to Improve Survival of Tuberculosis Meningitis: A phase II open-label randomized controlled trial (RifT Study).” Protocol Version 1.2.1 dated 19th February 2018.18/06/2018Dr. David B. MeyaInfectious Diseases InstituteOngoing
58.   62“IMPAACT 2009: Pharmacokinetics, Feasibility, Acceptability and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants.” Version 1.0, dated 19th October 2017.22/06/2018Dr. Clemensia NakabiitoMUJHU Research CollaborationOngoing
59.   63“EMaBS TB Vaccine Study: Open label, dose escalation and age de-escalation for ChAdox1 85A in Ugandan adults and adolescents, followed by a Phase IIa randomized, open-label trial among adolescents comparing ChAdOx1 85A prime followed by MVA85A boost versus BCG re-vaccination”. Version 1.2 dated 6th February 201820/07/2018Prof. Alison ElliotMRC/UVRI and LSHTM Uganda Research UnitOngoing
60.   64High Dose AMBISOME on a fluconazole backbone for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: A Phase 3 Randomised Non- Inferiority Trial (AMBITION-CM). Version 1.0 dated 13th February 201822/06/2018Dr. David MeyaInfectious Diseases InstituteOngoing
61.   65“A Phase 2/3 Multi-centre, Open-label, Randomized study evaluating the Safety and Anti-viral effect of once daily integrase inhibitor administered with Darunavir/ritonavir (DRV/r) compared to current Standard of Care (SOC) antiretroviral therapy in HIV-1 infected, virologically suppressed Pediatric participants”. Version 2.0, dated 24th July 201722/06/2018Dr. Victor MusiimeJoint Clinical Research CentreOngoing
62.   67“Efficacy and Safety of Artemether-Lumefantrine, Artesunate-Amodiaquine and Dihydroartemisinin-Piperaquine for The Treatment of Uncomplicated Plasmodium Falciparum Malaria in Uganda.” Protocol version 1.7, dated 4th May 201804/07/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing