Clinical Trials authorized in Uganda since 2016 – Updated on 12th October 2020

 SNCTA #+H9HB2:H10TitleDate of initial AuthorizationPrincipal InvestigatorInstitutionSponsorStatus
1.      0001“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 4/4/2016Dr. Robert Opika OpokaDepartment of Pediatrics and Child Health, MUCHS Liverpool school of Tropical Medicine (LSTM)Closed Out
2.      0002“Doxycycline for the treatment of nodding syndrome: A phase II, randomized placebo controlled trial” Version 1.1 dated 19th January 20165/4/2016Dr. Richard IdroDepartment of Pediatrics and Child Health, MUCHSOngoing
3.      0003“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 201319/5/2016Dr. Linda Barlow MoshaMU-JHU Care Ltd.United States National Institute of HealthOngoing
4.      0004“Prevention of Malaria in HIV-uninfected Pregnant Women and Infants (PROMOTE Birth Cohort 3)” Version 1.0 dated 20th January 20169/8/2016Prof. Moses KamyaMU-UCSFClosed-Out
5.      0005“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 201411/5/2016Dr. Cissy Kityo MutuluzaJoint Clinical Research CentreOngoing
6.      0006“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 2015.15/7/2016Dr. Cissy Kityo MutuluzaJoint Clinical Research CentreOngoing
7.      0007“Pharmacokinetics of efavirenz 400 mg once daily during pregnancy in HIV -1 infected women.”7/7/2016Dr. Mohammed LamordeInfectious Disease InstituteClosed-Out
8.      0008“Investigation of rheumatic AF Treatment Using Vitamin K antagonists, rivaroxaban or aspirin Studies. (INVICTUS)” 12/12/2016Dr. Emmy OkelloUganda Heart InstitutePopulation Health Research InstituteOngoing
9.      0009“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 20145/9/2016Dr. Brenda Gati MirembeMUJHU care Ltd.Division of AIDS(DAIDS), United States (US) National Institute of Allergy and Infectious Disease(NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), US National Institute of Health (NIH)Closed out
10.   0010“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 2/9/2016Prof. Pontiano KaleebuMRC/UVRIJanssen VaccineOngoing
11.   0011“A Pharmacokinetic Evaluation of Increased Dose Levonorgestrel Implant and Efavirenz-Based Antiretroviral Therapy In HIV-Infected Women”10/3/2017Dr. Mohammed LamordeInfectious Diseases InstituteOngoing
12.   0012“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” 1/11/2016Dr. Henry MugerwaJoint Clinical Research CentreClosed out
13.   0013“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.   0014“Strategy for Maintenance of HIV Suppression with Elvitegravir + Darunavir +Ritonavir in Children (SMILE PROTOCOL)”6/2/2017Dr. Victor MusiimeJoint Clinical Research CentrePENTA FoundationAmended to CTA0065
15.   0015“Defining the Molecular profile of Breast Cancer in Uganda and its Clinical Implications”2/3/2017Dr. Jackson OremUganda Cancer InstituteGSKOngoing
16.   0016“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 201628/3/2017Dr. Robert Opika OpokaGlobal Health Uganda / Pediatric Department, Mulago Hospital Doris Duke Chariatable FoundationOngoing
17.   0017“The effect of modified F-75 on diarrhea in the treatment of children with severe acute malnutrition.”31/1/2017Dr. Elizabeth KibonekaMwana Mugimu Nutrition Unit, Mulago HospitalUniversity of CopenhagenTerminated
18.   0018A 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 Children17/3/2017Dr. Eva NatukundaJoint Clinical Research CentreGilead SciencesOngoing
19.   0019“Anti-retroviral therapy for acute HIV infection” Version 1.5 dated 16th August 201715/2/2018Dr. Francis KiweewaMakerere University Walter Reed Project.Henry M Jackson Foundation,United States Military HIV Research ProgramClosed out
20.   0021“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 201610/3/2017Prof. Pontiano KaleebuMRC/UVRIHenry M Jackson Foundation, PEPFARClosed out
21.   0022“Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans (CREOLE)” Version 1.9 dated July 201631/5/2017Dr. Mondo Charles KiizaSt. Francis Hospital NsambyaUniversity of AbujaTBC
22.   0023“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 201614/6/2017Dr. Jesca NakibuukaMU-JHU care Ltd.Division of AIDS(DAIDS), United States (US) National Institute of Allergy and Infectious Disease(NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), US National Institute of Health (NIH)Withdrawn
23.   0024“Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial”26/4/2017Dr. Cissy Kityo MutuluuzaJoint Clinical Research CentreOngoing
24.   0025“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)”14/6/2017Dr. Daniel AtwineEpicentre - Mbarara Research BaseSt George University of LondonOngoing
25. 0026“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 201729/3/2017Prof. Janet SeeleyMRC/UVRILondon School of Hygiene and Tropical MedicineOngoing
26.   0027“The evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TB (STREAM)” Version 6.2 dated February 201523/5/2017Dr. Bruce KirengaMakerere University – Lung InstituteThe International Union Against the TB and Lung Disease (IUATLD)Ongoing
27.   0028“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 201622/6/2017Dr. Peter Olupot-OlupotMbale Clinical Research InstituteMahidol Oxford Research Unit-University of OxfordOngoing
28.   0029“First line Antimicrobials in Children with complicated Severe Acute Malnutrition (FLACSAM)” Version 1.01 dated 12th January 201722/6/2017Dr. Peter Olupot-OlupotMbale Clinical Research InstituteOxford UniversityOngoing
29.   0030“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 201629/9/2017Dr. Deo WabwireMU-JHU care Ltd.Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID)Ongoing
30.   0031“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 201711/8/2017Dr. David MeyaInfectious Diseases InstituteOngoing
31.   0032“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 UgandaDivision of AIDS(DAIDS), United States (US) National Institute of Allergy and Infectious Disease(NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), US National Institute of Health (NIH)Ongoing
32.   0033“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 care Ltd.Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH),Ongoing
33.   0034“A Randomized, blinded non-inferiority trial on the immunogenicity and safety of fractional doses of yellow fever vaccines (YEFE).” Version 10 dated 24th July 2017.4/10/2017Dr. Maria Loiuse NamulwanaEpicentre - Mbarara Research BaseRebecca Grais, Director Research EpicenterOngoing
34.   0035“Randomized Trial to Prevent Vascular Events in HIV-REPRIEVE” Protocol No: A5332, Version 3.0 dated 28th January 201627/9/2017Prof. Cissy Kityo MutuluuzaJoint Clinical Research CentreDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH),Ongoing
35.   0036“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 201611/12/2017Dr Cissy KityoJoint Clinical Research CentreNational Institute of Allergy and Infectious Disease(NIAID)Closed-out
36.   0037“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 20179/3/2018Dr. Adoke YekaInfectious Diseases Research CollaborationNovartis Pharma AGOngoing
37.   0038“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”10/1/2018Dr. Sylvia KusemererwaMRC/UVRINovartis PharmaceuticalsOngoing
38.   0039Optimizing iron status while minimizing morbidity in HIV-Infected Ugandan Children’ version 1.4 dated 23rd May 2017.3/1/2018Dr. Victor MusiimeJoint Clinical Research CentreUniversity of Minnesota Msonic Cross-Departmental Grants for Childrens Health ResearchOngoing
39.   0040“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 UniversityDrugs For Neglected Disease InitiativeOngoing
40.  "0041“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 ProgramCanadia Institute of Health Research (CIHR)Ongoing
41.   0042“Dolutegravir in Pregnant HIV Mother and their Neonates (DOLPHIN-2)”. Protocol version 3.0 dated 19th June 201712/12/2017Dr. Mohammed LamordeInfectious Diseases InstituteUniversity of LiverpoolOngoing
42.   0043“A Pilot Study of Nelfinavir for the Treatment of Kaposi’s Sarcoma (AmC 098).” Version 1.0 dated 16 March 201616/10/2018Dr. Jackson OremUganda Cancer InstituteAIDS Malignancy ConsortiumOngoing
43.   0044“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 20179/7/2018Dr. Carolyne Agwau AkelloMU-JHU Research CollaborationDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Health (NIH)Ongoing
44.   0045“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 2017.3/1/2018Dr. Mohammed LamordeInfectious Diseases InstituteSt Stephens' AIDS Trust, LondonClosed out
45.   0046“HIV Self-testing to empower Prevention Choices in Sex workers.” Protocol version 1.6 dated 28th July 20173/1/2018Dr. Andrew MujugiraInfectious Diseases InstituteForgaty International CenterOngoing
46.   0047“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.N/ADr. Henry MugerwaJoint Clinical Research CenterRejected
47.   0048“Simplified Isoniazid Preventive Therapy (SPIRIT) Strategy to reduce TB burden” Version 1.0 dated 30th March 20178/11/2018Prof Moses KamyaInfectious Disease Research CollaborationNational Institute of Allergy and Infectious Disease(NIAID)Ongoing
48.   0049“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 2017.4/4/2018Dr. Patricia Nahirya NtegeBaylor College of Medicine Children’s FoundationDivision of AIDS(DAIDS), United States (US) National Institute of Allergy and Infectious Disease(NIAID), US National Institute of Health (NIH)Ongoing
49.   0050“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 2017.6/3/2018Dr. Henry MugerwaJoint Clinical Research CentreNovartis Pharma AGClosed out
50.   0051“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 201728/2/2018Dr. Stephen AsiimweKabwohe Clinical Research CentreNovartis Pharma AGClosed Out
51.   0052“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 2017.6/2/2018Dr. Cissy Kityo Mutuluuza,Joint Clinical Research CentreGilead SciencesOngoing
52.   0053“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 20173/1/2018Professor Elly KatabiraInfectious Diseases InstituteUS National Institute of Mental HealthOngoing
53.   0054“Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women.” Version 2.1, Dated 12th July 201717/4/2018Professor Elly KatabiraInfectious Diseases InstituteUniversity of Washington,Ongoing
54.   0055“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 201726/6/2018Prof. Mohammed LamordeInfectious Diseases InstituteInfectious Disease InstituteOngoing
55.   0056“A Pharmacokinetic Evaluation of Levonorgestrel Implant in HIV-Infected Women on Darunavir versus Rilpivirine-based Antiretroviral Therapy (DRIVE-2)”. Version 2.0, 18th August 2017.27/6/2018Prof. Mohammed LamordeInfectious Diseases InstituteInfectious Disease InstituteOngoing
56.   0057“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 2017.1/3/2018Dr. Adoke YekaInfectious Diseases Research CollaborationNovartisClosed Out
57.   0058“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 20174/4/2018Dr. Juliet MpendoUganda Virus Research Institute-International AIDS Vaccine InitiativeDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH)Ongoing
58.   0060“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 201621/6/2018Prof. Elly KatabiraInfectious Diseases InstituteUniversity of WashingtonOngoing
59.   0061“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 2018.18/6/2018Dr. David B. MeyaInfectious Diseases InstituteInfectious Disease InstituteOngoing
60.   0062“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 2017.22/6/2018Dr. Clemensia NakabiitoMUJHU Research CollaborationNational Institute of Allergy and Infectious Disease(NIAID)Ongoing
61.   0063“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 201820/7/2018Prof. Alison ElliotMRC/UVRI and LSHTM Uganda Research UnitUniversity of oxford clinical trials and Research Governance Joint Research OfficeOngoing
62.   0064High 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 201822/6/2018Dr. David MeyaInfectious Diseases InstituteLondon School of Hygiene and Tropical Medicine (LSHTM)Ongoing
63.   0065“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 201722/6/2018Dr. Victor MusiimeJoint Clinical Research CentrePENTA FoundationOngoing
64.   0066“Children with HIV in Africa - Pharmacokinetics and Acceptability of Simple Second-line Anti-Retroviral Regimens.” Version 2.0 dated 8th November 201729/7/2018Dr. Victor MusiimeJoint Clinical Research CenterUniversity College of LondonOngoing
65.   0067“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 20184/7/2018Dr. Adoke YekaInfectious Diseases Research CollaborationNational Malaria Consortium Program, MOH, WHO Country officeOngoing
66.   0068“GwokO Adunu pa Lutino” (GOAL Trial) – Determining the Impact of Penicillin on Latent Rheumatic Heart Disease: A Randomized Controlled Trial” Version 1.0, dated 12th November 201720/8/2018Dr. Emmy OkelloUganda Heart InstituteChildren’s National Medical CentreOngoing
67.   0069“Encochleated Oral Amphotericin for Cryptococcal Meningitis (EnACT)”. Version 0.7.6, dated 1st November 2017.4/10/2018Dr. David B. MeyaInfectious Diseases InstituteMatinaas Biopharma Nanotechnologies, Inc USAOngoing
68.   0070“A Phase 1 Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of an Ebola Sudan Chimpanzee Adenovirus Vector Vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S), in Healthy Adults.” Version 1.2 dated 21 December 201726/11/2018Dr. Betty MwesigwaMakerere University Walter Reed ProjectNational Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH), Vaccine Research Centre (VRC) Bethesda, MarylandOngoing
69.   0071“Zinc for Infection Prevention in Sickle Cell Anaemia (ZIPS)” Version 1.0, dated 19th March 201823/8/2018Dr. Robert OpokaDepartment of Pediatrics and Child Health, MUCHSThrasher Research FundOngoing
70.   0072“An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSV?G-ZEBOV-GP.” Version 1.7, dated 20th June 201721/9/2018Dr. Juliet Mwanga AmumpaireEpicenter Mbarara Research CenterMedicins Sans FrontieresOngoing
71.   0073“A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola vaccines Ad26.ZEBOV and/or MVA-BN-Filo, Phase 3.” Version amendment 2 dated 02 March 2017.2/11/2018Dr. Hannah KibuukaMakerere University Walter Reed ProjectJanssen Vaccines and Prevention B.VOngoing
72.   0074A Randomized, Placebo-controlled Trial of HPV vaccination to reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-infected Women Participating in an HPV Test-and-Treat Program (CONVENANT)10/12/2018Dr. Jackson OremUganda Cancer InstituteNational Cancer Institute, Office of HIV and AIDS MalignancyTBC
73.   0075“Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old in Uganda.” Version 1.2, dated 26th March 201812/10/2018Dr. Irene LubegaInfectious Diseases InstituteCentre Of Disease ControlOngoing
74.   0076“A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavarin-free HCV Therapy to HCV Infected Populations who are HCV Treatment Naïve with Evidence of Active HCV Infection.” Version 1.0 dated 10 January 201826/11/2018Dr. Cissy KityoJoint Clinical Research CentreNational Institute of Allergy and Infectious Disease(NIAID)Ongoing
75.   0077“An Open-label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4 Month Treatment of Bedaquiline plus Pretomanid plus Moxifloxacin plus Pyrazinamide (BPaMZ) Compared to a 6 Month Treatment of HRZE/HR (Control) in Adult Participants with Drug- Sensitive Smear-Positive Pulmonary Tuberculosis (DS-TB) and a 6-month Treatment of BPaMZ in Adult Participants with Drug-Resistant, Smear-Positive Pulmonary Tuberculosis (DR-TB).” Version 2.0 dated 21 February 2018.4/12/2018Prof. Harriet Mayanja KizzaCase Western Reserve University Research CollaborationGlobal Alliance for TB Drug DevelopmentOngoing
76.   0078A Phase 2, Open-label, Multicentre, Single arm study to evaluate the Pharmacokinetics, Safety, Tolerability and Anti-Mycobacterial activity of TCM207 in combination with a Background regimen (BR) of Multidrug resistant Tuberculosis (MDR-TB) Medications for the treatment of children and adolescents 0 months to <18 years of age who have Confirmed or Probable Pulmonary Protocol TMC207-C211 Version; Amendment 6 dated 2 May 2019. 12/9/2019Dr. Rebecca NantandaMUCHS, Lung InstituteJanssen PharmaceuticalsOngoing
77.   0079“A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Pediatric Patients with Sickle Cell Disease (HESTIA3)''. Version 1 Dated 23 January 2018.23/1/2019Dr. Victor MusiimeJoint Clinical Research CentreAstra Zeneca AB, SwedenTerminated
78.   0080“Pharmacokinetic and Pharmacodynamic Evaluation of Etonogesterol Dose Escalation with Efavirenz based Antiretroviral Therapy in HIV-infected Ugandan Women (PK-20)’’ version 2.0 dated 20 November 2018.7/1/2019Dr. Mohammed LamordeInfectious Diseases instituteUniversity of PitsburgOngoing
79.   0081“Compassionate healthcare and frontline workers and ring vaccination project intended to evaluate safety of the Ebola vaccine in Uganda.” Version 1 Expanded Access-Uganda dated 05 September 201826/11/2018Dr. Bernard OparMinistry of Health Uganda supported by the world health OrganizationWorld Health OrganizationOngoing
80.   0084“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 19 October 2017.26/11/2018Dr. Nicolette Nabukeera BarungiBaylor College of Medicine Children’s FoundationNational Institute of Allergy and Infectious Disease(NIAID)Ongoing
81.   0086“Randomized trial to compare Magnesium Sulphate administration for preeclampsia and eclampsia: Springfusor versus standard approach” Version 6 Dated 22 December 2018.18/1/2019Dr. Sam OnongeDepartment of Obstetrics and Gynacology, Makerere University College of Health SciencesMakerere University College of Helath SciencesOngoing
82.   0087“A Randomized, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease (HESTIA3)''. Version 1 Dated 23 January 2018.30/1/2019Dr. Kibuuka AfiziInfectious Diseases Research CollaborationAstra ZeneccaNot Initiated
83.   0088“Effect of preoperative bicarbonate on Maternal and Perinatal outcomes of obstructed labour; A Study Protocol for a Randomized Controlled Trial” Version 1 Dated 14th September 2018.23/01/2019Dr. Milton Musaba WambokoDepartment of Obstetrics and Gynacology, Makerere University College of Health SciencesSurvival Pluss Project NORA/NORHED ProgramClosed Out
84.   0089“A Randomized, Four-arm Open-Label Phase iib Clinical Trial to Evaluate the Pharmacokinetics, Safety/Tolerability and Efficacy of High Dose Rifampicin in TB-HIV Co-infected patients on Efavirenze-or Dolutegravir based Antiretroviral Therapy (SAERIF)” Version 2.0 dated 25 september 201815/03/2019Dr. Christine SekaggyaInfectious Disease InstituteInfectious Disease InstituteOngoing
85.   0090A Phase I/II, Open-Label, Randomized Crossover Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/ - 30/15/40/10mg (4-in-1) Fixed Dose Combination vs Lopinavir/Ritonavir - 40/10mg pellets plus Dual Abacavir/Lamivudine - 60/30mg Tablets in HIV Infected Children.” Protocol Version 2.0 dated 19 September 2018.20/1/2019Dr. Victor MusiimeJoint Clinical Research CentreDrugs for Neglected Disease Initiative (DNDI)SwitzerlandOngoing
86.   0091“Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia (ACACIA).” Version 1.2 dated 14th March 2019.23/4/2019Dr. David MeyaInfectious Diseases InstituteInfectious Disease InstittuteOngoing
87.   0092“Optimizing benefits while reducing risks of iron in malaria-endemic areas: The OptiM” Protocol Version 1.6, dated 11 February 2019.15/3/2019Dr. Ezekiel MupereDepartment of Pediatrics and Child healthUniversity of MinnesotaOngoing
88.   0093“Population Difference in Vaccine Response: The Role, Reversibility and Mediators of Immunomodulation by Chronic Infections in the Tropics (POPVAC).” – Protocol A: The Effect of Intensive Treatment for Schistosomiasis on Response to Vaccines among Island Adolescents.28/5/2019Prof. Alison ElliotMRC-UVRI and LSHTMMedical Research CouncilOngoing
89.   0094“Population Difference in Vaccine Response: The Role, Reversibility and Mediators of Immunomodulation by Chronic Infections in the Tropics (POPVAC).” – Protocol C: The Impact of BCG ‘Pre-Immunisation’ on the Response to Vaccines among Ugandan Adolescents Participating in the Entebbe Mother and Baby Study.28/5/2019Prof. Alison ElliotMRC-UVRI and LSHTMLondon School of Hygiene and Tropical MedicineOngoing
90.   0095“A Randomized, Open-label, Parallel-group, Single Dose Regimen, Phase 2a Study to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) Given in Combination with Ferroquine (FQ) and FQ Alone, in African Patients with Uncomplicated Plasmodium Falciparum Malaria.” Version 1, dated 13 November 2017.2/5/2019Dr. Adoke YekaInfectious Diseases Research CollaborationSanofi-Aventis Recherche and Development and Medicines Malaria Venture MMVOngoing
91.   0096“Trial of Faropenem and Cefadroxil (in Combination with Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients with Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers.” Version 2.0 dated 28 January 201816/5/2019Dr. Cissy KityoJoint Clinical Research CentreNational University Hospital, 5 lower Kent Ridge Rd SingaporeOngoing
92.   0098Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Other Transfusion Transmitted Infections (Uganda Mirasol Trial).4/7/2019Dr. Irene LubegaMU-JHUDepartment of Defense, Congressionally Directed Medical Research ProgrammeOngoing
93.   0099“Pharmacokinetics ad Pharmacodynamics of Azithromycin in Severe Malaria Bacterial Co-infection in African Children: TABS PKPD Study” Version 1.2, dated 8th October 2018.25/11/2019Prof. Peter Olupot-OlupotMbale Clinical Research InstituteImperial College London. AIMI Vanden OevenOngoing
94.   0100Monitored Emergency Use of Unregistered and Experimental Drugs (MEURI): Favipiravir for Exposed Staff to Filovirus (Marbug and Ebola) in Uganda18/6/2019Prof. Juliet Mwanga AmumpaireMSF Epicenter MbararaMedicins Sans FrontieresOngoing
95.   0101Nucleosides and Darunavir/Dolutegravir in Africa (The NADIA Trial): A Randomised Controlled Trial of Darunavir versus Dolutegravir and Tenofovir versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa11/6/2019Dr. Andrew KambuguInfectious Disease InstituteInfectious Disease InstituteOngoing
96.   0102A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined with Local Standard of Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as a Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Children, Adolescents and Adults in Uganda7/4/2019Dr. Henry DdunguUCIFred Hutchinson Cancer Research CentreOngoing
97.   0103A Randomized, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagleror versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease11/6/2019MRC/UVRI and LSHTMAstra Zenecca ABTerminated
98.   0104“A Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® with or without AP 10-701 for Intestinal Schistosomiasis in Healthy Ugandan Adults.”28/8/2019Dr. Hannah KibuukaMUWRPBaylor College of MedicineOngoing
99.   0105Monitored Emergency Use for Ebola Virus Disease18/6/2019Dr. Francis KiweewaMUWRPJoint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) programClosed-Out
100.          0106An open-label, single arm study to provide additional information on immunogenecity and safety of Ad26.ZEBOV/MVA-BN-Filo"19/6/2019Prof. Pontiano KaleebuMRC/UVRI and LSHTMLondon School of Hygiene and Tropical Medicine LSHTMOngoing
101.          0107Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-Sensitive Tuberculosis (TRUNCATE-TB).” Version 1.2 dated 8th August 2016.16/8/2019Dr. Christine Sekaggya-WiltshireInfectious Disease InstituteUniversity College London. UOngoing
102.          0108Remdesivir (GS-5734): Monitored Emergency Use for Ebola Virus Disease. Version 6.0 dated 30 May 201918/6/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
103.          0109REGN3470-3471-3479: Monitored Emergency Use for Ebola virus Disease. Version 1.1 dated 20 September 201818/6/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
104.          0110ZMapp: Monitored Emergency Use for Ebola Virus Disease. Version 1.0 dated 16 December 201818/6/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
105.          0111A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumarate Switched to Tenofovir Alafenamide Fumarate based Anti-Retroviral Therapy. Version 2.0 dated 11 December 20184/9/2019Dr. Flavia Matovu KiweewaMU-JHU Research CollaborationGilead sciencesOngoing
106.          0112Combined HIV Adolescent PrEP and Prevention: On Demand Pre-Exposure Prophylaxis to Provide Protection from HIV in Men using Foreskin Tissue to Estimate Protection (CHAPS II) Version 1.2 dated 12 November 201819/9/2019Dr. Pontiano KaleebuMRC/UVRI and LSHTM Uganda Research InstitutePerinatal HIV Research Unit, Chris Hani Bagwaranth Academic Hospital, University of Witswater Rand UniversityOngoing
107.          0113Non-Inferiority Fractional-Doses Trial for Yellow Fever Vaccine. Version 1.3 dated 15 March 201923/9/2019Prof. Juliet Mwanga-AmumpaireEpicentre Mbarara Research CentreUniversity of Oxford UK. KEMRI-Welcome Trust Research ProgrammeOngoing
108.          0114Efficacy and Safety of fexinidazole in patients with Human African Trypanosomiasis (HAT) due to Trypanosoma brucei rhodesiense: a multicenter, open-label clinical trial Version 2.0 dated 16 Nov 201827/12/2019Prof Enock MatovuMakerere University, College of Veterinary Medicine, Animal Resources and BDrugs for Neglected Diseases Initiative DNDIOngoing
109.          0115A5300B/12003B/PHOENIx: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIX MDR-TB), Version 2.0, dated 25 September 201827/9/2019Dr. Henry MugerwaJoint Clinical Research CentreDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH), DHHSOngoing
110.          0116“A5300B/12003B/PHOENIx: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIX MDR-TB), Version 2.0, dated 25 September 2018”.21/10/2019Dr. Carolyne Peris OnyangoMU-JHUNational Institute of Allergy and Infectious Disease(NIAID),National Institute of Child Health and Human DevelopmentOngoing
111.          0117Population differences in vaccine response: the role, reversibility and mediators of immunomodulation by chronic infections in the tropics (POPVAC). – Protocol B: The effect of intermittent preventive treatment for Malaria with dihydroartemisinin –piperaquine on response to vaccines among rural adolescents. Version 1.4 dated 1st July 201911/9/2019Prof. Alison ElliottMRC-UVRI and LSHTMLondon School of Hygiene and Tropical Medicine LSHTMOngoing
112.          0118High Dose Oral Rifampicin to Improve Survival from Adult Tuberculosis Meningitis: A Double-blinded Randomised Controlled Phase III Trial. Version 1.1 dated 15th April 2019.23/12/2019Dr. David MeyaInfectious Disease InstituteInfectious Disease InstituteOngoing
113.          0119Empirical treatment against cytomegalovirus and tuberclosis in HIV-infected infants with severe pneumonia: A multicenter open label randomized controlled clinical trial, Version 1.3 dated 06 August 2019."11/3/2020Dr. Victor MusiimeMUCHSServicia Madrileno de Salud (SERMAS)-Fundacion para la Investigacion BiomedicaOngoing
114.          0120Birth Asphyxia in Uganda: Prevalence, Associated Factors and Effect of Intra-partum Oxygen Administration on Fetal and Early Neonatal Outcomes. Version 3.4 dated November 8, 2019 11/12/2019Ms. Elizabeth AyebareDepartment of Nursing, School of Health Sciences, Makerere University.Ayebare ElizabethOngoing
115.          0121‘Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRAVUDA® Use in Pregnancy”. Version 1 dated April 16, 20196/12/2019Dr. Clemensia NakabittoMU-JHUDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH),Ongoing
116.          0122"Impaact of increased praziquantel frequency on childhood fibrosis in persistent schistosmiasis morbility hotspots (FibroScoHot)" Version 1.4 dated 14 Oct 201923/1/2020Dr. Edridah TukahebwaVector Control DivisionCambridge University Hospital NHS Foundation TrustOngoing
117.          0124"Safety and efficacy of Dolutegravir and EFV400 for pregnant and breatfeeding women: a randomised non-inferiority clinical trial.8/5/2020Dr. Jackson MukonzoDepatment of pharmacology and Therapeutics, MAKCHSHawassa UniversityOngoing
118.          0125A phase 11b three-arm, two-stage HIV-1 prophylactic vaccine trial with a secod randomisation to comapare TAF/FTC in comparison to TDF/FTC as pre-exposure prophylaxis (PrEPVacc)26/3/2020Prof Pontiano KaleebuMRC/UVRIJonathan Weber, Imperial College, Room 2.15, 2 Floor, Faculty Building, South Kesington campus, Exhibition road, LondonOngoing
119.          0126A Phase 3, Open-label, Dose Escalation Study to Determine the Pharmacokinetics of Atazanavir administered with Rifampicin to HIV Positive Adults on Second-line ART Regimen with Suppressed HIV-1 Viral Load (DERIVE).” Version 3.0 dated 04 March 202022/5/2020Dr. Henry MugerwaJoint Clinical Research CentreUniversity of LiverpoolOngoing
0128DPART Study Dihydroatemisinin in the context of Antiretroviral Therapy" Version 1.1 Dated 22 April 201930/7/2020Dr Grace Paul KisituBaylor College of Medicine , Childrens FoundationNational Institute of Child Health and Human Development (NICHD)Ongoing
0129A multicenter, phase III double blind, randomzed active controlled study to evaluate the efficacy and safety of VPM1002 in comparison with BCG in prevention of Mycobacterium tuberculosis infection in new born infants8/7/2020Dr. Victoria NankabirwaMakerere University School of Public HealthSerum Institute of India, Private LimitedOngoing
120.          0131Rosuvastatin evaluation as a tuberculosis treatment adjunct (rosetta) version 1.0 dated 15 november 201913/3/2020Dr. Cissy Kityo MutuluuzaJoint Clinical Research CenterNational University HospitalOngoing
121.          0132Impaact of oral step-down to amoxicillin or co-amoxiclav and duration of antibiotic therapy on effectiveness, safety and selection of antibiotic resistance inn severe childhood community-acquired pneumonia (CAP): a randomized controlled trial15/6/2020DR Victor MusiimeDepartment of pediatrics and child healthFONDAZIONE PENTA ONLUSOngoing
0133Praziquantel for children under age four years:A phase ii PK/PD driven dose finding trial (PIP)27/7/2020Dr Patrice MawaMRC/UVRI AND LSHTMRhode Island Hospital, Center for International Health ResearchOngoing
122.          0134Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CABLA) for Prevention of HIV among Female Adolescents-A Sub-study of HPTN084.26/6/2020Dr Brenda Gati MirembeMU-JHUDivision of AIDS(DAIDS), United States (US) National Institute of Allergy and Infectious Disease(NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), US National Institute of Health (NIHOngoing
0135Optimal chemopreventive regimens to prevent malaria and improve birth in Uganda, Version 2.0 dated 12 December 201930/7/2020Prof Moses KamyaIDRCThe National Institute of Cild Health and Human Development (NICHDOngoing
0136Pharmacokinetics and tolerability of Adjunctive Linezolid for the Treatment of tubERculous meningitis (ALTER): a Phase II trial, open-label, randomized trial” Version 1.0 Dated April 3 rd , 2019.11/9/2020Dr Freddie Mukasa KibengoMRC/UVRI & London School of Hygiene and Tropical MedicineUniversity of California, San FranciscoOngoing
0137Comparison of Mortality and Frequency of Red Blood Cell Alloimunization in recipients of Leukreduced and Non-Leukoreduced Blood Transfusion in Uganda.9/22/2020Dr Clememt OkelloUganda Cancer InstituteUganda Cancer InstituteOngoing
0138Randomised controlled non-inferiority trial of topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in East Africa30/9/2020Dr Simon ArungaMbarara University and Referral Eye CenterLondon School of Hygiene and Tropical MedicineOngoing
0139The safety and immunogenicity of a combined Pertusis-containing vaccine (Tdap) for HIV-infected pregnant women and their newborns-A randomised Clinical Trial (woMANPOWER)." Protocol Version 3.0 dated 03 March 2020.23/9/2020Dr Eva NakabembeMakerere University College of Health SciencesSt Georges University of LondonOngoing
0143The Efficacy and Safety of hydroxychloroquine for the treatment of non-severe covid-19 in adults in Uganda. A randomised open label phase II clinical trial, Version 1.1 dated 13 July 20209/9/2020Dr Pauline Byakika-KibwikaMakerere University College of Health SciencesMakerere UniversityOngoing
0146Assessment of safety and efficacy of COVID-19 Convaslecent Plasma for treatment of COVID-19 in adults in Uganda; A phase III randmized controlled trial (CCP). Version 2.0 dated July 2020.14/9/2020Dr Bruce KirengaMULIMakerere UniversityOngoing
Abbreviations
1.      MUCHSMakerere University College of Health Sciences
2.      MU-JHUMakerere University – John Hopkins University
3.      MU-UCSFMakerere University – University of California, San Francisco
4.      MRC/UVRIMedical Research Council / Uganda Virus Research Institute
5.      UVRI-IAVIUganda Virus Research Institute – International AIDS Vaccine Initiative
6.      LSHTMLondon School of Hygiene and Tropical Medicine

*TBC= To Be Confirmed

Abbreviations

1. MUCHS           Makerere University College of Health Sciences
2. MU-JHU          Makerere University – John Hopkins University
3. MU-UCSF        Makerere University – University of California, San Francisco

4. MRC/UVRI       Medical Research Council / Uganda Virus Research Institute
5. UVRI-IAVI         Uganda Virus Research Institute – International AIDS Vaccine Initiative
6. LSHTM            London School of Hygiene and Tropical Medicine