Clinical Trials authorized in Uganda since 2016 – Updated on 28th July 2020

S/NCTA #TitleDate of initial AuthorizationPrincipal InvestigatorInstitutionSponsorStatus
10001"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
20002"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
30003"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 Care Ltd.United States National Institute of HealthOngoing
40004"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-UCSFOngoing
50005"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
60006"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
70007"Pharmacokinetics of efavirenz 400 mg once daily during pregnancy in HIV -1 infected women."7/7/2016Dr. Mohammed LamordeInfectious Disease InstituteClosed out
80008"Investigation of rheumatic AF Treatment Using Vitamin K antagonists, rivaroxaban or aspirin Studies. (INVICTUS)"12/12/2016Dr. Emmy OkelloUganda Heart InstitutePopulation Health Research InstituteOngoing
90009"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
100010"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
110011"A Pharmacokinetic Evaluation of Increased Dose Levonorgestrel Implant and Efavirenz-Based Antiretroviral Therapy In HIV-Infected Women"10/3/2017Dr. Mohammed LamordeInfectious Diseases InstituteOngoing
120012"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
130013"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
140014"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
150015"Defining the Molecular profile of Breast Cancer in Uganda and its Clinical Implications" 2/3/2017Dr. Jackson OremUganda Cancer InstituteGSKOngoing
160016"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 2016 28/03/2017Dr. Robert Opika OpokaGlobal Health Uganda / Pediatric Department, Mulago Hospital Doris Duke Chariatable FoundationOngoing
170017"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, Mulago HospitalUniversity of CopenhagenTerminated
180018A 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 CentreGilead SciencesOngoing
190019"Anti-retroviral therapy for acute HIV infection" Version 1.5 dated 16th August 201715/02/2018Dr. Francis KiweewaMakerere University Walter Reed Project.Henry M Jackson Foundation,United States Military HIV Research ProgramClosed out
200021"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
210022"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 NsambyaUniversity of AbujaTBC
220023"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 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
230024"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 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
240025"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 BaseSt George University of LondonOngoing
250026"Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial"26/04/2017Dr. Cissy Kityo MutuluuzaJoint Clinical Research CentreOngoing
260027"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 InstituteThe International Union Against the TB and Lung Disease (IUATLD)Ongoing
270028"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 BaseSt George University of LondonOngoing
280029"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 InstituteOxford UniversityOngoing
290030"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/UVRILondon School of Hygiene and Tropical MedicineOngoing
300031"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 InstituteThe International Union Against the TB and Lung Disease (IUATLD)Ongoing
310032"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
320033"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 InstituteMahidol Oxford Research Unit-University of OxfordOngoing
330034"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 InstituteOxford UniversityOngoing
340035"Randomized Trial to Prevent Vascular Events in HIV-REPRIEVE" Protocol No: A5332, Version 3.0 dated 28th January 201627/09/2017Prof. Cissy Kityo MutuluuzaJoint Clinical Research CentreDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH),Ongoing
350036"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 care Ltd.Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID)Ongoing
360037"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
370038"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
380039"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
390040"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
400041"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
410042"Randomized Trial to Prevent Vascular Events in HIV-REPRIEVE" Protocol No: A5332, Version 3.0 dated 28th January 201627/09/2017Prof. Cissy Kityo MutuluuzaJoint Clinical Research CentreDivision of AIDS (DAIDS), National Institute of Allergy and Infectious Disease(NIAID),National Institute of Health (NIH),Ongoing
420043"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
430044"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
440045"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
450046Optimizing 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
460047"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
470048"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
480049"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
490050"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
500051"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
510052"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
520053"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
530054"Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women." Version 2.1, Dated 12th July 201717/04/2018Professor Elly KatabiraInfectious Diseases InstituteUniversity of Washington,Ongoing
540055"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 InstituteInfectious Disease InstituteOngoing
550056"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
560057"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
570058"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
580059"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
590061"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
600062"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 CentreNovartis Pharma AGClosed Out
610063"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
620064"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
630065"Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women." Version 2.1, Dated 12th July 201717/04/2018Professor Elly KatabiraInfectious Diseases InstituteUniversity of Washington,Ongoing
640066"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 InstituteInfectious Disease InstituteOngoing
650067"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 InstituteInfectious Disease InstituteOngoing
660068"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
670069"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
680070"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 InstituteUniversity of WashingtonOngoing
690071"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 InstituteInfectious Disease InstituteOngoing
700072"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 CollaborationNational Institute of Allergy and Infectious Disease(NIAID)Ongoing
710073"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 UnitUniversity of oxford clinical trials and Research Governance Joint Research OfficeOngoing
720074High 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 InstituteLondon School of Hygiene and Tropical Medicine (LSHTM)Ongoing
730075"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 CentrePENTA FoundationOngoing
740076"Children with HIV in Africa - Pharmacokinetics and Acceptability of Simple Second-line Anti-Retroviral Regimens." Version 2.0 dated 8th November 201729/07/2018Dr. Victor MusiimeJoint Clinical Research CenterUniversity College of LondonOngoing
750077"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
760078"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 201720/08/2018Dr. Emmy OkelloUganda Heart InstituteChildren?s National Medical CentreOngoing
770079"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
780080"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
790081"Zinc for Infection Prevention in Sickle Cell Anaemia (ZIPS)" Version 1.0, dated 19th March 201823/08/2018Dr. Robert OpokaDepartment of Pediatrics and Child Health, MUCHSThrasher Research FundOngoing
800084"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 201721/09/2018Dr. Juliet Mwanga AmumpaireEpicenter Mbarara Research CenterMedicins Sans FrontieresOngoing
810086"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
820087A 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
830088"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
840089"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 Na?ve 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
850090"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
860091A 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 have12/9/2019Dr. Rebecca NantandaMUCHS, Lung InstituteJanssen PharmaceuticalsOngoing
870092"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 2018.23/01/2019Dr. Victor MusiimeJoint Clinical Research CentreAstra Zeneca AB, SwedenTerminated
880093"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
890094"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
900095"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
910096"Randomized trial to compare Magnesium Sulphate administration for preeclampsia and eclampsia: Springfusor versus standard approach" Version 6 Dated 22 December 2018.18/01/2019Dr. Sam OnongeDepartment of Obstetrics and Gynacology, Makerere University College of Health SciencesMakerere University College of Helath SciencesOngoing
920098"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 2018.30/01/2019Dr. Kibuuka AfiziInfectious Diseases Research CollaborationAstra ZeneccaOngoing
930099"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
940100"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
950101"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
960102A 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
970103A 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 2018.20/01/2019Dr. Victor MusiimeJoint Clinical Research CentreDrugs for Neglected Disease Initiative (DNDI)SwitzerlandOngoing
980104"Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia (ACACIA)." Version 1.2 dated 14th March 2019.23/04/2019Dr. David MeyaInfectious Diseases InstituteInfectious Disease InstittuteOngoing
990105"Optimizing benefits while reducing risks of iron in malaria-endemic areas: The OptiM" Protocol Version 1.6, dated 11 February 2019.15/03/2019Dr. Ezekiel MupereDepartment of Pediatrics and Child healthUniversity of MinnesotaOngoing
1000106"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.28/05/2019Prof. Alison ElliotMRC-UVRI and LSHTMMedical Research CouncilOngoing
1010107Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-Sensitive Tuberculosis (TRUNCATE-TB)." Version 1.2 dated 8th August 2016.16/08/2019Dr. Christine Sekaggya-WiltshireInfectious Disease InstituteUniversity College London. UOngoing
1020108"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.28/05/2019Prof. Alison ElliotMRC-UVRI and LSHTMLondon School of Hygiene and Tropical MedicineOngoing
1030109REGN3470-3471-3479: Monitored Emergency Use for Ebola virus Disease. Version 1.1 dated 20 September 201818/06/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
1040110"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
1050111"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 201816/05/2019Dr. Cissy KityoJoint Clinical Research CentreNational University Hospital, 5 lower Kent Ridge Rd SingaporeOngoing
1060112Randomized 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
1070113"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
1080114Monitored 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
1090115Nucleosides 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
1100116"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
1110117A 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
1120118A 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
1130119Empirical 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
1140120Birth 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
1150121"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
1160122Monitored Emergency Use for Ebola Virus Disease18/6/2019Dr. Francis KiweewaMUWRPJoint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) programOngoing
1170124An open-label, single arm study to provide additional information on immunogenecity and safety of Ad26.ZEBOV/MVA-BN-Filo"19/06/2019Prof. Pontiano KaleebuMRC/UVRI and LSHTMLondon School of Hygiene and Tropical Medicine LSHTMOngoing
1180125A 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
1190126Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-Sensitive Tuberculosis (TRUNCATE-TB).? Version 1.2 dated 8th August 2016.16/08/2019Dr. Christine Sekaggya-WiltshireInfectious Disease InstituteUniversity College London. UOngoing
1200131Remdesivir (GS-5734): Monitored Emergency Use for Ebola Virus Disease. Version 6.0 dated 30 May 201918/06/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
1210132REGN3470-3471-3479: Monitored Emergency Use for Ebola virus Disease. Version 1.1 dated 20 September 201818/06/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing
1220134ZMapp: Monitored Emergency Use for Ebola Virus Disease. Version 1.0 dated 16 December 201818/06/2019Dr. Bernard OparMinistry of HealthMedicins Sans FrontieresOngoing

*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