Clinical Trials authorized in Uganda since 2016 – Updated on 30th September 2019

 SNCTA #TitleDate of initial AuthorizationPrincipal InvestigatorInstitutionStatus
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
04/04/2016Dr. Robert Opika OpokaDepartment of Pediatrics and Child Health, MUCHS Ongoing
2.       0002"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.       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 201319/05/2016Dr. Linda Barlow MoshaMU-JHU Research CollaborationOngoing
4.       0004"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.       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 201411/05/2016Dr. 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 2015.15/07/2016Dr. Cissy Kityo MutuluzaJoint Clinical Research CentreOngoing
7.       0007"Pharmacokinetics of efavirenz 400 mg once daily during pregnancy in HIV -1 infected women."07/07/2016Dr. Mohammed LamordeInfectious Diseases InstituteClosed out
8.       0008"Investigation of rheumatic AF Treatment Using Vitamin K antagonists, rivaroxaban or aspirin Studies. (INVICTUS)" 12/12/2016Dr. Emmy OkelloUganda Heart 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 201405/09/2016Dr. Brenda Gati MirembeMUJHU Research CollaborationOngoing
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
02/09/2016Prof. Pontiano KaleebuMRC/UVRI and LSHTM Uganda Research UnitOngoing
11.   0011"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.   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" 01/11/2016Dr. Henry MugerwaJoint Clinical Research CentreOngoing
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/UVRI and LSHTM Uganda Research UnitClosed out
14.   0014"Strategy for Maintenance of HIV Suppression with Elvitegravir + Darunavir +Ritonavir in Children (SMILE PROTOCOL)"06/02/2017Dr. Victor MusiimeJoint Clinical Research CentreAmended to CTA0065
15.   0015"Defining the Molecular profile of Breast Cancer in Uganda and its Clinical Implications"02/03/2017Dr. Jackson OremUganda Cancer InstituteOngoing
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 201628/03/2017Dr. Robert Opika OpokaGlobal Health Uganda / Pediatric Department, Mulago Hospital Ongoing
17.   0017"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 HospitalTerminated
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 Children17/03/2017Dr. Eva NatukundaJoint Clinical Research CentreOngoing
19.   0019"Anti-retroviral therapy for acute HIV infection" Version 1.5 dated 16th August 201715/02/2018Dr. Francis KiweewaMUWRPOngoing
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 201610/03/2017Prof. Pontiano KaleebuMRC/UVRI and LSHTM Uganda Research UnitClosed out
21.   0022"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 NsambyaTBC
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 201614/06/2017Dr. Jesca NakibuukaMU-JHU Research CollaborationOngoing
23.   0024"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.   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)"14/06/2017Dr. Daniel AtwineEpicentre - Mbarara Research BaseOngoing
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 201729/03/2017Prof. Janet SeeleyMRC/UVRI and LSHTM Uganda Research UnitOngoing
26.   0027"The evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TB (STREAM)" Version 6.2 dated February 201523/05/2017Dr. Bruce KirengaMakerere University – Lung InstituteOngoing
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 201622/06/2017Dr. Peter Olupot-OlupotMbale Clinical Research InstituteOngoing
28.   0029"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.   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 201629/09/2017Dr. Deo WabwireMU-JHU Research CollaborationOngoing
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 201711/08/2017Dr. 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 UgandaOngoing
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 Research CollaborationOngoing
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 2017.04/10/2017Dr. Patrick KazoobaEpicentre - Mbarara Research CentreOngoing
34.   0035"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.   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 201611/12/2017Prof. Peter MugyenyiJoint Clinical Research CentreOngoing
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 201709/03/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
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"10/01/2018Dr. Sylvia KusemererwaMRC/UVRI and LSHTM Uganda Research UnitOngoing
38.   0039Optimizing 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.   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 UniversityOngoing
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 ProgramOngoing
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 InstituteOngoing
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 InstituteOngoing
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 201709/07/2018Dr. Carolyne Agwau AkelloMU-JHU Research CollaborationOngoing
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 2017.03/01/2018Dr. Mohammed LamordeInfectious Diseases InstituteClosed out
45.   0046"HIV Self-testing to empower Prevention Choices in Sex workers." Protocol version 1.6 dated 28th July 201703/01/2018Dr. Andrew MujugiraInfectious Diseases InstituteOngoing
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 201708/11/2018Dr. Darlsone KwarisiimaInfectious Disease Research CollaborationOngoing
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 2017.04/04/2018Dr. Patricia Nahirya NtegeBaylor College of Medicine Children’s FoundationOngoing
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 2017.06/03/2018Dr. Henry MugerwaJoint Clinical Research CentreOngoing
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 201728/02/2018Dr. Stephen AsiimweKabwohe Clinical Research CentreOngoing
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 2017.06/02/2018Dr. Cissy Kityo Mutuluuza,Joint Clinical Research CentreOngoing
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 201703/01/2018Professor Elly KatabiraInfectious Diseases InstituteOngoing
53.   0054"Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women." Version 2.1, Dated 12th July 201717/04/2018Professor Elly KatabiraInfectious Diseases InstituteOngoing
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 201726/06/2018Prof. Mohammed LamordeInfectious Diseases 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 2017.27/06/2018Prof. Mohammed LamordeInfectious Diseases 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 2017.01/03/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
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 201704/04/2018Dr. Juliet MpendoUganda Virus Research Institute-International AIDS Vaccine InitiativeOngoing
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 201621/06/2018Prof. Elly KatabiraInfectious Diseases InstituteOngoing
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 2018.18/06/2018Dr. David B. MeyaInfectious Diseases 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 2017.22/06/2018Dr. Clemensia NakabiitoMUJHU Research CollaborationOngoing
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 2018
20/07/2018Prof. Alison ElliotMRC/UVRI and LSHTM Uganda Research UnitOngoing
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 201822/06/2018Dr. David MeyaInfectious Diseases InstituteOngoing
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 201722/06/2018Dr. Victor MusiimeJoint Clinical Research CentreOngoing
64.   0066"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 CentreOngoing
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 201804/07/2018Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
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 201720/08/2018Dr. Emmy OkelloUganda Heart InstituteOngoing
67.   0069"Encochleated Oral Amphotericin for Cryptococcal Meningitis (EnACT)". Version 0.7.6, dated 1st November 2017.04/10/2018Dr. David B. MeyaInfectious Diseases InstituteOngoing
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 MwesigwaMUWRPOngoing
69.   0071"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, MUCHSOngoing
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 201721/09/2018Dr. Juliet Mwanga AmumpaireEpicenter Mbarara Research CenterOngoing
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 2017.02/11/2018Dr. Hannah KibuukaMUWRPOngoing
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 InstituteTBC
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 InstituteOngoing
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 CentreOngoing
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 2018.04/12/2018Dr. Alphonse OkweraCase Western Reserve University Research CollaborationOngoing
76.   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 2018.23/01/2019Dr. Victor MusiimeJoint Clinical Research CentreOngoing
77.   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 2018.07/01/2019Dr. Mohammed LamordeInfectious Diseases instituteOngoing
78.   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 OrganizationOngoing
79.   0084"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. Violet KorutaroBaylor College of Medicine Children’s FoundationOngoing
80.   0086"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 Gynecology, Makerere University College of Health SciencesOngoing
81.   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 2018.30/01/2019Dr. Kibuuka AfiziInfectious Diseases Research CollaborationOngoing
82.   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 Gynecology, Makerere University College of Health SciencesOngoing
83.   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 InstituteOngoing
84.   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 2018.20/01/2019Dr. Victor MusiimeJoint Clinical Research CentreOngoing
85.   0091"Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia (ACACIA)." Version 1.2 dated 14th March 2019.23/04/2019Dr. David MeyaInfectious Diseases InstituteOngoing
86.   0092"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 healthOngoing
87.   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.28/05/2019Prof. Alison ElliotMRC-UVRI and LSHTM Uganda Research InstituteOngoing
88.   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.28/05/2019Prof. Alison ElliotMRC-UVRI and LSHTM Uganda Research InstituteOngoing
89.   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 2017.02/05/2019Dr. Adoke YekaInfectious Diseases Research CollaborationOngoing
90.   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 201816/05/2019Dr. Cissy KityoJoint Clinical Research CentreOngoing
91.   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 Africa11/06/2019Dr. Andrew KambuguInfectious Disease InstituteOngoing
92.   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 Disease11/06/2019MRC/UVRI and LSHTM Uganda Research InstituteOngoing
93.   0104A Phase I/II Study of the Safety, Reactogenicity and Immunogenicity of the Sm-TSP-2/Alhydrogel with or without AP 10-701 for Intestinal Schistosomiasis in Health Ugandan Adults. Version 3.0 dated 24 June 201928/08/2019Dr. Hannah KibuukaMUWRPTBC
94.   0106An open-label, single arm study to provide additional information on immunogenicity and safety of Ad26.ZEBOV/MVA-BN-Filo"19/06/2019Prof. Pontiano KaleebuMRC/UVRI and LSHTMOngoing
95.   0107Two-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. Lydia NakiyingiInfectious Disease InstituteOngoing
96.   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 201804/09/2019Dr. Flavia Matovu KiweewaMU-JHU Research CollaborationOngoing
97.   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 201819/09/2019Dr. Pontiano KaleebuMRC/UVRI and LSHTM Uganda Research InstituteOngoing
98.   0113Non-Inferiority Fractional-Doses Trial for Yellow Fever Vaccine. Version 1.3 dated 15 March 201923/09/2019Prof. Juliet Mwanga-AmumpaireEpicentre Mbarara Research CentreOngoing
99.   0115A5300B/12003B/PHOENIx: Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIX MDR-TB), Version 2.0, dated 25 September 201827/09/2019Dr. Henry MugerwaJoint Clinical Research CentreOngoing
100.           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-JHU Research CollaborationOngoing

*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. MUWRP          Makerere University Walter Reed Project
5. MRC/UVRI       Medical Research Council / Uganda Virus Research Institute
6. UVRI-IAVI         Uganda Virus Research Institute – International AIDS Vaccine Initiative
7. LSHTM            London School of Hygiene and Tropical Medicine