Madibeng Centre for Research

Research

Would you like to be part of the research programme?

Protocol NoPhaseTitleTotal No of ParticipantsYear
444563/013
(Rota-013)
IIA phase II, randomized, double-blind, placebo-controlled study of the safety, reactogenicity and immunogenicity of two or three doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at different viral concentrations (105.0 ffu and 106.0 ffu) in healthy infants (approximately 6 weeks old) in South Africa.852003 - 2004
759346/007 (DTPwHB/HibMenACTT007)IIIA phase III, open, randomized, controlled primary vaccination study to demonstrate the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine when mixed extemporaneously and given as a single injection with GSK Biologicals’ TritanrixTM-HepB/HiberixTM with respect to the immunogenicity of the hepatitis B antigen, when administered to healthy infants at 6, 10 and 14 weeks of age after a birth dose of hepatitis B vaccine.512004-2005
102248/037
(Rota-037)
Cohort 1
IIIA phase III, double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South Africa.2582005 -2007
104756IIIA phase III open, single centre booster vaccination study to assess safety and reactogenicity of a dose of DTPw-HBV/Hib vaccine given at 15-18 months of age and to assess the immunogenicity, safety and reactogenicity of a dose of MencevaxTM ACW vaccine given at 24 to 30 months of age in subjects primed in study 759346/007432006 -2007
444563/022
(Rota-022)
IIA phase II, double-blind, randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa202005 -2008
102248/037
(Rota-037)
Cohort 2
IIIA phase III, double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South Africa.2152006 – 2007
IPM 100Epidemio-
logical
A Cross-Sectional And Prospective, Observational, Cohort Study To Estimate HIV Incidence Among Sexually Active Adult Females8002007 -2008
111274/037
(Rota-037)
Cohort 2 Year 2 extension
IIIA phase III, double-blind, randomized, placebo-controlled, multi-center study to assess the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants in South Africa.1732007 - 2008
CFAM810A2310IIIA randomised, multicentre, double-blind study to compare the efficacy of single-day treatment (1000mg b.i.d) with Famciclovir compared to that of placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients62008
CSPA100A2305IIIAn 8-week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren administered alone and in combination with amlodipine in patients with essential hypertension32009
IPM014BIIA double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and acceptability of dapivirine gel 4789, 0.05% 2.5g, a vaginal microbicide, conducted using daily monitored adherence in healthy HIV-negative women362009-2010
IPM014AIIA double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and acceptability of dapivirine gel 4759, 0.05% 2.5g, a vaginal microbicide, conducted using daily monitored adherence in healthy HIV-negative women402010
IPM 015IIA double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety of an intravaginal matrix ring with dapivirine in healthy HIV-negative women402010
REMoxTBIIIA randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely
1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and
2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis
522010 - 2013
IPM 027IIIA Multi-centre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-negative Women4822012 – 2016
IPM 007EpidemiologicaA long-term follow-up cohort study of HIV infection in participants who seroconvert after enrolment in Dapivirine Vaginal Ring trials242012 - 2020
EXSCELIIIA Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with exenatide once weekly in Patients with Type 2 Diabetes Mellitus32015 - 2017
STAND (NC-006)IIIA Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis.82015 – 2018
IPM 032IIIBA Follow-On, Open-Label Trial To Assess Continued Safety Of and Adherence To The Dapivirine (25 Mg) Vaginal Ring-004 In Healthy, HIV-Negative Women2342016 – 2019
ECHOIVA Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)4072016 – 2019
SimpliciTB (NC-008)IIBAn 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)322018 – 2022
2019nCOV-501II A/BA Phase 2a/b, randomized, observer-blinded, placebo controlled study to evaluate the efficacy, immunogenicity, and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant in South African adult subjects living without HIV; and safety and immunogenicity in adults living with HIV2072020 - 2022
MK8591-022 (IMPOWER-022)IIIA Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection882021 - current
Sinovac PRO-nCoV-3002IIIA Multi-center, Randomized, Double-blind, Placebo-controlled Phase ? Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated (CoronaVac®) in Children and Adolescents Aged 6 months to 17 Years.4502021 – 2023
GS-US-412-5624IIIA Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection28 and enrolling2021 - current
GT-0918-US-3001IIIA Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Male Outpatients with Mild to Moderate COVID-19 Illness02021 – 2022
C4671006II/IIIA Phase 2/3, Randomized, Double-Blind, Double-Dummy, Placebocontrolled Study To Evaluate The Safety And Efficacy Of 2 Regimens Of Orally Administered Pf07321332/Ritonavir In Preventing Symptomatic SARS-CoV-2 Infection In Adult Household Contacts Of An Individual With Symptomatic COVID-1912021 - 2022
C4671002II/IIIAn Interventional Efficacy And Safety, Phase 2/3, Double-Blind, 2-Arm Study To Investigate Orally Administered Pf-07321332/Ritonavir Compared With Placebo In Nonhospitalized Symptomatic Adult Participants With COVID-19 Who Are At Low Risk Of Progressing To Severe Illness02022
VAC18192RSV3002IIIA Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older35 and recruiting2022 - current
2019-nCoV-505IIA Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M™Adjuvant in People Living with HIV342022 - current
INSIGHTN/AA cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women1502023 - current