Generating Knowledge - Impacting Health
CTU Studies
| NETWORK | CLINICAL RESEARCH SITE | TITLE | PRINCIPAL INVESTIGATOR/S |
| ONGOING | |||
| MTN | eThekwini | MTN 015: An Observational Cohort Study of Women following HIV-1 seroconversion in Microbicide Trials. | Dr Leila Mansoor |
| MTN | eThekwini | MTN 016: HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study. | Dr Leila Mansoor |
| MTN | eThekwini | MTN 025: A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women. | Dr Leila Mansoor |
| MTN | eThekwini | MTN 032: Assessment of ASPIRE and HOPE Adherence: An exploratory sub-study of the ASPIRE and HOPE trials that will utilize qualitative In-Depth Interviews (IDIs) and Focus-Group Discussions (FGDs) | Dr Leila Mansoor |
| HVTN | eThekwini | HVTN100: A phase 1/2 randomized, double-blind, placebo- controlled clinical trial of clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C p120/MF59® in HIV | Dr Kathryn Mngadi/ Prof Quarraisha Abdool Karim |
| HVTN | eThekwini | HVTN 108: A phase 1/2a clinical trial to evaluate the safety and immunogenicity of HIV clade C DNA, NYVAC-HIV, and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants. | Dr Kathryn Mngadi |
| HVTN | eThekwini | HVTN 703: A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection. | Dr Kathryn Mngadi/ Prof Quarraisha Abdool Karim |
| HVTN | eThekwini | HVTN 702: A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in preventing HIV-1 infection in adults in South Africa | Dr Kathryn Mngadi/ Prof Quarraisha Abdool Karim |
| HPTN | Vulindlela | HPTN 077: A Phase IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Investigational Injectable HIV Integrase Inhibitor, GSK1265744, in HIV-uninfected Men and Women | Prof Quarraisha Abdool Karim/ Site PI: Dr Halima Dawood |
| IMPAACT | Umlazi | IMPAACT 1077BF Sub-study: ARV Adherence and Exposure – Hair sub-study | Dr Daya Moodley/ Prof Quarraisha Abdool Karim |
| IMPAACT | Umlazi | IMPAACT P1090: A Phase I/II, open-label trial to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of Etravirine (ETR) in Antiretroviral treatment-experienced HIV-1 infected infants and children, aged >2months to <6years. | Dr Kimesh Naidoo/ Prof Daya Moodley/ Prof Quarraisha Abdool Karim |
| IMPAACT | Umlazi | IMPAACT P1115: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study. | Dr Kimesh Naidoo/ Prof Daya Moodley/Prof Quarraisha Abdool Karim |
| IMPAACT | Umlazi | IMPAACT P1093: A Phase I/II, Multi Centre, Open-Label Pharmacokinetic, Safety, Tolerability, and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents | Dr Moherndran Archary/ Prof Daya Moodley/ Prof Quarraisha Abdool Karim |
| IMPAACT | Umlazi | IMPAACT 2007: Phase 1 Safety and Pharmacokinetic Study of Maraviroc in HIV-1 Exposed Infants at Risk of Acquiring HIV-1 Infection. IND # 130,613. | Dr Sherika Hanley/ Prof Daya Moodley/ Prof Quarraisha Abdool Karim |
| COMPLETED | |||
| MTN | eThekwini | MTN 020: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 infection in Women. | Dr Gonasagrie Nair |
| IMPAACT | Umlazi | IMPAACT 1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) | Dr Daya Moodley |
| IMPAACT | Umlazi | IMPAACT P1084s: Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health. | Dr Daya Moodley |
| IMPAACT | Umlazi | IMPAACT P1110: A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-exposed neonates at high risk of acquiring HIV-1 infection. | Dr Megeshinee Naidoo/ Dr Daya Moodley/ Prof Quarraisha Abdool Karim |
| AACTG | eThekwini | A5221 : STRIDE: A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis with CD4 < 250 Cells/mm3 | Dr Nesri Padayatchi |
| AACTG | eThekwini | AACTG A5253: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals | Dr Nesri Padayatchi |
| AACTG | eThekwini | AACTG A5255: Faster AFB Identification, Speciation of TB, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Treatment | Dr Nesri Padayatchi |
| AACTG | eThekwini | AACTG A5274: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens | Dr Nesri Padayatchi |
| AACTG | eThekwini | AACTG A5304: Controlled comparison of two moxifloxacin containing treatment shortening regimens with the standard regimen in pulmonary tuberculosis | Dr Nesri Padayatchi |
| HVTN | eThekwini/ Aurum | HVTN 503: A multicenter double-blind randomized placebo-controlled Phase IIB test-of-concept study to evaluate the safety and efficacy of a 3-dose regimen of the Clade B-based Merck Adenovirus serotype 5 HIV-1 gag/pol/nef vaccine in HIV-1-uninfected adults in South Africa | Prof Koleka Mlisana/ Prof Gavin Churchyard |
| HVTN | eThekwini/ Aurum | HVTN 082: A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials | Dr Craig Innes |
| MTN | eThekwini/ Aurum | MTN 003: Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women | Dr Gonasagrie Nair/ Prof Gavin Churchyard |
| HPTN | Umlazi | HPTN 046: Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV Infected Women to Prevent Vertical HIV Transmission During Breastfeeding | Dr Daya Moodley |
| HVTN | Aurum | HVTN 204: A placebo-controlled phase II clinical trial to evaluate the safety and Immunogenicity of a multiclade HIV-1 DNA plasmid vaccine, VRC-HIVDNA016-00-VP, followed by a multiclade recombinant adenoviral vector vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adult participants | Prof Gavin Churchyard |
| HVTN | Aurum | HVTN 404: Long-term follow-up of HIV-1 Infection in participants who become infected after enrolment in early-phase (Phase 1 and 2a) HIV vaccine protocols or HIV | Dr Craig Innes |
| HVTN | Aurum | HVTN 086: A phase 1 placebo-controlled clinical trial to evaluate the safety and immunogenicity of SAAVI DNA-C2, SAAVI MVA-C and Novartis subtype C gp140 with MF59 adjuvant in various vaccination schedules in HIV-uninfected healthy vaccinia-naïve adult participants in South Africa | Prof Gavin J Churchyard/ Dr Craig Innes |
| HVTN | Aurum | IAVI / B003: A Phase 1 Placebo-controlled, double-blind, randomized trial to evaluate the safety and immunogenicity of Ad26-ENVA and AD35-ENVA HIV vaccines in healthy HIV-uninfected adult volunteers | Dr Liesl Page-Shipp |
| HVTN | Aurum | AERAS-402: A Phase II double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of Aeras-402 in HIV-infected, BCG-vaccinated adults with CD4+ lymphocyte counts greater than 350 cells/mm³ | Prof Gavin Churchyard |