CTU Studies
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NETWORK |
CLINICAL RESEARCH SITE |
TITLE |
SITE PRINCIPAL |
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ONGOING |
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| ACTG | Springfield | A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study | Prof Kogieleum Naidoo |
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HVTN |
eThekwini |
HVTN 705: A multicenter, randomized, double-blind, placebo-controlled phase 2b efficacy study of a heterologous prime/boost vaccine regimen of Ad26.Mos4.HIV and aluminium phosphate-adjuvanted Clade C gp140 in preventing HIV-1 infection in women in sub-Saharan Africa |
Dr Nigel Garrett |
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HVTN |
eThekwini |
HVTN 107: A Phase 1 double-blind, randomized clinical trial to characterize the safety and immunogenicity of clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120 alone, with MF59® adjuvant, and with alum adjuvant in healthy, HIV uninfected adult participants. |
Dr Nivashnee Naicker |
| HVTN | eThekwini | HVTN 805: Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081 | Dr Nigel Garrett / Dr Halima Dawood |
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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 Nigel Garrett |
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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 Nigel Garrett |
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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 Nivashnee Naicker |
| HVTN | eThekwini / Vulindlela | HVTN 805: Antiretroviral analytical treatment interruption (ATI) to assess immunologic and virologic responses in participants who initiated ART in early HIV infection after having received VRC01 or placebo in HVTN 703/HPTN 081 | Dr Nigel Garrett / Dr Halima Dawood |
| HPTN | Isipingo | HPTN 084: 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 | Dr Dishiki Kalonji / Dr Elizabeth Spooner |
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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 |
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HPTN |
Vulindlela |
HPTN 081: A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection |
Prof Quarraisha Abdool Karim/ Site PI: Dr Halima Dawood |
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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 |
Prof Daya Moodley |
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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 |
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IMPAACT |
Umlazi |
IMPAACT 2028 (A Roll-Over Study from P1115) Long-Term Clinical, Immunologic, and Virologic Profiles of Children who Received Early Treatment for HIV |
Dr Kimesh Naidoo/ Prof Daya Moodley |
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IMPAACT |
Umlazi |
IMPAACT 2017: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents |
Dr Sherika Hanley/ Prof Daya Moodley |
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IMPAACT |
Umlazi |
IMPAACT 2019: Phase I/II study of the pharmacokinetics, safety and tolerability of abacavir / dolutegravir / lamivudine dispersible and immediate release tables in HIV infected children less that 12 years of age |
Dr Kimesh Naidoo/ Prof Daya Moodley |
| IMPAACT | Umlazi | IMPAACT 2023 - A phase I study of the Safety and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 | Prof Daya Moodley |
| IMPAACT | Umlazi | IMPAACT 2035/HVTN 604 Phase I/II Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination against Tuberculosis in Pre-Adolescents Living with and without HIV in South Africa | Prof Daya Moodley |
| PROMOTE | Umlazi | PROMOTE:(Extension of PROMISE Study) Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes | Dr Sherika Hanley/ Prof Daya Moodley |
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COMPLETED |
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MTN |
eThekwini |
MTN 015: An Observational Cohort Study of Women following HIV-1 seroconversion in Microbicide Trials. |
Dr Leila Mansoor |
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MTN |
eThekwini |
MTN 016: HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study. |
Dr Leila Mansoor |
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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 |
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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 |
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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 |
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IMPAACT |
Umlazi |
IMPAACT 1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) |
Dr Daya Moodley |
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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 |
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IMPAACT |
Umlazi |
IMPAACT 1077BF Sub-study: ARV Adherence and Exposure – Hair sub-study |
Dr Daya Moodley |
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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 |
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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 |
| IMPAACT | Umlazi | IMPAACT 2008: Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infant | Dr Moherndran Archary |
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IMPAACT |
Umlazi |
IMPAACT P1084s: Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health. |
Dr Daya Moodley |
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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 |
| 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 |
| IMPAACT | Umlazi | 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 | Dr Sherika Hanley |
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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 Nigel Garrett |
| HVTN | eThekwini | HVTN 107: A Phase 1 double-blind, randomized clinical trial to characterize the safety and immunogenicity of clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120 alone, with MF59® adjuvant, and with alum adjuvant in healthy, HIV uninfected adult participants. | Dr Nivashnee Naicker |
| 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 | Dr Nigel Garrett |
|
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/ Vulindlela | AMP: 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 in women in sub-Saharan Africa | Dr Nigel Garrett / Dr Halima Dawood |
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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 InnesH |
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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 |
| HTPN | 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 |
| HTPN | Vulindlela | HPTN 081: A phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV | Prof Quarraisha Abdool Karim/ Site PI: Dr Halima Dawood |
| HTPN | Vulindlela | HPTN 1901: Characterizing SARS-CoV- 2-specific immunity in convalescent individuals | Prof Quarraisha Abdool Karim |
| HTPN | Umlazi | HPTN 046: Phase III Trial to Determine the Efficacy and 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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AACTG |
eThekwini |
AACTG A5253: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals |
Dr Nesri Padayatchi |
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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 |
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AACTG |
eThekwini |
AACTG A5274: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens |
Dr Nesri Padayatchi |
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AACTG |
eThekwini |
AACTG A5304: Controlled comparison of two moxifloxacin containing treatment shortening regimens with the standard regimen in pulmonary tuberculosis |
Dr Nesri Padayatchi |