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Home / CTU Studies

CTU Studies

NETWORK

CLINICAL RESEARCH SITE

TITLE

SITE PRINCIPAL
INVESTIGATOR/S

ONGOING

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

COMPLETED

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 

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

IMPAACT

Umlazi

IMPAACT 1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) 

Dr Daya Moodley

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 Sub-study: ARV Adherence and Exposure – Hair sub-study

Dr Daya Moodley

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

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

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

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

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

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

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

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

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

 

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