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DTHF CTU, Groote Schuur

More Info about DTHF CTU, Groote Schuur

Sponsor: Gilead Sciences, Inc.
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS–US-292-1515

A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed  Adolescents.

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Sponsor: Viiv Healthcare
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GSK-200304

A Phase 3b, randomised, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy

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Sponsor: Viiv Healthcare
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Recruiting

ING117175

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir or efavirenz each administered with two NRTIs in HIV-1-infected antiretroviral therapy-naïve adults starting treatment for rifampicin-sensitive tuberculosis

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Sponsor: National Institute of Health
DTHF PI: Prof LG Bekker
Site: Groote Schuur CTU
Status: Active - Not Recruiting

The Sibanye Health Project

Comprehensive HIV prevention package for MSM in Southern Africa: Pilot Study

The objective of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioural and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

Sponsor: HIV Prevention Trials Network
DTHF PI: Karen Dominguez
Site: Groote Schuur CTU
Status: Active - Not Recruiting

HVTN 075

Feasibility of HIV Prevention Cohort Studies among Men who have Sex with Men in Sub-Saharan Africa.

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

Sponsor: Merck Sharp & Dohme Corp
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

MK-1439-018

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA’ or EPZICOM /KIVEXA in Treatment-Naive HIV-1 Infected Subjects

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Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Groote Schuur CTU
Status: Active - Not Recruiting

HVTN CTAC

Establishing Immunologic Assays for Standardized Analyses of Clinical Specimens.

The aim of this study is to recruit individuals to provide blood, body fluids and mucosal specimens that will function as controls to standardize laboratory assays performed in HIV vaccine and other clinical trials.

Sponsor: Viiv Healthcare
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GSK-ING-117172

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

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Sponsor: Bristol-Myers Squibb
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

BMS-AI438-011

A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-label Period on the Recommended Dose

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Sponsor: University of Minnesota and the INSIGHT Network
DTHF PI: Prof Robin Wood
Site: Groote Schuur CTU
Status: Active - Not Recruiting

START

Strategic Timing of Antiretroviral Treatment (START)

The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality in HIV-1 infected persons who are antiretroviral naïve with a CD4+ count above 500 cells/mm3.

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Sponsor: Gilead Sciences, Inc.
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS-US-236-0112

A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

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Sponsor: Gilead Sciences, Inc.
DTHF PI: Assoc Prof Catherine Orrell
Site: Groote Schuur CTU
Status: Active - Not Recruiting

GS–US-292-0106

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents

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Sponsor: Microbicide Trials Network
DTHF PI: Prof Linda-Gail Bekker
Site: Groote Schuur CTU
Status: Completed

MTN-017

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

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Sponsor: Merck Sharp & Dohme Corp
DTHF PI: Dr Richard Kaplan
Site: Groote Schuur CTU
Status: Active - Not Recruiting

MK-0518-292

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects.

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Emavundleni Research Centre

More Info about Emavundleni Research Centre

Sponsor: MTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Recruiting

MTN 016

HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) study

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Sponsor: MERCK
DTHF PI: Dr Surita Roux
Site: Emavundleni
Status: Active - Not Recruiting

V503-010

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, administered in Preadolescents and Adolescents (9 to 14 year olds) with a Comparison to Young Women (16 to 26 year olds)

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Sponsor: MERCK
DTHF PI: Prof Linda-Gail Bekker
Site: Groote Schuur CTU
Status: Active - Not Recruiting

V503-002

Phase III Clinical Trial to Study the Immunogenicity, Tolerability,vand Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 year olds) with a Comparison to Young Women (16 to 26 year olds)

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Sponsor: MTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Recruiting

MTN 015

An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials

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Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Recruiting

HVTN 910

A protocol to assess the persistence of HIV vaccine-induced seropositivity in participants who received vaccine in DAIDS-funded preventive HIV vaccine trials

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Sponsor: MTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Active - Not Recruiting

MTN 020

A Multi-Center, 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

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Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Recruiting

HVTN 802

A descriptive and observational study of the effectiveness of potent antiretroviral therapy in HIV-1–infected persons who become HIV infected during the course of HIV-1 vaccine efficacy trials

Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Recruiting

HVTN 404

Long-term follow-up of HIV-1 infection in participants who become infected after enrollment in early-phase (phase 1 and 2a) HIV vaccine protocols or HIV vaccine preparedness cohorts

Sponsor: HVTN
DTHF PI: Prof Linda-Gail Bekker
Site: Emavundleni
Status: Active - Not Recruiting

HVTN 097

A phase 1b randomized double blind placebo controlled clinical trial to evaluate the safety and immunogenicity of the vaccine regimen ALVAC-HIV (vCP1521) followed by AIDSVAX® B/E in healthy, HIV-1 uninfected adult participants in South Africa

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Masiphumelele Research Sites

More Info about Masiphumelele Research Sites

Sponsor: South African Medical Research Council
DTHF PI: Prof Robin Wood
Site: Desmond and Leah Tutu Research Centre
Status: Recruiting

CO2 monitoring studies

Current research efforts include investigating where TB transmission may occur to adolescents and adults.  In collaboration with the UCT Department of Electrical Engineering we have developed an innovative approach to the study of TB transmission: using measurements of individual-based environmental CO2 monitoring to determine rebreathed litres of air as a surrogate measure of risk of TB infection. Prof Wood is currently leading studies to identify community locations of potential TB transmission risk among adolescents and adults, utilizing these C02 measurements.

Sponsor: DTHF, Royal Society, Bill and Melinda Gates Foundation
DTHF PI: Dr Keren Middelkoop
Site: Desmond and Leah Tutu Research Centre
Status: Recruiting

TB Molecular epidemiological study

Observational studies in which all TB patients are invited to participated. The study uses a combination of notification data, patient interviews, and genotyping of the TB bacterium to investigate the ongoing, longterm impact of the ART program on TB rates and to continue to explore TB strain diversity and transmission in this community, including the changes through time in the clustering and transmission of TB disease among HIV-positive and HIV-negative individuals

Sponsor: DTHF, Royal Society, Bill and Melinda Gates Foundation
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Not Yet Recruiting

Cardiovascular Disease Risk Factors in ART-experienced Cohort

An observational study assessing the frequency and severity of six CVD risk factors in an established, prospective cohort of ART-experienced HIV-infected patients.

Sponsor: South African Medical Research Council, Bill and Melinda Gates Foundation
DTHF PI: Prof Robin Wood
Site: The Masiphumelele Research Offices
Status: Not Yet Recruiting

Controlled Collection of Aerosolized Mycobacterium Particles

The purpose of this Research Study is to investigate airborne aerosolized Mycobacterium particles expelled by infectious TB patients. It aims to understand how these TB particles differ when being collected by means of air versus collected by means of culture and to explore TB organism adaption to particle size and environmental stress. The research team also hopes to also characterise the nature of the TB organism and thus identify specific points that can be exploited to interrupt and reduce the spread of TB.

Sponsor: IPM
DTHF PI: Dr Katherine Gill
Site: Desmond and Leah Tutu Research Centre
Status: Recruiting

IPM 027

A Multi-Center, 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

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Sponsor: CONRAD
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Active - Not Recruiting

FACTS001

Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of Tenofivir Vaginal Gel for the Prevention of HIV-1 Infection in Women

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Gugulethu Research Sites

More Info about Gugulethu Research Sites

Sponsor: NIH
DTHF PI: Prof Landon Myer
Site: Gugulethu MOU
Status: Active

The Prematurity Immunology in HIV-infected Mothers and their infants Study (PIMS) (2015-2018)

A prospective cohort study following women on ART during pregnancy to examine the association of ART with prematurity and the mechanisms that may be involved in any such association.

Sponsor: NIH
DTHF PI: Prof Landon Myer
Site: Gugulethu MOU
Status: Active

The Two-IUD (‘2IUD’) study (2013-2017)

A randomised controlled trial comparing the effect of two intrauterine devices (IUD) in HIV–infected women.

Sponsor: NIH
DTHF PI: Prof Landon Myer
Site: Hannan Crusaid Treatment Centre
Status: Active

Postpartum Adherence Clubs to Enhance Retention (PACER) (2015-2016

A substudy of MCH-ART examining the feasibility and acceptability of the ‘adherence club’ model of care for women on ART during the postpartum period.

Sponsor: NIH
DTHF PI: Prof Landon Myer
Site: Gugulethu MOU
Status: Active

Maternal and Child Health – Antiretroviral Therapy (MCH-ART)

This  multicomponent implementation science study (2013-2016) is examining the delivery of antiretroviral therapy during pregnancy and the postpartum period, including the role of health service integration in improving outcomes for HIV-infected mothers and HIV-exposed infants during the postpartum period.

Sponsor: EGPAF
DTHF PI: Prof Landon Myer
Site: Gugulethu MOU
Status: Completed

Strategies for the Rapid Initiation of Antiretroviral Therapy in Pregnancy (2011-2014).

This operations research study examined the implementation and effect of various service delivery models to improve ART initiation, including point-of-care CD4 testing and service integration.

Sponsor: NIH
DTHF PI: Professor Linda-Gail Bekker
Site: Hannan Crusaid Treatment Centre
Status: Recruiting

The Cape Town Adolescent AIDS Cohort study (CTAAC)

The Cape Town Adolescent AIDS Cohort study (CTAAC), led by Heather Zar in collaboration with a multidisciplinary primarily UCT-based team aims to investigate markers of chronic disease processes and progression in perinatally HIV-infected SA adolescents in four key areas (general adolescent development; neurocognitive function; pulmonary disease; cardiovascular function). This is a prospective, descriptive cohort study of 520 HIV+ve
adolescents on ART, aged 9 to 14 years, followed for 3 years.

Sponsor: EDCTP
DTHF PI: Assoc. Prof Catherine Orrell
Site: Hannan Crusaid Treatment Centre
Status: Completed

The TAP study

A randomised controlled Trial to explore Adherence-failure relationships in a South African antiretroviral delivery site, using an electronic adherence device and sparse Pharmacokinetic sampling (2012-2014): This randomised study on adherence was completed in 2014. 230 people were enrolled 1:1 to either receive a text message reminder, sent only when dosing was late, and recorded by real-time electronic adherence monitoring device (Wisepill®), or to standard of care. The aim was to examine whether this would improve adherence and HIV viral suppression over 48 weeks. Text messages did reduce the number of prolonged treatment interruptions, but did not significantly improve overall adherence or HIV viral suppression. Pharmacokinetic and pharmacogenetic data are pending.

Sponsor: Bill and Melinda Gates Foundation
DTHF PI: Assoc. Prof Catherine Orrell
Site: Hannan Crusaid Treatment Centre
Status: Not Yet Recruiting

META study

Measuring Early Treatment Adherence: implications for an AIDS-free generation. A cohort study to examine adherence and retention in care of those ill with HIV (CD4<200) compared to those who are starting ART when still well (CD4>350).

Sponsor: NIH
DTHF PI: Assoc. Prof Catherine Orrell
Site: Hannan Crusaid Treatment Centre
Status: Recruiting

ART Refusal Study

Examining the Correlates and Outcomes of HIV Treatment Refusal in an Adult South Africa Cohort. A study to determine the characteristics of individuals who refuse to start ART.

Desmond Tutu Youth Centre

More Info about Desmond Tutu Youth Centre

Sponsor: Desmond Tutu HIV Foundation, NIAID, NIH
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Active - Not Recruiting

HPV-GEN

HPV Genotyping. This observational study aims to assess differences in HPV types and persistence in 50 HIV-positive and 50 HIV-negative adolescent females in Cape Town, South Africa

Sponsor: UCT
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Recruiting

WISH

This is a basic science mucosal study examining factors affecting HIV susceptibility in the adolescent genital tract.

Sponsor: DTHF, Division of AIDS, NIAID, US National Institute of Child Health and Human Development, US National Institutes of Health
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Not Yet Recruiting

CHAMPS-UChoose

Choices for Adolescent Methods of Prevention in South Africa. This is An Open-Label, Randomized Crossover Study to Evaluate the Acceptability and Preference for Contraceptive Options in Healthy HIV-Uninfected Female Adolescents, 16-17 Years of Age, as proxy for HIV prevention methods

Sponsor: Desmond Tutu HIV Foundation, UCT, DAIDS/NIAID/NIH
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Active - Not Recruiting

CHAMPS-MACHO

Choices for Adolescent Methods of Prevention in South Africa: This is an acceptability study to investigate the preferences for and attitudes towards circumcision in healthy, HIV-uninfected adolescent males, 14-17 years of age.

Sponsor: DAIDS/NIAID/NIH
DTHF PI: Prof Linda-Gail Bekker
Site: Desmond and Leah Tutu Research Centre
Status: Recruiting

CHAMPS-PlusPills

Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: ‘PlusPills’ A Demonstration Open Label Study to Assess the Acceptability and Use of Truvada Pre-exposure Prophylaxis in Healthy, HIV-Uninfected Adolescents, 15-19 Years of Age.

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