Family Clinical Research Unit (FAM-CRU) CRS

Site Details

LOCATION

Tygerberg Hospital

Tygerberg, Western Cape, 7505

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Site Type

CRS

CRS Coordinator

Joan Coetzee

joan@sun.ac.za

27-21-9384157

CRS Leader

Mark Cotton

mcot@sun.ac.za

27-21-9384219

Site Trials

Hepatitis

HIV comorbidities and complications

HIV Cure

HIV Treatment

Tuberculosis

Closed to accrual

A5243: Non-US Genomic Sampling

Collecting blood and saliva samples from former and current ACTG study participants for future HIV-related genetic testing.

This is a study to collect blood and saliva samples from former and current participants in AIDS Clinical Trial Group (ACTG) studies at non-U.S. sites.

HIV comorbidities and complications

Closed to accrual

A5332: REPRIEVE Trial

In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.

HIV Treatment

Closed to accrual

A5381: Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART

This is a study for people who have HIV and qualify to switch to or receive Dolutegravir containing antiretroviral therapy (ART, group of medicine used to treat HIV). Taking TLD (combination pill of three medicines for HIV, tenofovir-lamivudine-dolutegravir) has shown to be better tolerated, work better against the virus known as virologic efficacy, have fewer drug-drug interactions, and have less frequent onset of HIV drug resistance than Efavirenz containing ART. In August 2017, a decision was made to start using TLD for first- and second-line ART in many places in the world. This study is designed to help us understand the risks and benefits of TLD roll-out in low- and middle-income countries that may not use viral load testing and HIV resistance testing (a way to measure if a drug will work against your HIV) to guide ART management.  Each participant will be assigned to one of four groups:

  • Group 1: Participants switching to TLD, after taking prior anti-HIV medication that contains a NNRTI drug (a group of medicines scientifically known as non-nucleoside reverse transcriptase inhibitors, such as Efavirenz or Nevirapine).
  • Group 2: Participants switching to TLD, after taking anti-HIV medication that contains a PI drug (a group of medicines scientifically known as protease inhibitors, such as Lopinavir or Atazanavir).
  • Group 3: Participants taking TLD and receiving medication for TB (tuberculosis) that includes the drug rifampicin. These participants must be starting one or both of these medications when they enter the study.
  • Group 4: Participants starting TLD who have not taken anti-HIV medication before.

There will be 1350 participants enrolled in the study.

Hepatitis

Closed to accrual

A5379: B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): Evaluation of HEPLISAV-B

A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.