Rustenburg CRS

The standard of care (SOC) treatment of tuberculosis (TB) was developed over 40 years ago, and the treatment is long (6 months) and hard. In many settings, the medicine does not work well because people stop taking it or miss doses, which leads to TB returning. For some people, the SOC treatment can cause negative side effects.

This study will evaluate new medication regimens for the treatment of TB. This study is adaptive, which means, as new medication regimens are identified for the treatment of TB, some of them will be selected for testing in this study. Therefore, there may be different drug regimens being used as part of the study at different times.

Treatment Naïve

A5417: Randomized, Double-Blind, Placebo-Controlled Study of the Combination of two Long-Acting Broadly Neutralizing Antibodies at ART Initiation in Adults Living with HIV-1 in sub-Saharan Africa

This study enrolls people living with HIV in sub-Saharan Africa at the time that they are about to start antiretroviral therapy (ART). They will be assigned to receive either two long-acting study medications called “monoclonal antibodies” or placebo (normal saline) when they start ART. An antibody is a substance that the body makes in response to an infection. The antibodies in this study attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These study antibodies are being developed to potentially treat and prevent HIV.

Tuberculosis

Active, Not Recruiting

A5397/HVTN 603:A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB

Effective tuberculosis (TB) treatment is available and saves millions of lives, but it has not had a significant impact on the global TB epidemic. The treatment requires strict adherence to taking the medicine on schedule, and if it isn’t taken as directed people can relapse before they complete treatment. TB can recur in up to 8% of people who successfully complete TB treatment. Having an effective TB vaccine to prevent TB infection and control TB disease is essential to eliminate TB globally.

A5397/HVTN 603 will give participants 2 injections of a study vaccine called ID93+GLA-SE or a placebo at different times after they have started taking TB treatment. The researchers will compare responses in people who get the study vaccine to people who get the placebo. This study will enroll both people with and without HIV. It is the first to test ID93 + GLA-SE in people living with HIV (PLWH).

Treatment Experienced

A5385: An Observational Post-Intervention Cohort Destination Protocol

This study is a two-step, non-interventional extension study for individuals participating in another interventional HIV cure trial (parent study) that includes an analytical treatment interruption (ATI) (stopping anti-HIV therapy [ART] while monitoring viral load). Participants will be individuals who achieved post-intervention control (PIC) (maintaining HIV suppression after treatment interruption) in their parent study.

Step 1 will consist of an extended ATI period in which PICs will be monitored for safety, viral, and immune outcomes. Time to viral rebound and restart of antiretroviral therapy (ART) will be measured. Participants will begin Step 2 if they meet ART restart criteria and will be monitored for safety, immune, and viral outcomes through 48 weeks after ART restart.

HIV Cure

Treatment Experienced

A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study

AHRC (pronounced “ARC”) is a study of differences and changes over time in HIV reservoirs (groups of HIV-infected cells that “hide” from anti-HIV medications). This study enrolls people into one of six groups, based on their different HIV treatment histories. The current version of this study is only enrolling for Group 6, which will include people who acquired or are suspected to have acquired HIV while taking long-acting cabotegravir (LA CAB) for pre-exposure prophylaxis (PrEP).

Tuberculosis

Closed to accrual

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)

This trial is in household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for TB. HHC means any person that lives with, has lived with, or shared housekeeping duties in a home or the same place with a person (an Index Case) who has pulmonary MDR-TB (a lung infection or pneumonia with TB) and started treatment for MDR-TB within the past 90 days. It is also for people who have spent more than 4 hours indoors with the index case, during the week before they started MDR-TB treatment.

High-risk household contacts are those with HIV or an immune system problem not from HIV like cancer , latent TB infection (a history of TB infection in the past based on testing), and young children below the age of 5 years.