Av. Francisco Trein
596 - 4th Floor, Block A, Bairro Cristo Redentor
Porto Alegre, 91350-200
A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
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.
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).
A5388: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broadly neutralizing antibodies (bNAbs), when administered with ART, also have the potential to prevent the HIV virus from being able to reproduce.
This is a randomized, placebo-controlled research study that will enroll adults with recently diagnosed AHI. All participants will begin ART at entry and receive a single dose of two bNAbs (VRC07-523LS and PGT121.414.LS) or placebos. Everyone will be followed for about 1 year after starting ART, then stop ART for up to 2.5 years, then be followed for 1 year after restarting ART.
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.
A5403: Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
Transgender women (TW) are the fastest-growing group of people with HIV. Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medications in TW on Feminizing Hormone Therapy (FHT). This is an open-label, non-randomized trial of adult TW on three types of HIV medications who will receive estradiol for FHT for 48 weeks.
A5384: A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents with Tuberculous Meningitis
A5384 is a trial for people who have or might have tuberculous meningitis (TBM). TBM is an infectious disease that causes inflammation of the membranes that surround the brain and the spinal cord (meninges). TBM is caused by the bacterium Mycobacterium tuberculosis, which can be found elsewhere in the body, usually the lungs, but can travel via the bloodstream to the meninges, where the bacteria cause TBM.
This trial will compare a new experimental regimen of anti-TBM medicines taken over a 6-month time period with the current standard of care regimen of anti-TBM medicines taken over a 9-month time period.
A5354: Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Will evaluate whether starting antiretroviral drugs very early in HIV infection will limit the virus from getting into hidden areas of the body (reservoirs) and change how the immune system helps to control the virus.
This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.
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).
HIV comorbidities and complications
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
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.
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.
COVID-19 and Mpox