Site Details
Site Type
CRS
Site Trials
HIV Cure
A5341s: Intensive Reservoir Sampling, A5321 Substudy
Longitudinal Sampling Substudy of A5321 is collecting information from measures of different HIV reservoirs, including where HIV can be found, whether different reservoirs have different amounts of HIV, the best way is to measure the amount of HIV in different reservoirs, and whether the amount of HIV found in one reservoir says anything about the amount of HIV in other reservoirs.
See More Info on A5321 to learn more.
HIV Cure
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.
HIV Cure
HIV (and comorbidities)
HIV (and comorbidities)
A5357: A Study of Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) to Maintain Viral Suppression in Adults Living with HIV-1
This study is for people with HIV who have an undetectable viral load. The study will evaluate the safety and effectiveness of a combination of two medications. The first drug is called long-acting cabotegravir (CAB), which will be given orally during Part 1 of the study and then as an injection every 4 weeks during Part 2 of the study. The second drug is called VRC07-523LS, which is a monoclonal antibody. A monoclonal antibody targets human proteins rather than attacking the virus directly. This drug will be given intravenously (directly into a vein) over about 15 to 30 minutes every 8 weeks.
HIV (and comorbidities)
A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation (HAILO)
You are being asked to take part in this research study because you are infected with HIV, the virus that causes AIDS, and were previously followed in the ALLRT (A5001) study and are 40 years of age or older. This study, A5322 (also known as the HAILO study), is a long-term follow-up study of persons who have HIV and received their first treatment for HIV known as antiretroviral medications, in certain clinical trials that were done by the AIDS Clinical Trials Group (ACTG).
HIV (and comorbidities)
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 (and comorbidities)
A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)
Aging with HIV may be associated with an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins, such as pitavastatin, might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle, or by decreasing inflammation markers in the blood. This study uses the REPRIEVE Trial (A5332) and the REPRIEVE Mechanistic Substudy (A5333s) to study the impact of pitavastatin on muscle.
Hepatitis
COVID-19
A5401: ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies
A master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.
HIV (and comorbidities)
A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease. NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack). In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism. Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.
Hepatitis
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
A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Vaccine
Right now there is no medicine proven to treat COVID-19 in people who are not sick enough to be hospitalized. Researchers will be testing different investigational medicines that they believe are most likely to help people with COVID-19.
They want to see if these investigational medicines:
- Are safe for those who need them
- Can help people get better faster
- Can get rid of the virus
- Can help keep oxygen levels up
- Can keep people from getting sicker
- Can prevent people from having to go to the hospital
The whole study lasts about 6 months (24 weeks).
During the study you would have in-person visits with tests to check on your health. Most of these visits happen during the first month of the study.
You would also have phone calls or videos chats with the researcher from your home.
The study team will give you a diary to keep track of your temperature each evening and any symptoms you have. You’ll be asked to fill out this diary for the first 28 days.
If the study is right for you, you will have your first visit, or entry visit, to meet with a researcher for tests and to be placed in a treatment group.
Each study medicine will be compared to a placebo. A placebo looks like the real drug but doesn’t have any actual medicine in it. This gives researchers something to compare the study medicine to. You would not know if you are receiving the study medicine or placebo until the end of the study. If a standard treatment for COVID-19 is found during the study, that treatment will be used instead of placebo. Different medicines may be tested during the study at the same time. One type of investigational medicine you might receive is called a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the lab and help your body attack invaders, such as viruses, to keep them from entering your cells. Once you are placed in a treatment group, you will receive more information on that investigational medicine being tested, including any possible side effects.
To learn more about this study click here.
Mpox