Site Details
Site Type
CRS
Site Trials
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 comorbidities and complications
Closed to accrual
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.
COVID-19 and Mpox
Closed to accrual
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.
COVID-19 and Mpox
Closed to accrual
A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Subsequent 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.
COVID-19 and Mpox