PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

Aging with HIV is associated with earlier development of frailty (weakness) or disability, including loss of physical and muscle strength, and 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 (for example, pitavastatin) might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle or by decreasing inflammation markers (substances in the blood that determine how the body reacts to infection or irritation) in the blood. Other studies have shown that statins increase the risk of muscle aches and pains. This ancillary study was done to determine the impact of the drug pitavastatin on physical and muscle function.

Key facts

Study ID

NCT03070223

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

602

Starts

2017-03-14

Expected to finish

2023-08-21

Last updated by the study team

2024-10-28

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ambulatory participants enrolled in both REPRIEVE (A5332) and its Mechanistic Substudy (A5333s) or ambulatory participants who are newly enrolling into REPRIEVE (A5332) at A5333s ACTG sites.

You may not qualify if…

• Inability to ambulate independently (use of a cane or a walker is permitted) or rise from a chair without assistance.

Where it is running

• Alabama CRS (31788) — Birmingham, Alabama, United States
• University of Southern California (1201) — Los Angeles, California, United States
• University of California, Los Angeles CARE Center CRS (601) — Los Angeles, California, United States
• Ucsd, Avrc Crs (701) — San Diego, California, United States
• Ucsf Aids Crs (801) — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS (603) — Torrance, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• 2701 Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago, Illinois, United States
• Johns Hopkins University CRS (201) — Baltimore, Maryland, United States
• Massachusetts General Hospital (MGH) CRS (101) — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States
• Washington University CRS (2101) — St Louis, Missouri, United States
• New Jersey Medical School Clinical Research Center CRS (31786) — Newark, New Jersey, United States
• Weill Cornell Chelsea CRS (7804) — New York, New York, United States
• Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803) — New York, New York, United States
• Columbia Physicians and Surgeons CRS (30329) — New York, New York, United States
• University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) — Rochester, New York, United States
• Unc Aids Crs (3201) — Chapel Hill, North Carolina, United States
• Greensboro CRS (3203) — Greensboro, North Carolina, United States
• Univ. of Cincinnati CRS (2401) — Cincinnati, Ohio, United States
• Case CRS (2501) — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS (2301) — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS (6201) — Philadelphia, Pennsylvania, United States
• Pittsburgh CRS (1001) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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