A5361s: PREPARE Substudy of REPRIEVE (A5332)

Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

Study Description

PREPARE is an observational study of muscle strength and function among HIV-infected adults who are receiving pitavastatin or placebo as part of the REPRIEVE study (A5332) and are also enrolled in the Mechanistic substudy (A5333s).

Why is this study being done?

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. The main purpose of this study is to see if pitavastatin can slow or prevent the decline in physical function of adults aging with HIV infection.

Who can join? 

HIV infected men and women between the ages of 40 and 75 • Co-enrolled in REPRIEVE and the Mechanistic (CT) substudy • Taking pitavastatin or placebo as part of REPRIEVE What do I need to do in the study? Muscle strength and muscle function will be measured at yearly visits. Tests will include repeated chair rises, hand grip strength test, standing balance test and a 12 foot (4 meter) walk. Participants will also be asked questions about their physical activity. No additional CT scans or blood will be collected. Participants will be followed for 48 months from the date of enrollment into REPRIEVE. 

What treatments or drugs are involved with this study?

The study treatments, pitavastatin or placebo, will be provided through the REPRIEVE main study.

Study Status: