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Summary

for people ages 40–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Aging with HIV may be related to 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 (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 substudy is being done to determine the impact of the drug pitavastatin on muscle.

Official Title

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

Details

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study.

Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function, frailty and self-reported physical activity and sedentary time. In addition, demographic and clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE (A5332) or its mechanistic sub-study A5333s will be used.

Keywords

HIV-1 Infection Pitavastatin

Eligibility

You can join if…

Open to people ages 40–75

  • 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 CAN'T join if...

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

Locations

  • Ucsf Aids Crs (801) accepting new patients
    San Francisco, California, 94110, United States
  • 601 University of California, Los Angeles CARE Center CRS accepting new patients
    Los Angeles, California, 90035, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Clinical Trials Group
ID
NCT03070223
Lead Scientist
Diane V. Havlir
Study Type
Observational
Last Updated
May 1, 2017
I’m interested in this study!