A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE) A5361s: Substudy of REPRIEVE (A5332) Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

Study Location:

Baltimore

Topic:

HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/record/NCT03070223?term=Pitavastatin+to+REduce+Physical+Function+Impairment+and+FRailty+in+HIV+%28PREPARE%29&rank=1

IRB#:

IRB00126115

Coordinator:

Ilene Wiggins

Enrollment:

Open

Trial Period:

Ongoing

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.

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

Ilene Wiggins: iwiggin1@jhmi.edu

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