PREPARE (A5361s) Substudy of REPRIEVE (A5332)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- HIV -1 Infection
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 40 years and 75 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03070223
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute on Aging (NIA)
- Investigators
- Study Chair: Todd Brown, MD, PhD Johns Hopkins University Study Chair: Kristine Erlandson, MD University of Colorado, Denver
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