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

Status: Completed
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Alabama CRS (31788)
Birmingham
California
University of California, Los Angeles CARE Center CRS (601)
Los Angeles
University of Southern California (1201)
Los Angeles
Ucsd, Avrc Crs (701)
San Diego
Ucsf Aids Crs (801)
San Francisco
Harbor-UCLA Med. Ctr. CRS (603)
Torrance
Colorado
University of Colorado Hospital CRS (6101)
Aurora
Illinois
2701 Northwestern University CRS
Chicago
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago
Massachusetts
Brigham and Women's Hosp. ACTG CRS (107)
Boston
Massachusetts General Hospital (MGH) CRS (101)
Boston
Maryland
Johns Hopkins University CRS (201)
Baltimore
Missouri
Washington University CRS (2101)
Saint Louis
North Carolina
Unc Aids Crs (3201)
Chapel Hill
Greensboro CRS (3203)
Greensboro
New Jersey
New Jersey Medical School Clinical Research Center CRS (31786)
Newark
New York
Columbia Physicians and Surgeons CRS (30329)
New York
Weill Cornell Chelsea CRS (7804)
New York
Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803)
New York
University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
Rochester
Ohio
Univ. of Cincinnati CRS (2401)
Cincinnati
Case CRS (2501)
Cleveland
The Ohio State Univ. AIDS CRS (2301)
Columbus
Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia
Pittsburgh CRS (1001)
Pittsburgh
Rhode Island
The Miriam Hospital (TMH) ACTG CRS (2951)
Providence
Tennessee
Vanderbilt Therapeutics CRS (3652)
Nashville
Texas
Trinity Health and Wellness Center CRS (31443)
Dallas
Houston AIDS Research Team (HART) CRS (31473)
Houston
Washington
University of Washington AIDS CRS (1401)
Seattle
Other Locations
Puerto Rico
Puerto Rico-AIDS CRS (5401)
San Juan
Time Frame
Start Date: 2017-03-14
Completion Date: 2023-08-21
Participants
Target number of participants: 602
Treatments
Experimental: Pitavastatin
Participants who were randomized to pitavastatin in the main study REPRIEVE.
Placebo_comparator: Placebo
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA)
Leads: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

This content was sourced from clinicaltrials.gov