Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
602 participants
INTERVENTIONAL
2017-03-14
2023-08-21
Brief Summary
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Detailed Description
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1. enrolled in both REPRIEVE and its Mechanistic Substudy (A5333s, subsequently referred to as Mechanistic Substudy) within 24 of their REPRIEVE enrollment
2. enrolled in REPRIEVE alone concurrently with their REPRIEVE enrollment.
The target sample size was 600 participants. The study was conducted at the REPRIEVE U.S. sites participating in the Mechanistic Substudy, and enrollment from the Mechanistic Substudy was prioritized to maximize the number of participants with computed tomography (CT) scan data performed as part of the Mechanistic Substudy.
Treatment groups (pitavastatin vs placebo) were defined according to randomization in REPRIEVE. Participants were enrolled into PREPARE blinded to their REPRIEVE treatment allocation. No intervention was provided in this ancillary study.
Originally the study duration was 48 months after participants' REPRIEVE entry. An additional visit was added at Month 60 due to missed in-person evaluations during the COVID-19 related restrictions in 2020 through early 2021.
Study visits were scheduled at PREPARE entry and at months 12, 24, 36, 48 and 60 after REPRIEVE entry. Each study visit included 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 or its Mechanistic Substudy were used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Pitavastatin
Participants who were randomized to pitavastatin in the main study REPRIEVE.
Pitavastatin
One tablet (4 mg) taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.
Placebo
Participants who were randomized to placebo for pitavastatin in the main study REPRIEVE.
Placebos
One tablet taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.
Interventions
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Pitavastatin
One tablet (4 mg) taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.
Placebos
One tablet taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute on Aging (NIA)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Todd Brown, MD, PhD
Role: STUDY_CHAIR
Johns Hopkins University
Kristine Erlandson, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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Alabama CRS (31788)
Birmingham, Alabama, United States
University of Southern California (1201)
Los Angeles, California, United States
University of California, Los Angeles CARE Center CRS (601)
Los Angeles, California, United States
Ucsd, Avrc Crs (701)
San Diego, California, United States
Ucsf Aids Crs (801)
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
2701 Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS (2702)
Chicago, Illinois, United States
Johns Hopkins University CRS (201)
Baltimore, Maryland, United States
Massachusetts General Hospital (MGH) CRS (101)
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, United States
Washington University CRS (2101)
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS (31786)
Newark, New Jersey, United States
Weill Cornell Chelsea CRS (7804)
New York, New York, United States
Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803)
New York, New York, United States
Columbia Physicians and Surgeons CRS (30329)
New York, New York, United States
University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787)
Rochester, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
Greensboro CRS (3203)
Greensboro, North Carolina, United States
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, United States
Case CRS (2501)
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS (2301)
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, United States
Pittsburgh CRS (1001)
Pittsburgh, Pennsylvania, United States
The Miriam Hospital (TMH) ACTG CRS (2951)
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS (3652)
Nashville, Tennessee, United States
Trinity Health and Wellness Center CRS (31443)
Dallas, Texas, United States
Houston AIDS Research Team (HART) CRS (31473)
Houston, Texas, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, United States
Puerto Rico-AIDS CRS (5401)
San Juan, PR, Puerto Rico
Countries
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References
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Erlandson KM, Umbleja T, Lu MT, Taron J, Ribaudo HJ, Overton ET, Presti RM, Haas DW, Sax PE, Yin MT, Zhai BK, Louis R, Upadhyay N, Eslami P, Douglas PS, Zanni MV, Fitch KV, Fulda ES, Fichtenbaum CJ, Malvestutto CD, Grinspoon SK, Brown TT. Associations of Muscle Density and Area With Coronary Artery Plaque and Physical Function. J Acquir Immune Defic Syndr. 2023 Oct 1;94(2):174-184. doi: 10.1097/QAI.0000000000003244.
Abidi MZ, Umbleja T, Overton ET, Burdo T, Flynn JM, Lu MT, Taron J, Schnittman SR, Fitch KV, Zanni MV, Fichtenbaum CJ, Malvestutto C, Aberg JA, Fulda ES, Eckard AR, Manne-Goehler J, Tuan JJ, Ribaudo HJ, Douglas PS, Grinspoon SK, Brown TT, Erlandson KM. Cytomegalovirus IgG is Associated With Physical Function But Not Muscle Density in People With HIV. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):470-478. doi: 10.1097/QAI.0000000000003377.
Umbleja T, Brown TT, Overton ET, Ribaudo HJ, Schrack JA, Fitch KV, Douglas PS, Grinspoon SK, Henn S, Arduino RC, Rodriguez B, Benson CA, Erlandson KM. Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE. J Infect Dis. 2020 Jul 9;222(Suppl 1):S52-S62. doi: 10.1093/infdis/jiaa249.
Erlandson KM, Umbleja T, Ribaudo HJ, Schrack JA, Overton ET, Fichtenbaum CJ, Fitch KV, Roa JC, Diggs MR, Wood K, Zanni MV, Bloomfield GS, Malvestutto C, Aberg JA, Rodriguez-Barradas MC, Morones RG, Breaux K, Douglas PS, Grinspoon SK, Brown TT. Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function. Clin Infect Dis. 2025 Feb 24;80(2):425-433. doi: 10.1093/cid/ciae422.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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