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PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)

NCT03070223 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2024-10-28

Study results available
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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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Pitavastatin

One tablet (4 mg) taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.

DRUG

Placebos

One tablet taken once daily, orally with or without food for the entire time participant was in REPRIEVE follow-up.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Todd Brown, MD, PhD · Johns Hopkins University

  • Kristine Erlandson, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2023-08-21
Completion
2023-08-21
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070223 on ClinicalTrials.gov