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Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

NCT02344290 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7769

Last updated 2025-09-04

Study results available
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Summary

People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).

The REPRIEVE trial consisted of two parallel identical protocols:

* REPRIEVE (A5332) was funded by the NHLBI, with additional infrastructure support provided by the NIAID, and was conducted in U.S and select international sites (approximately 120 sites in 11 countries).
* REPRIEVE (EU5332) was co-sponsored by NEAT ID and MGH, and was conducted at 13 sites in Spain.

Conditions

Interventions

DRUG

Pitavastatin

One tablet (4 mg) taken once daily, orally with or without food

DRUG

Placebo

One tablet taken once daily, orally with or without food

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Kowa Pharmaceuticals America, Inc.

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Massachusetts General Hospital

    collaborator OTHER

  • NEAT ID Foundation

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Steven Grinspoon, MD · Harvard Medical School (HMS and HSDM)

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
2015-03-26
Primary Completion
2023-08-21
Completion
2023-08-21

Countries

  • United States
  • Botswana
  • Brazil
  • Canada
  • Haiti
  • India
  • Peru
  • Puerto Rico
  • South Africa
  • Spain
  • Thailand
  • Uganda
  • Zimbabwe

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02344290 on ClinicalTrials.gov