CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 602 enrolled
Drug / intervention
Pitavastatin +1 moredrug
Likely dose
Pitavastatin 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03070223
NCT03070223Phase 3Completed

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

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Mar 3, 2017·Updated Oct 28, 2024

In Brief

A Phase 3 clinical trial evaluating Pitavastatin and Placebos for HIV-1 Infection. Completed, enrolled 602 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesPuerto Rico, United States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartMar 14, 2017
Primary CompletionAug 21, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.3 years ago

Interventions

Pitavastatindrug

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

Placebosdrug

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