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Clinical trial

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

ID
Name
ACTG A5361s
Description
Aging with HIV may be related to an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or 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 substudy is being done to determine the impact of the drug pitavastatin on muscle.
Trial arms
Trial start
2017-02-28
Estimated PCD
2023-08-21
Trial end
2023-08-21
Status
Completed
Treatment
Pitavastatin
One tablet (4 mg) taken once daily, orally with or without food
Arms:
Experimental: Pitavastatin
Placebos
One tablet taken once daily, orally with or without food
Arms:
Placebo Comparator: Placebo
Size
602
Primary endpoint
Rate of change in chair rise rate
Baseline and months 12, 24, 36 and 48
Rate of change in Inflammatory Index Score (IIS)
Baseline and 12 months
Rate of change in paraspinal muscle density
Baseline and 24 months
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Inability to ambulate independently (use of a cane or a walker is permitted) or rise from a chair without assistance.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 602, 'type': 'ACTUAL'}}
Updated at
2023-08-30

1 organization

2 products

1 indication

Organization
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Product
Pitavastatin
Indication
HIV-1 Infection
Product
Placebos