Phase 3 N=602 Randomized Quadruple-blind Prevention

PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)

HIV-1 Infection

Bottom Line

View on ClinicalTrials.gov: NCT03070223 ↗

Enrolled (actual)

602

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: Physical Function: Rate of Change in Chair Rise Rate — -0.035; 0.07 rises/minute per year — p=0.31

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pitavastatin (Drug); Placebos (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Physical Function: Rate of Change in Chair Rise Rate	-0.035; 0.07	0.31
PRIMARY Mechanistic: Rate of Change in Inflammatory Index Score (IIS)	—	—
PRIMARY Muscle Quality: Paraspinal Muscle Density	36.8; 36.4; 36.2; 35.4	0.62
SECONDARY Physical Function: Rate of Change in Gait Speed	-0.013; -0.012	0.61
SECONDARY Physical Function: Rate of Change in Grip Strength	-0.39; -0.36	0.80
SECONDARY Physical Function: Rate of Change in Risk of Impairment According to Balance	1.08; 1.06	0.33
SECONDARY Physical Function: Rate of Change in Modified SPPB Score	-0.019; -0.014	0.18
SECONDARY Physical Function: Rate of Change in Risk of Impairment According to SPPB	1.00; 0.95	0.47
SECONDARY Physical Function: Impairment According to DASI	219; 192; 74; 66; 23; 26	—
SECONDARY Frailty Phenotype	74; 65; 65; 45; 5; 10	—
SECONDARY Physical Activity: Frequency of <30 Minutes of Physical Activity 3 or More Days a Week	140; 137; 92; 82; 83; 66	—
SECONDARY Physical Activity: Frequency of Watching >2 Hours of TV or Videos a Day	67; 48; 88; 92; 158; 144	—
SECONDARY Muscle Quality: Pectoral Muscle Density	41.4; 40.9; 41.5; 41.8	0.55
SECONDARY Muscle Quality: Infraspinatus Muscle Density	44.3; 42.6; 44.2; 44.0	0.67
SECONDARY Muscle Area: Paraspinal Muscle Area	12.0; 12.5; 12.1; 12.5	0.98
SECONDARY Muscle Area: Pectoral Muscle Area	8.3; 8.6; 8.2; 8.7	0.31
SECONDARY Muscle Area: Infraspinatus Muscle Area	6.3; 6.3; 6.5; 6.2	0.21
SECONDARY Mechanistic: Serum Concentrations of Biomarkers	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03070223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.