Phase 3
Completed N=602
PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)
Source: ClinicalTrials.gov NCT03070223 ↗Enrolled (actual)
602
Serious AEs
—
Results posted
Oct 2024
Primary outcomePrimary: Physical Function: Rate of Change in Chair Rise Rate — -0.035; 0.07 rises/minute per year — p=0.31
◆ Published Evidence
Established
34citations · ~6 / year
Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE.
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.
Linked Publications (4)
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Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE.
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Associations of Muscle Density and Area With Coronary Artery Plaque and Physical Function.
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Cytomegalovirus IgG is Associated With Physical Function But Not Muscle Density in People With HIV.
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Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function.
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 |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03070223) and the linked publication. 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. Informational only — not medical advice.