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NCT03070223 · ClinicalTrials.gov registry record · Phase 3
PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)
A Phase 3 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
NCT03070223: Completed Phase 3 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT03070223 is a Phase 3 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 602 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070223, a Phase 3 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
Study 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.
Primary Outcome
Chair rise rate was calculated as the number of chair stands performed divided by the time to complete 10 chair stands. Participants unable to attempt the test were assigned the worst time (9 seconds/stand for every stand not done). Linear mixed effects models for repeated measures were used to estimate annualized rate of change (slope), and the difference between treatment groups (interaction between slope and treatment group). Negative annualized rate of change reflects decline over time, posi
Interventions
- DRUG Placebos
- DRUG Pitavastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2023-08-21 |
| Phase | Phase 3 |
What the finished NCT03070223 record still lists
NCT03070223 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03070223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070223 about?
NCT03070223 is a clinical study titled "PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)". 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 ...
What is the current status of trial NCT03070223?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2017-03-14. Estimated completion is 2023-08-21.
What interventions are being tested in trial NCT03070223?
The interventions under investigation include: Placebos (DRUG), Pitavastatin (DRUG).
Who is sponsoring clinical trial NCT03070223?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070223's enrollment target sits among peer trials
602 607th of 2000 higher than 1,393 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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