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NCT03825536 · ClinicalTrials.gov registry record · Phase 4
Effect of Methamphetamine on Residual Latent HIV Disease Study
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT03825536: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT03825536 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03825536, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized populations who are most likely to benefit from an HIV cure but possess poorer immune responses. For this study, HIV+ infected ART-suppressed individuals with no prior history of MA use disorder will be administered oral methamphetamine (the maximum FDA approved daily dose for the treatment of childhood obesity) to determine the effects of short-term MA exposure on residual virus production, gene expression, and inflammation. Measures of MA exposure in urine and serum will then be associated with residual virus production, gene expression, cell surface immune marker protein expression, and systemic markers of inflammation. The clinical trial data will generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in HIV+ individuals who use MA.
Primary Outcome
The change in HIV reservoir size (as measured by cell-associated HIV RNA levels) over a 4 hour study period.
Interventions
- OTHER Placebo oral capsule
- DRUG Oral Methamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-01-11 |
| Phase | Phase 4 |
What the finished NCT03825536 record still lists
NCT03825536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03825536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03825536 about?
NCT03825536 is a clinical study titled "Effect of Methamphetamine on Residual Latent HIV Disease Study". The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized ...
What is the current status of trial NCT03825536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2021-01-01. Estimated completion is 2023-01-11.
What interventions are being tested in trial NCT03825536?
The interventions under investigation include: Placebo oral capsule (OTHER), Oral Methamphetamine (DRUG).
Who is sponsoring clinical trial NCT03825536?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03825536's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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