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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 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03825536
The ClinicalTrials.gov registry entry for NCT03825536 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03825536 reports 0 study locations.
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.
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