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NCT07584369 · ClinicalTrials.gov registry record · Phase 4

Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study

A Phase 4 study, sponsored by University of California, San Francisco.

Not yet
Registry status
Phase 4
Development phase
20
Enrollment target

NCT07584369: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.

NCT07584369 is a Phase 4 study that has not yet begun recruiting, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07584369, a Phase 4 study, has not yet begun recruiting, sponsored by University of California, San Francisco.

NOT YET RECRUITING
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

The most commonly used illicit stimulant in people with HIV (PWH) 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, N = \~20 PWH virally-suppressed on antiretroviral therapy (ART) with no prior history of MA use disorder will be administered oral methamphetamine 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. Thus, the proposed work will leverage a unique clinical trial design to generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in PWH who use MA.

Primary Outcome

The change in HIV reservoir size (as measured by cell-associated HIV RNA levels).

Interventions

  • DRUG Placebo oral capsule
  • DRUG Oral Methamphetamine

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-07-01
Est. Completion 2030-05
Phase Phase 4

What is known before NCT07584369 opens enrollment

NCT07584369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.

NCT07584369 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07584369 about?

NCT07584369 is a clinical study titled "Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study". The most commonly used illicit stimulant in people with HIV (PWH) 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 pop...

What is the current status of trial NCT07584369?

This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2026-07-01. Estimated completion is 2030-05.

What interventions are being tested in trial NCT07584369?

The interventions under investigation include: Placebo oral capsule (DRUG), Oral Methamphetamine (DRUG).

Who is sponsoring clinical trial NCT07584369?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07584369's enrollment target sits among peer trials

20 1753rd of 2000 higher than 167 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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Source: ClinicalTrials.gov NCT07584369, the US trial registry maintained by the National Library of Medicine. NCT07584369 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.