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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07584369
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • HIV -1 Infection
  • Methamphetamine Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral Methamphetamine — DRUG
    25mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered.
  • Placebo oral capsule — DRUG
    One placebo capsule will be administered orally on treatment day.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Oral methamphetamine, then Placebo oral capsule
    Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. 25mg of oral methamphetamine will be administered on three consecutive days. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on three consecutive days.
  • Experimental: Placebo oral capsule, then Oral methamphetamine
    Participants will be randomized to placebo capsule first then oral methamphetamine using a random number generator. A placebo oral capsule will be administered on three consecutive days. Then the participant will receive the 25mg of oral methamphetamine for their second treatment phase starting at approximately Day 77. For the treatment, one capsule will be administered orally on three consecutive days.

Primary Outcome Measure

HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood [ Time Frame: 8 hours after drug administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94110-

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University of California, San Francisco· San Francisco, CA

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