Methamphetamine for HIV
(EMRLHD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Sulggi Lee, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults (18-64) living with HIV who have been on stable, effective HIV treatment for at least a year and have undetectable viral loads. Participants must not have a history of methamphetamine use disorder, be willing to use two forms of contraception, and commit to the study's duration.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive oral methamphetamine or placebo for three consecutive days
Washout Period
Participants undergo a washout period before the second treatment phase
Treatment Phase 2
Participants receive the alternate treatment (placebo or oral methamphetamine) for three consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Methamphetamine
Trial Overview
The study tests short-term effects of taking oral methamphetamine versus a placebo in people with well-controlled HIV. Researchers will look at how meth affects hidden virus levels, gene activity, immune markers, and inflammation over about 4-5 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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