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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, San Francisco

About 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.

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent

Any gender, age ≥ 18 years < 65 years

Laboratory confirmed documentation of HIV-1 infection.

Continuous therapy with a Department of Health and Human Services (DHHS) recommended/alternative combination ART for least 12 months (at least 3 agents) at study entry with no regimen changes in the preceding 12 weeks

Disqualifiers

No current or prior history of methamphetamine (MA) use disorder by DSM-5 diagnostic criteria. Participants may have a prior history of taking prescription medications containing amphetamines- type stimulants such as Adderall® or Dexedrine® or Ritalin for the treatment of conditions such as attention deficit hyperactivity disorder as long as the participant has not taken these medications in the last 12 months or plans to take these medications during the entire study period

History of methamphetamine ("meth") use disorder by DSM-5 diagnostic criteria using the 11-symptom checklist.

Evidence of MA use other than due to the administered oral methamphetamine study drug, based on urine, hair, or serum MA measurements collected at baseline and follow-up study visits.

Current use of prescription medications containing amphetamine-type stimulants (e. g.,Adderall®, Dexedrine®, Ritalin, etc.) within the past 1 year.

Trial design

Treatments tested in this trial

  • Oral Methamphetamine
  • Placebo oral capsule

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator