HIV -1 Infection, Methamphetamine Use
Conditions
Brief 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.
Interventions
25mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered.
DRUGPlacebo oral capsule
One placebo capsule will be administered orally on treatment day.
Sponsors
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Maintenance of undetectable plasma HIV-1 RNA ( \<40copies/ml) below the limit of quantification for at least 12 months. Episodes of single HIV plasma RNA 50-500 copies/ml will not exclude participation if subsequent HIV plasma RNA is below the limit of assay detection * No plans to modify ART during the study period (approximately 4-5 months) * Participant and partner(s) are willing to use two forms of contraception throughout the study period as well as up to 60 days after the last day of study completion * Ability and availability to participate in the full duration of the study (approximately 4-5 months) and maintain the inclusion/
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood | 8 hours after drug administration | The change in HIV reservoir size (as measured by cell-associated HIV RNA levels). |
Countries
United States
Contacts
CONTACTSulggi A Lee, MD, PhD
PRINCIPAL_INVESTIGATORSulggi Lee, MD, PhD
University of California, San Francisco
Outcome results
None listed