At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 and ≤65 years
- ✓Documented HIV-1 infection confirmed by licensed Western blot or second antibody test or HIV-1 antigen or plasma HIV-1 RNA viral load
- ✓Continuous DHHS-recommended/alternative combination ART (≥3 agents) for ≥24 months with no regimen changes in preceding 12 weeks
- ✓Undetectable plasma HIV-1 RNA (<40 copies/ml) for ≥12 months; isolated episodes of 50-500 copies/ml allowed if subsequent RNA <40 copies/ml
- ✕History of methamphetamine use disorder by DSM-5 criteria
- ✕Evidence of MA use other than administered study drug based on urine, hair, or serum measurements at baseline and follow-up
- ✕Current use of prescription amphetamine-type stimulants (Adderall, Dexedrine, Ritalin, etc.) within last 1 year
- ✕Sensitivity or allergy to amphetamine-type stimulants
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Short-term Effects of Methamphetamine Exposure on Residual Viral Transcription During Treated HIV Disease
In Brief
A Phase 4 clinical trial evaluating Oral Methamphetamine and Placebo oral capsule for HIV-1-infection and Methamphetamine-dependence. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The most commonly used illicit stimulant in HIV-infected individuals 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, HIV+ infected ART-suppressed individuals with no prior history of MA use disorder will be administered oral methamphetamine (the maximum FDA approved daily dose for the treatment of childhood obesity) 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. The clinical trial data will generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in HIV+ individuals who use MA.
Study Details
Timeline
Interventions
An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.