Phase 4
N=14
Effect of Methamphetamine on Residual Latent HIV Disease Study
HIV-1-infection · Methamphetamine-dependence
Bottom Line
View on ClinicalTrials.gov: NCT03825536 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood — 10.45; 57.38 copies/million cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Methamphetamine (Drug); Placebo oral capsule (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood |
10.45; 57.38 | — |
| SECONDARY Systemic Inflammation (Plasma Pro-inflammatory Cytokine Levels) |
0.875; 0.054 | — |
| SECONDARY Change in the Frequency of Non-classical Monocyte Cells, as Measured With Flow Cytometry |
6.519; 7.476 | — |
| SECONDARY Trace Amine Receptor 1 (TAAR1) Signaling Metabolite Levels in in Peripheral Blood |
-215.901; -171.506 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 and ≤ 65 years
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
- Continuous therapy with a Department of Health and Human Services (DHHS) recommended/alternative combination ART for least 24 months (at least 3 agents) at study entry with no regimen changes in the preceding 12 weeks
- Maintenance of undetectable plasma HIV-1 RNA ( 160 on more than one occasion.
- History of glaucoma.
- Significant myocardial disease (current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.
- History of psychotic symptoms (e.g., hallucinations, delusional thinking).
- History of bipolar disorder.
- Significant respiratory disease requiring oxygen.
- A history of hypersensitivity to sympathomimetic amines (e.g., epinephrine, norepinephrine, or dopamine).
- Diabetes or current hypothyroidism.
- Participants of reproductive potential or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test at screening. All participants of childbearing potential must agree to use a double-barrier method of contraception throughout the study period and up to 90 days after the last dose of MA.
- Exposure to any immunomodulatory drug (including maraviroc) in the 16 weeks prior to study.
- Prior or current use of experimental agents used with the intent to perturb the HIV-1 viral reservoir.
- History of seizures, psychosis, abnormal electroencephalogram or brain damage with significant persisting neurological deficit
- Recent vaccination within the last 2 weeks prior to study baseline visit. Routine or standard of care vaccinations (such as influenza, pneumococcal, and meningococcal vaccinations) are allowed but must be administered greater than 14 days prior to baseline study visit.
Data sourced from ClinicalTrials.gov (NCT03825536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.