Short-term Effects of Methamphetamine on Latent HIV Study
This study is looking at how a single dose of oral methamphetamine affects the hidden HIV virus in people who are already taking HIV medication (antiretroviral therapy or ART) and have their virus under control. Researchers want to understand if even a short exposure to methamphetamine increases HIV activity, gene expression, and inflammation. You might be able to join if you are 18 to 65 years old, have HIV-1 infection, and have been on stable ART for at least 12 months. The study will involve about 20 participants and will measure HIV transcription (how much the virus is making copies of itself) in your blood 8 hours after taking the study drug.
- Study design
- This interventional study will involve about 20 participants. It will compare the effects of a single dose of oral methamphetamine to a placebo (an inactive capsule).
- What's involved
- You would take either oral methamphetamine or a placebo capsule. Your HIV transcription in peripheral blood will be measured 8 hours after taking the drug.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your HIV transcription will be measured 8 hours after drug administration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07584369
Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study
Not Yet Recruiting
PHASE4Ages 18–65InterventionalBasic scienceUniversity of California, San FranciscoInvestigator-initiated
~20 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Oral MethamphetaminePlacebo oral capsule
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood
Measured over 8 hours after drug administration
Conditions
NCT07584369
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of California, San Francisco
San Francisco, Californiano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sulggi Lee, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Exclusion
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.
Sensitivity or allergy to amphetamine-type stimulants.
Current use of any other "psychoactive" drug within the last 1 month. These include cocaine, ecstasy, lysergic acid diethylamide (LSD), mushrooms, or other recreational drugs - but cannabis, nicotine or caffeine use is ok.
Use of illicit opioids (heroin, fentanyl)- but ok if use of prescription opioid agonists with known prescribed doses, such as methadone, hydrocodone (Norco®), buprenorphine/naloxone (Suboxone®), oxycodone (Oxycontin®), hydromorphone (Dilaudid®) within the past 3 months by self-report and/or urine qualitative screening.
Current moderate to severe use of alcohol use disorder (DSM-5 criteria) as this might put patient at risk of withdrawal during the study.
Recent use within the last month of the following medications given potential interactions with oral methamphetamine: acebrophylline, iobenguane, isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine, asunaprevir, bupropion, topical cocaine, fluoxetine, iohexol, linezolid, paroxetine, potassium citrate, quinidine, sodium bicarbonate, sodium citrate, sodium lactate, tipranavir, and tromethamine.
Recent hospitalization in the last 90 days.
Recent infection in the last 90 days requiring prolonged (e.g., \>3 weeks) of systemic intravenous antibiotics.
Known anemia (HIV+ males Hct\< 34; females Hct\< 32) or contraindication to donating blood.
Screening hemoglobin below 12.5 g/dL
Poorly controlled hypertension or systolic blood pressure \> 140 on repeat measurement in the last 3 months, on more than one occasion.
Significant myocardial disease (e.g., current myocarditis or reduced left ventricular ejection fraction below the lower limit of normal) or diagnosed coronary artery disease.
History of cardiac arrhythmia that needs to be medically treated.
History of psychotic symptoms (e.g., hallucinations, delusional thinking) in the prior 3 months.
History of seizures, abnormal electroencephalogram or brain damage with significant persisting neurological deficit in the past 3 months or currently on anti- seizure medications
Significant respiratory disease requiring oxygen.
Exposure to any immunomodulatory drug (including maraviroc) in the 12 weeks prior to study
Prior or current use of experimental agents used with the intent to perturb the HIV-1 viral reservoir in the 12 weeks prior to study.
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.
Pregnancy. A serum pregnancy test will be performed. If this test is positive, the participant will not be allowed to enter the study since body changes occurring during pregnancy will alter the study results.
Recent vaccination within the last 2 weeks prior to study baseline visit.\* \*Note: Routine or standard of care vaccinations (such as SARS-CoV-2, influenza, pneumococcal, and meningococcal vaccinations) are allowed, but must be administered greater than 14 days prior to baseline study visit. For SARS-CoV-2 vaccination, the last dose must be administered at least 14 days prior to baseline study visit.
What this trial measures
- HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood8 hours after drug administration
The change in HIV reservoir size (as measured by cell-associated HIV RNA levels).