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

NCT07584369 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 25-44317RM1DA063218
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV -1 Infection; Methamphetamine Use

Outcome Measures

Primary Outcomes (1)

• HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood

  The change in HIV reservoir size (as measured by cell-associated HIV RNA levels).

  8 hours after drug administration

Study Arms (2)

Oral methamphetamine, then Placebo oral capsule

EXPERIMENTAL

Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. 25mg of oral methamphetamine will be administered on three consecutive days. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on three consecutive days.

Drug: Oral Methamphetamine; Drug: Placebo oral capsule

Placebo oral capsule, then Oral methamphetamine

EXPERIMENTAL

Participants will be randomized to placebo capsule first then oral methamphetamine using a random number generator. A placebo oral capsule will be administered on three consecutive days. Then the participant will receive the 25mg of oral methamphetamine for their second treatment phase starting at approximately Day 77. For the treatment, one capsule will be administered orally on three consecutive days.

Drug: Oral Methamphetamine; Drug: Placebo oral capsule

Interventions

Oral Methamphetamine DRUG

25mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered.

Also known as: Desoxyn

Oral methamphetamine, then Placebo oral capsule; Placebo oral capsule, then Oral methamphetamine

Placebo oral capsule DRUG

One placebo capsule will be administered orally on treatment day.

Also known as: Placebo

Oral methamphetamine, then Placebo oral capsule; Placebo oral capsule, then Oral methamphetamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Sulggi Lee, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sulggi A Lee, MD, PhD

CONTACT

(415) 735-5127; sulggi.lee@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)