HIV -1 InfectionPhase 4EMRLHDNCT07584369
Short-term Effects of Methamphetamine on Residual Latent HIV Disease Study
A Phase 4 study testing Oral Methamphetamine in people with HIV -1 Infection and Methamphetamine Use, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV -1 Infection, Methamphetamine Use
- What is being tested?
- Oral Methamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to May 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Short-term Effects of Methamphetamine on Residual Latent HIV Disease (EMRLHD) Study
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
- Being tested
- Oral Methamphetamine, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral MethamphetamineDrug
Also called Desoxyn
25mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered.
Placebo oral capsuleDrug
Also called Placebo
One placebo capsule will be administered orally on treatment day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral Methamphetamine; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood
The change in HIV reservoir size (as measured by cell-associated HIV RNA levels).
Measured: 8 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sulggi Lee, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584369
- Sponsor's protocol ID
- 25-44317
- Other IDs
- RM1DA063218
- Acronym
- EMRLHD
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Methamphetamine on Residual Latent HIV Disease (EMRLHD) Study
- ClinicalTrials.gov ID
- NCT07584369
- Acronym / sponsor ID
- EMRLHD / 25-44317
- Conditions
- HIV -1 Infection, Methamphetamine Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral methamphetamine, then Placebo oral capsule | Experimental | Drug: Oral Methamphetamine, Drug: Placebo oral capsuleParticipants 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. |
| Placebo oral capsule, then Oral methamphetamine | Experimental | Drug: Oral Methamphetamine, Drug: Placebo oral capsuleParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral MethamphetamineAlso: Desoxyn25mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered. | Drug | Oral methamphetamine, then Placebo oral capsule, Placebo oral capsule, then Oral methamphetamine |
| Placebo oral capsuleAlso: PlaceboOne placebo capsule will be administered orally on treatment day. | Drug | Oral methamphetamine, then Placebo oral capsule, Placebo oral capsule, then Oral methamphetamine |
Primary outcome
HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood
Time frame: 8 hours after drug administration
The change in HIV reservoir size (as measured by cell-associated HIV RNA levels).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sulggi Lee, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Methamphetamine in people with HIV -1 Infection and Methamphetamine Use, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sulggi A Lee, MD, PhD ((415) 735-5127, sulggi.lee@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood (time frame: 8 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.