Methamphetamine for HIV

(EMRLHD Trial)

SA
Overseen BySulggi A Lee, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how short-term exposure to methamphetamine affects individuals with HIV who are effectively managing the virus with antiretroviral therapy. Researchers aim to determine if methamphetamine alters the remaining viral load, influences gene activity, or causes inflammation. Participants must be HIV-positive, have maintained consistent HIV treatment for at least a year, and have no history of methamphetamine use disorder. The goal is to discover new strategies to target HIV in those who might use methamphetamine, ultimately aiding in the fight against the virus. As a Phase 4 trial, this research examines an FDA-approved treatment to assess its benefits for a broader patient population, offering participants the opportunity to contribute to significant insights.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop taking your current medications, but you must not change your antiretroviral therapy (ART) during the study. Additionally, you cannot use certain medications like amphetamine-type stimulants or specific drugs that might interact with methamphetamine.

What is the safety track record for methamphetamine in this trial?

Research has shown that methamphetamine (MA) use can cause health problems for people living with HIV (PLWH). Studies indicate that methamphetamine use can make controlling the HIV virus more difficult, leading to worse health outcomes and more missed doses of HIV medication, complicating HIV management.

The trial you might join is in a later stage, indicating that substantial information about the treatment's safety already exists. While methamphetamine carries known risks, particularly concerning addiction and health effects, the trial is designed to closely monitor and manage these risks. Researchers carefully select and monitor participants to ensure their safety.

In summary, although methamphetamine poses known risks, especially for those with HIV, the clinical trial is structured to protect participants.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for HIV, which typically involve antiretroviral therapy (ART) to manage the virus, this trial is exploring the use of methamphetamine as a potential treatment. Researchers are curious about methamphetamine because it offers a completely different approach, targeting the brain's neurotransmitter systems rather than directly acting on the virus itself. This trial is particularly intriguing because it could uncover new insights into how methamphetamine might influence HIV progression or symptoms, potentially leading to novel therapeutic pathways.

What evidence suggests that methamphetamine might be an effective treatment for HIV?

This trial will explore the effects of methamphetamine on individuals with HIV. Research has shown that methamphetamine use leads to worse health outcomes for people with HIV. Studies have found that methamphetamine reduces the effectiveness of HIV treatments, making virus control more difficult. Users of this drug often miss more medical appointments and have a lower chance of managing the virus effectively. Methamphetamine also causes the immune system to become overactive and exhausted, weakening its ability to fight infections. Overall, while methamphetamine might be used in some research settings, its general use is linked to negative effects on managing HIV.14678

Who Is on the Research Team?

SL

Sulggi Lee, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults (18-64) living with HIV who have been on stable, effective HIV treatment for at least a year and have undetectable viral loads. Participants must not have a history of methamphetamine use disorder, be willing to use two forms of contraception, and commit to the study's duration.

Inclusion Criteria

I have tested positive for HIV-1 infection.
I have been on the same combination HIV treatment for at least 12 months.
I am able and available to participate in the study for 4-5 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive oral methamphetamine or placebo for three consecutive days

3 days
1 visit (in-person)

Washout Period

Participants undergo a washout period before the second treatment phase

Approximately 11 weeks

Treatment Phase 2

Participants receive the alternate treatment (placebo or oral methamphetamine) for three consecutive days

3 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Methamphetamine

Trial Overview

The study tests short-term effects of taking oral methamphetamine versus a placebo in people with well-controlled HIV. Researchers will look at how meth affects hidden virus levels, gene activity, immune markers, and inflammation over about 4-5 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Placebo oral capsule, then Oral methamphetamineExperimental Treatment2 Interventions
Group II: Oral methamphetamine, then Placebo oral capsuleExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Impact of Methamphetamine Use on HIV and Other Health ...

Methamphetamine use is prevalent among PWH at the UCSD HIV Medicine Owen Clinic and is associated with decreased HIV viral suppression and increased missed HIV ...

The Complex Interaction between Methamphetamine Abuse ...

METH use has been linked to worsening of HIV-1 disease and AIDS-related outcomes [7, 30, 31, 32, 33]. Moreover, in vitro and animal studies demonstrate that ...

High Rates of Meth Use Seen in California HIV Clinic

Methamphetamine use was associated with missed HIV care visits, lower likelihood of viral suppression, and greater likelihood of a low CD4 count ...

Assessment Methods of Methamphetamine Use in HIV ...

Background Methamphetamine (MA) use is disproportionately higher among people living with HIV (PWH) and contributes to adverse clinical outcomes ...

Crystal methamphetamine use and HIV medical outcomes ...

This analysis showed a significant independent association between crystal meth use and unsuppressed viral load among MSM in an HIV service population.

METHAMPHETAMINE and HIV - Ryan White HIV/AIDS Program

And with studies showing that 86 percent of inpatient treatment meth users are HIV infected, the sad realities of the epidemic are clear. That is why providers ...

Intravenous methamphetamine use, HIV Status and PrEP ...

Methamphetamine use is prevalent among sexual and gender minority (SGM) populations and is associated with increased risk for HIV acquisition.

Methamphetamine Use and HIV Risk Behaviors Among ...

Meth use was associated with increased HIV infections among MSM in San Francisco who were tested for HIV during 2001--2002 (3). Results from the ...