Oral Methamphetamine for HIV Infections

Phase-Based Estimates
3
Effectiveness
3
Safety
San Francisco General Hospital, San Francisco, CA
HIV Infections+3 More
Oral Methamphetamine - Drug
Eligibility
18+
All Sexes
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether methamphetamine may have positive impacts for individuals with HIV.

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Eligible Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection
  • Methamphetamine Dependence

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Oral Methamphetamine will improve 1 primary outcome and 3 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of 4 hours.

4 hours
HIV transcription (cell-associated HIV RNA) in peripheral blood
Host gene expression (RNA sequencing) in peripheral blood
Systemic inflammation (plasma pro-inflammatory cytokine levels)
Trace amine receptor 1 (TAAR1) signaling metabolite levels in in peripheral blood

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo oral capsule
Oral methamphetamine
Placebo group

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Methamphetamine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Oral methamphetamine
Drug
Participants will be randomized to either oral methamphetamine versus placebo treatment first using a random number generator. Whichever treatment the participant receives first, they will receive the other treatment (placebo or oral methamphetamine) for their second treatment phase starting at approximately Day 77. For the experimental treatment arm, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Placebo oral capsule
Other
Participants will be randomized to either oral methamphetamine versus placebo treatment first using a random number generator. Whichever treatment the participant receives first, they will receive the other treatment (placebo or oral methamphetamine) for their second treatment phase starting at approximately Day 77. For the placebo treatment arm, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 hours for reporting.

Closest Location

San Francisco General Hospital - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 (<40 copies/ml) 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 <40 copies/ml.
Willing and able to provide written informed consent
No plans to modify ART during the study period (146 days, or approximately 5 months)
Screening CD4+ (cluster of differentiation 4) T-cell count ≥ 350 cells/mm3
Screening hemoglobin ≥ 12.5 g/dL
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.
Willingness to use two forms of contraception throughout the study period as well as up to 30 days after the last day of study completion.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is hiv infections?

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HIV infections are the infection that causes AIDS. This infection can also cause other diseases like Hepatocellular Carcinoma. This can happen just when HIV infection is present or gone. The patient should be monitored and treated here.

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What causes hiv infections?

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Risk factors include poor sanitation, unprotected sexual behavior, and multiple sex partners. To prevent the spread of HIV, the World Health Organization's global strategy is to prevent transmission by reducing partners' risk by providing antiretroviral treatment and counseling. Furthermore, education campaigns are essential to raise awareness of the preventive strategies. It is important to recognize the social dimensions of HIV/AIDS because of the consequences of the disease, such as stigmatization of the carriers and of the people living with the disease.

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What are the signs of hiv infections?

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Early signs of HIV infections include genital pain and bleeding in the genital region of the female patient or hiv positive male patients. When the hiv positive person has unprotected sex with a partner infected with HIV then a partner getting an STD is also a risk factor for HIV infection.

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Can hiv infections be cured?

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Very rarely an AIDS patient with an early illness could be successfully treated and cured of the virus from pre-existing opportunistic infection prior to antiretroviral therapy. However, very early and aggressive medical treatment is necessary to prevent development of the virus.

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How many people get hiv infections a year in the United States?

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About 1.5 million new sexually acquired infections (STDs) (mainly chancroid, syphilis, and HIV) occur each year. The number of newly infected persons with STDs may be as high as 2 to 3 million annually. Most of the new STDs, although uncommon in older adults (age 50 to 59), are common among younger adolescents (age 15 to 19). In 2005, 1.5 million new STD cases occurred in persons under 19 years of age.

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What are common treatments for hiv infections?

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It is evident that a range of medications are used to treat hiv infections. HIV can be treated with a combination of antiretrovirals (ARVs, including protease inhibitors), nucleoside reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). The choice of ARV depends on the patient's viral load and the drug's potency and side effects. However, no consistent pattern exists and patients may need other medications in conjunction or as an alternate to their initial drug regimen.

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Does oral methamphetamine improve quality of life for those with hiv infections?

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This analysis indicates that the use of oral methamphetamine is a significant factor in the perceived health status of HIV+ people that is not adequately addressed by currently available treatment guidelines. This highlights the importance of more research into the use of methamphetamine by those living with hiv.

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Who should consider clinical trials for hiv infections?

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In our study, hiv-discordant couples had a low likelihood of receiving clinical trial treatment compared with noninfected, single, and mixed-serodiscordant couples, even after adjusting for other risk factors. Recent findings support the notion of [considering HIV status when selecting clinical trials for HIV-positive patients for the purpose of providing evidence-based medicine in resource-limited settings] (www.science-behavior.

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Is oral methamphetamine safe for people?

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Methamphetamine appears to be safe, if used in a carefully considered way by people with a clinical history and a full medical and mental health history.

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What are the latest developments in oral methamphetamine for therapeutic use?

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Findings from a recent study show that new oral therapies currently researched will improve the pharmacokinetics, pharmacodynamics, and tolerability of oral M. The new oral M drugs may increase the drug bioavailability and reduce its first pass metabolism. The drugs will be more convenient for use (i.e., shorter period of time for administration, lesser requirement for compliance, better overall compliance for the patients). M-oral drugs are likely to be prescribed less frequently for the treatment of stimulant dependence and for a broader range of indications as compared with current treatments for stimulant abuse.

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How does oral methamphetamine work?

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Current knowledge suggests that meth (primarily orally) can be addictive and increase relapse in subjects with a history of addiction. The high rate of relapse is alarming and highlights the need for more rigorous research investigating other routes of administration, the optimal dose, and the pharmacokinetics and metabolic effects of oral meth. In addition, the effects of meth in other drug-using populations are intriguing and need to be studied further.

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Have there been any new discoveries for treating hiv infections?

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While new drugs continue to be developed, there has been a lack of new discoveries regarding drugs to treat human immunodeficiency virus infections. Current drug candidates focused on combating HIV are aimed at a very specific target of the virus, the HIV envelope protein gp120.

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