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Opioid Agonist/Antagonist

Medications for Opioid Use Disorder in HIV (AMOHI-1 Trial)

Phase 2

Recruiting

Led By Luis J Montaner, DVM, D.Phil

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a total body weight of more than 50 kg (110 pounds) and a body mass index (BMI) of more than 20 at screening

Has a total body weight of more than 50 kg (110 pounds) and a body mass index (BMI) of more than 20 at screening.

Must not have

Known neurological, cardiovascular, renal, or other significant medical disorder that is likely to impair or make the individual's participation hazardous

Active Tuberculosis or other symptomatic infectious disease AIDS-defining illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week-4, -8, -12, -16, -20, -24, -28, -32, -36, -40, -44, and -48

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to explore how opioids and HIV-1 infection affect the immune system, and if medications can help to restore it.

Who is the study for?

This trial is for adults with HIV and moderate to severe opioid use disorder who haven't started or have just begun antiretroviral therapy. They must be in stable health, not pregnant or breastfeeding, able to consent, and willing to take methadone, buprenorphine/naloxone, or extended-release naltrexone.

What is being tested?

The study tests how long-term treatments for opioid use disorder (methadone, buprenorphine/naloxone, XR-naltrexone) affect immune system recovery in people with HIV starting antiretroviral therapy.

What are the potential side effects?

Possible side effects include nausea, headaches, dizziness from buprenorphine/naloxone; constipation and sweating from methadone; injection site reactions and insomnia from XR-naltrexone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh over 110 pounds and my BMI is over 20.

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I weigh over 110 pounds and my BMI is over 20.

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I have HIV with a CD4 count under 350 and a viral load over 10,000.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health issues that could make participating dangerous for me.

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I do not have active tuberculosis or any AIDS-related illnesses.

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I have cancer or another type of malignancy.

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My liver is severely damaged.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week-4, -8, -12, -16, -20, -24, -28, -32, -36, -40, -44, and -48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week-4, -8, -12, -16, -20, -24, -28, -32, -36, -40, -44, and -48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week-4, -8, -12, -16, -20, -24, -28, -32, -36, -40, -44, and -48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sCD14

Secondary study objectives

Addiction clinical outcomes: Change in Drug use

Addiction clinical outcomes: Medication for opioid use disorder (MOUD)

HIV-related clinical outcomes: Viral load

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: XR-NaltrexoneExperimental Treatment1 Intervention

Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with monthly injection extended-release naltrexone (XR-NTX) and antiretroviral therapy (cART).

Group II: MethadoneExperimental Treatment1 Intervention

Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone (MET) and antiretroviral therapy (cART).

Group III: Buprenorphine/naloxoneExperimental Treatment1 Intervention

Participants in this arm will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine/naloxone and antiretroviral therapy (cART).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methadone

2002

Completed Phase 4

~4460

Buprenorphine/naloxone

2010

Completed Phase 4

~2460