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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.
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
AMOHI-1 Trial 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.Check my eligibility
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.See study design
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.
AMOHI-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh over 110 pounds and my BMI is over 20.
Select...
I weigh over 110 pounds and my BMI is over 20.
Select...
I have HIV with a CD4 count under 350 and a viral load over 10,000.
AMOHI-1 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sCD14
Secondary outcome measures
Addiction clinical outcomes: Change in Drug use
Addiction clinical outcomes: Medication for opioid use disorder (MOUD)
HIV-related clinical outcomes: Viral load
+21 moreAMOHI-1 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
Buprenorphine/naloxone
2010
Completed Phase 4
~2460
Methadone
2005
Completed Phase 4
~2930
Find a Location
Who is running the clinical trial?
IMEA ParisUNKNOWN
Ho Chi Minh City CDCUNKNOWN
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,062 Total Patients Enrolled
13 Trials studying Inflammation
1,375 Patients Enrolled for Inflammation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have either not started cART or have been on it for no more than 3 months.I do not have any major health issues that could make participating dangerous for me.I do not have active tuberculosis or any AIDS-related illnesses.I have cancer or another type of malignancy.I am willing to start or have started combination antiretroviral therapy (cART) within the last 3 months.I weigh over 110 pounds and my BMI is over 20.I am open to being assigned to any of the listed medication treatments.I weigh over 110 pounds and my BMI is over 20.I have either not started cART or have been on it for no more than 3 months.My liver is severely damaged.I am not pregnant, not breastfeeding, and either cannot conceive or will use birth control.I have HIV with a CD4 count under 350 and a viral load over 10,000.I am currently using drugs that modify my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Buprenorphine/naloxone
- Group 2: XR-Naltrexone
- Group 3: Methadone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To which demographic is enrollment of this trial open?
"To gain admittance to this experiment, participants must be diagnosed with inflammation and aged between 18-65. This trial is looking for a total of 225 volunteers."
Answered by AI
Is enrollment for this experiment open to persons over the age of 35?
"The requirements of this experiment necessitate that study participants are aged between 18 and 65. According to the available data, there are 319 clinical trials specifically for individuals under 18 and 1302 studies targeting those over 65 years old."
Answered by AI
Has the U.S. Food and Drug Administration sanctioned Buprenorphine/naloxone for public use?
"Buprenorphine/naloxone is rated 2 on the safety scale, since this Phase 2 trial has provided evidence of its security but not yet demonstrated positive results in terms of efficacy."
Answered by AI
To what extent are participants participating in this experiment?
"That is correct. As per the information on clinicaltrials.gov, this trial is currently seeking patients after being initially posted on January 30th 2023 and updated most recently on July 6th 2023. Currently 225 participants need to be found from a single site of recruitment."
Answered by AI
Is there any availability for patients to join this clinical trial?
"Yes, according to clinicaltrials.gov the trial that was initially shared on January 30th 2023 is currently recruiting participants. Its most recent update happened on July 6th 2023 and it's looking for 225 individuals from 1 location."
Answered by AI
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