Phase 3
N=114
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Opioid-use Disorder · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT03275350 ↗Enrolled (actual)
114
Serious AEs
10.5%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed — 23; 21; 29; 29 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naltrexone Injectable Suspension (Drug); Treatment as usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed |
23; 21; 29; 29 | — |
| PRIMARY Number of Participants With HIV Viral Suppression, Complete Case |
23; 19; 26; 26 | — |
| PRIMARY Number of Participants With HIV Viral Suppression, Per-protocol |
11; 16; 15; 23 | — |
| SECONDARY Veterans Aging Cohort Study (VACS) Index |
65.1; 68.4; 54.4; 63.5 | — |
| SECONDARY CD4 Count |
380.7; 439.8; 459.1; 505.1 | — |
| SECONDARY Engagement in HIV Care: Antiretroviral Therapy Prescribed |
37; 46; 45; 43 | — |
| SECONDARY Engagement in HIV Care: 100% Antiretroviral Therapy Adherence |
16; 13 | — |
| SECONDARY Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks |
31; 29 | — |
| SECONDARY Number of Participants Who Had Unprotected Sex in Past 30 Days |
15; 16; 9; 9 | — |
| SECONDARY Number of Participants With Multiple Sex Partners in Past 30 Days |
10; 6; 5; 6 | — |
| SECONDARY Engagement in HIV Care: Quality of Life |
58; 64.3; 67.9; 71.2 | — |
| SECONDARY Average Number of Self-Reported Days of Opioid Use in Last 30 Days |
11.73; 14.81; 6.02; 13.58 | — |
| SECONDARY Number of Participants Who Test Positive for Opioids at 24 Weeks |
34; 40; 10; 30 | — |
Summary
The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.
Eligibility Criteria
Inclusion Criteria
- Participant is at least 18 years old
- Participant has provided written informed consent and HIPAA for medical record abstraction
- Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
- Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
- Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
- Willing to establish ongoing HIV care at the site if not already receiving ongoing care
- If female, willing to take at least one evidence-based measure to avoid becoming pregnant
Exclusion Criteria
- Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
- Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
- Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
- Suicidal or homicidal ideation requiring immediate attention
- Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
- Participant has an international normalized ratio (INR) > 1.5 or platelet count <100k
- Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent
- Anticipate undergoing surgery during study participation
- Have chronic pain requiring ongoing pain management with opioid analgesics
- If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months
- Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)
- Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening
- Have taken an investigational drug in another study within 30 days of study consent
- Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent
- Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study
Data sourced from ClinicalTrials.gov (NCT03275350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.