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Combined LAI Treatment for HIV/AIDS and Opioid Use Disorder (CHOICE Trial)

Phase < 1
Recruiting
Led By Kirsten K Langdon, Ph.D.
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore how new long-acting HIV and opioid addiction medications may be used, and how to promote their uptake. Qualitative interviews will be conducted with stakeholders to understand attitudes, barriers, and facilitators.

Who is the study for?
This trial is for individuals aged 18-65 with HIV and opioid use disorder (OUD), who can communicate in English. They must have a confirmed HIV diagnosis and meet the criteria for OUD. Participants from RIDOC should expect to be released within 6 months. Pregnant or breastfeeding individuals, or those planning pregnancy or treatment for Hepatitis B/C during the study, cannot join.
What is being tested?
The study is testing a combined long-acting injectable treatment regimen: Cabenuva (cabotegravir with rilpivirine) for HIV and Sublocade (extended-release buprenorphine) for OUD. It involves interviews with stakeholders to understand factors affecting this treatment's delivery and acceptance over one year.
What are the potential side effects?
Potential side effects of Cabenuva may include injection site reactions, fever, fatigue, headache, muscle pain; while Sublocade might cause constipation, nausea, vomiting, headache, increased liver enzymes. Side effects vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Feasibility/Acceptability
Recruitment rates
+1 more
Secondary study objectives
HIV Risk Behavior
Overall Quality of life
Substance use
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Preliminary Test of Combined LAI TreatmentExperimental Treatment1 Intervention
The combined injectable treatment includes a dual-administration of rilpivirine (CAB/RPV) "cabenuva" for HIV and extended-release buprenorphine (XR-B) "sublocade" for OUD.

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
263 Previous Clinical Trials
68,539 Total Patients Enrolled
Kirsten K Langdon, Ph.D.Principal InvestigatorRhode Island Hospital

Media Library

Preliminary Test of Combined LAI Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05991622 — Phase < 1
Opioid Use Disorder Research Study Groups: Preliminary Test of Combined LAI Treatment
Opioid Use Disorder Clinical Trial 2023: Preliminary Test of Combined LAI Treatment Highlights & Side Effects. Trial Name: NCT05991622 — Phase < 1
Preliminary Test of Combined LAI Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05991622 — Phase < 1
~11 spots leftby Nov 2025
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