Phase 4 N=281 Randomized Treatment

Buprenorphine to Improve HIV Care Engagement and Outcomes

HIV · Substance Related Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01936857 ↗

Enrolled (actual)

281

Serious AEs

5.0%

Results posted

Jun 2020

Primary outcome: Primary: Number of Participants With HIV Viral Suppression — 97; 92; 74; 99 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Buprenorphine/naloxone (Drug); Methadone Maintenance Therapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With HIV Viral Suppression	97; 92; 74; 99	—
PRIMARY Participants With Heroin Use (Urine Drug Screen)	66; 72	—
PRIMARY Participants With Heroin Use (Self-report)	64; 67	—
SECONDARY Number of Participants in Receipt of Antiretroviral Therapy (ART)	108; 116	—
SECONDARY Number of Participants in Retention in HIV Care	111; 118	—

Summary

The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.

Eligibility Criteria

Inclusion Criteria

HIV positive
Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
Urine drug screen positive for opioids
Interested in receiving treatment for opioid dependence
Age at least 18 years old
Willing to practice an effective method of birth control, if female

Exclusion Criteria

Known hypersensitivity to buprenorphine or naloxone
aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit
Currently pregnant or breastfeeding
Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
Methadone maintenance treatment within 30 days of consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01936857). 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.