HIV clinic-based extended release naltrexone versus treatment as usual for people with HIV and opioid use disorder: A non-blinded, randomised non-inferiority trial.
This is the primary outcomes paper for CTN-0067.
Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. This study tested whether outpatient antagonist treatment with naltrexone could achieve similar results.
This open-label, non-inferiority randomized trial was set in 6 U.S. HIV primary care clinics, enrolling 114 participants with untreated HIV and OUD (62% male; 56% Black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%), and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. Participants were randomized into one of two groups: HIV clinic-based extended-release naltrexone (XR-NTX, n=55) or treatment as usual with buprenorphine or methadone (TAU, n=59). Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA =200 copies/mL) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks.
Fewer XR-NTX participants initiated medication compared with TAU participants (47% vs 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) (risk ratio [RR] 1.064; 95% confidence interval [CI] 0.748, 1.514) at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the prespecified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX vs. TAU (11.7 vs. 14.8 days; mean difference -3.1; 95% CI -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 vs. 13.6, mean difference -7.6; 95% CI -13.8, -0.2).
Conclusions: A randomised controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus (HIV) clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating HIV viral suppression. Participants who initiated extended-release naltrexone used less opioids than those who received treatment as usual.
Related protocols: CTN-0067