title: Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058.
abstract: BACKGROUND
  Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors.
  
  
  METHODS
  We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N=150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models.
  
  
  RESULTS
  BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation.
  
  
  CONCLUSIONS
  In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.
authors.affiliation: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA. glucas@jhmi.edu
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Lucas
authors.forename: Geetha
authors.initials: G
authors.lastname: Beauchamp
authors.forename: Apinun
authors.initials: A
authors.lastname: Aramrattana
authors.forename: Yiming
authors.initials: Y
authors.lastname: Shao
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.forename: Liping
authors.initials: L
authors.lastname: Fu
authors.forename: J Brooks
authors.initials: JB
authors.lastname: Jackson
authors.forename: David D
authors.initials: DD
authors.lastname: Celentano
authors.forename: Paul
authors.initials: P
authors.lastname: Richardson
authors.forename: David
authors.initials: D
authors.lastname: Metzger
mesh_terms: D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000069479:Buprenorphine, Naloxone Drug Combination; D002681:China; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000517:prevention & control; D018023:HIV Seronegativity; D006801:Humans; D008297:Male; D015233:Models, Statistical; D009270:Naloxone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D058850:Opiate Substitution Treatment / Q000379:methods; D009293:Opioid-Related Disorders / Q000150:complications / Q000534:rehabilitation*; D015819:Substance Abuse, Intravenous / Q000150:complications / Q000534:rehabilitation*; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control; D013785:Thailand; D013997:Time Factors
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D009270:Naloxone; D002047:Buprenorphine