Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Condition: HIV Infections; Opioid-Related Disorders
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Opioid-Related Disorders
Intervention: Buprenorphine/Naloxone
Intervention description: Oral tablet
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Seronegativity; Opiate Addiction; Opiate Dependence

Summary:

      Drug abuse and HIV/AIDS are serious global health problems. Injection drug use is currently
      the major mode of transmission of HIV in many countries. The purpose of this study is to
      determine the effectiveness of drug and risk reduction counseling combined with either
      substitution drug treatment with buprenorphine/naloxone (BUP/NX) or short-term detoxification
      with BUP/NX in preventing HIV transmission among injection drug users. Participants will be
      recruited for this study in China and Thailand.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-uninfected within 28 days of enrollment

          -  Meets DSM-IV criteria for opiate dependence

          -  Positive urine test for opiates

          -  Injected opiates at least 12 times in the 28 days prior to enrollment, according to
             self-report

          -  Willing to use acceptable forms of contraception for the first 12 months of the study

          -  Able to provide contact information and willing to be contacted by study staff as
             necessary

          -  Available for study visits for at least 2 years

        Exclusion Criteria:

          -  Current treatment with methadone, morphine, levo-alpha-acetyl-methadol (LAAM),
             naltrexone, or nalmefene

          -  Currently enrolled in another HIV prevention or drug use intervention study

          -  Known sensitivity to buprenorphine or naloxone

          -  Requires immediate medical attention for dependence on alcohol, benzodiazepines, or
             other substances. People who are dependent on tobacco are not excluded.

          -  Currently injecting drugs of abuse other than opiates, more than twice in the last 28
             days, according to self-report

          -  Psychological disturbance or cognitive impairment that may interfere with the study

          -  Acute or chronic kidney failure

          -  Certain abnormal laboratory values

          -  Any other medical or psychiatric condition that, in the opinion of the investigator,
             would make participation in this study unsafe

          -  Pregnant or breastfeeding

        Inclusion Criteria for Substudy:

          -  Current or former participant in HPTN 058 study in Xinjiang who was actively in the
             long-term treatment arm on stable maintenance dose of Suboxone when detained/arrested
             (last dose within 2 days of incarceration), resulting in immediate cessation of
             Suboxone without tapering

          -  Currently released from detention

          -  Willing to complete one-time questionnaire

          -  Willing to sign informed consent

        Exclusion Criteria for Substudy:

          -  Any medical or psychiatric condition that, in the opinion of the investigator, would
             make participation in the study unsafe, or would otherwise interfere with the study
             objectives or interpretation