• Evidence of HIV-1 infection [ Time Frame: At Week 104 ] [ Designated as safety issue: Yes ]
  

• Continued opiate use as measured by self-report and urinalysis [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Self-reported frequency of injection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Self-reported frequency of injection with previously used injection equipment (needles, syringes, cookers, cottons, and rinse water) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Self-reported frequency of unprotected sex or sex sold/traded for drugs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

Effective HIV prevention among injection drug users (IDUs) requires educating the at-risk population about HIV transmission and risky behavior, and providing the means for behavior change. Current treatment for opiate dependence focuses on reducing the frequency of drug use. BUP/NX is a combination pill currently used to treat opiate-dependent individuals. This trial will evaluate the effectiveness of two therapies in preventing HIV transmission among IDUs. Drug and risk reduction counseling combined with either substitution drug treatment with BUP/NX combined or short-term detoxification with BUP/NX will be compared in preventing the transmission of HIV among opiate-dependent individuals.

This study will last 4.5 years. Participants in this study will be randomly assigned to one of two treatment arms. Group 1 will receive BUP/NX substitution treatment. Group 2 will receive BUP/NX detoxification treatment. An initial 4-week safety and feasibility phase will involve the first 50 participants at each site and will last approximately 16 weeks. Study visits will occur every week and will include a physical exam and blood and urine collection.

Participants in Group 1 will receive BUP/NX under the tongue three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, followed by booster sessions every 4 weeks through Week 52. Participants in Group 2 will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator. The main treatment phase of the study will last 52 weeks. Participants assigned to Group 1 will take part in a BUP/NX reduction phase, which will occur between Weeks 47 and 52. Participants assigned to Group 2 will receive BUP/NX for a maximum of 18 days; detoxification may be repeated at Week 26 if the participant is still injecting opiates.

In addition, drug and risk reduction counseling will occur weekly. After the first 12 weeks, participants will return every 4 weeks for 10 more counseling sessions. HIV testing, risk assessment, and urine tests for opiates will occur at screening and at Weeks 26, 52, 78, 104, 130 and 156.

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 per month, 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