• Evidence of HIV-1 infection or death [ 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 ]
  
• HIV-1 infection every six months at scheduled study follow-up visits [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  
• Mortality [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  

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 30 weeks. Study visits will occur every week and will include a physical exam and blood and urine collection.

The main treatment phase of the study will last 52 weeks. Participants in Group 1 will receive BUP/NX under the tongue, at first daily and then three times a week for 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 in Group 2 will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator. 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, participants in both groups will attend 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.