Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

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