Status:
TERMINATED
Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Opioid-Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 effec...
Detailed Description
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
1251 Patients enrolled
Trial Details
Trial ID
NCT00270257
Start Date
May 1 2008
End Date
July 1 2012
Last Update
November 5 2021
Active Locations (4)
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1
Heng County Ctr. for Disease Control & Prevention CRS
Hengzhou Town, Guangxi, China, 530300
2
Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS
Nanning, Guangxi, China, 530028
3
Xinjiang CRS
Ürümqi, Xinjiang, China, 830011
4
CMU HIV Prevention CRS
Chiang Mai, Thailand, 50200