HIV Infections Clinical Trial
Official title:
A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors
NCT number | NCT00270257 |
Other study ID # | HPTN 058 |
Secondary ID | 10144 |
Status | Terminated |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | July 2012 |
Verified date | December 2016 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1251 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Heng County Ctr. for Disease Control & Prevention CRS | Hengzhou Town | Guangxi |
China | Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS | Nanning | Guangxi |
China | Xinjiang CRS | Urumqi | Xinjiang |
Thailand | CMU HIV Prevention CRS | Chiang Mai |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | National Institute on Drug Abuse (NIDA) |
China, Thailand,
Aceijas C, Stimson GV, Hickman M, Rhodes T; United Nations Reference Group on HIV/AIDS Prevention and Care among IDU in Developing and Transitional Countries. Global overview of injecting drug use and HIV infection among injecting drug users. AIDS. 2004 Nov 19;18(17):2295-303. — View Citation
Gowing L, Farrell M, Bornemann R, Ali R. Substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004145. Review. Update in: Cochrane Database Syst Rev. 2008;(2):CD004145. — View Citation
Koester S, Glanz J, Barón A. Drug sharing among heroin networks: implications for HIV and hepatitis B and C prevention. AIDS Behav. 2005 Mar;9(1):27-39. — View Citation
Raisch DW, Fye CL, Boardman KD, Sather MR. Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother. 2002 Feb;36(2):312-21. Review. — View Citation
Ruan Y, Qin G, Liu S, Qian H, Zhang L, Zhou F, He Y, Chen K, Yin L, Chen X, Hao Q, Xing H, Song Y, Wang Y, Hong K, Chen J, Shao Y. HIV incidence and factors contributed to retention in a 12-month follow-up study of injection drug users in Sichuan Province, China. J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):459-63. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks | The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect. | For visits up to week 104 | |
Secondary | Number of Participants With Urinalysis Results Positive for Opiates | Urine drug screen were assessed monthly and semiannually. | Measured through Week 104 | |
Secondary | Self-report of Continued Injection Opiate Use in the Last 30 Days | All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits. | Measured through Week 104 | |
Secondary | Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months | Measured through Week 104 | ||
Secondary | Self-reported Number of Injections in the Last Month | Measured through Week 104 | ||
Secondary | Incident Hepatitis C Infections for Thailand and China | HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.
If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint). Analysis was done separately for both countries |
Measured through week 156 in Thailand and 104 weeks in China | |
Secondary | Incident Hepatitis B Infections | Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg. | Measured through week 52 |
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