NCT00270257|TerminatedPhase 3ResultsDMC
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DSMB halted the study due to futility as a result of lower than anticipated HIV incidence rates
A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors
Sponsor study identifier
Secondary identifiers
REGISTRY · DAIDS ES
interventional
1,251
2 countries
4
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2005
Actual (reported)December 26, 2005
Actual (reported)May 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 2012
Actual (reported)July 2012
Actual (reported)December 8, 2016
Actual (reported)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
Number of Participants With Urinalysis Results Positive for Opiates
Measured through Week 104
Self-report of Continued Injection Opiate Use in the Last 30 Days
Measured through Week 104
Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months
Measured through Week 104
Self-reported Number of Injections in the Last Month
Measured through Week 104
Incident Hepatitis C Infections for Thailand and China
Measured through week 156 in Thailand and 104 weeks in China
Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52
Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.
Oral tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Buprenorphine/Naloxone
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHeng County Ctr. for Disease Control & Prevention CRS
Hengzhou Town, Guangxi, 530300, China
Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS
Nanning, Guangxi, 530028, China
Xinjiang CRS
Ürümqi, Xinjiang, 830011, China
CMU HIV Prevention CRS
Chiang Mai, 50200, 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. doi: 10.1097/00002030-200411190-00010.
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. doi: 10.1002/14651858.CD004145.pub2.
David Metzger, PhD
Center for Studies of Addiction, University of Pennsylvania
1,251 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
A Study of Peer Education to Prevent HIV Transmission Among Injection Drug Users and Their HIV Risk Contacts
Contact the study team to confirm eligibility.
Koester S, Glanz J, Baron A. Drug sharing among heroin networks: implications for HIV and hepatitis B and C prevention. AIDS Behav. 2005 Mar;9(1):27-39. doi: 10.1007/s10461-005-1679-y.
Raisch DW, Fye CL, Boardman KD, Sather MR. Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother. 2002 Feb;36(2):312-21. doi: 10.1345/aph.10421.
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. doi: 10.1097/01.qai.0000152398.47025.0f.
Lucas GM, Beauchamp G, Aramrattana A, Shao Y, Liu W, Fu L, Jackson JB, Celentano DD, Richardson P, Metzger D; HPTN 058 study group. Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. Int J Drug Policy. 2012 Mar;23(2):162-5. doi: 10.1016/j.drugpo.2011.06.005. Epub 2011 Aug 17.
Sugarman J, Corneli A, Donnell D, Liu TY, Rose S, Celentano D, Jackson B, Aramrattana A, Wei L, Shao Y, Liping F, Baoling R, Dye B, Metzger D. Are there adverse consequences of quizzing during informed consent for HIV research? J Med Ethics. 2011 Nov;37(11):693-7. doi: 10.1136/jme.2011.042358. Epub 2011 Jun 8.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
November 5, 2021
Results First Posted
December 8, 2016
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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