HPTN 058
A Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors
What is HPTN 058?Since the AIDS epidemic among injection drug users (IDUs) was first recognized in the early 1980s, a variety of prevention interventions have targeted IDUs. No intervention, however, has been as widely endorsed, nor as thoroughly examined as substance abuse treatment, specifically methadone treatment. Studies conducted in Australia, Europe, and the United States over the past 17 years have, with few exceptions, found associations between participation in substance abuse treatments and reductions in HIV risk behaviors, lower HIV prevalence and lower HIV incidence rates. There is a need to examine this strategy directly and the HPTN is in a unique position to conduct such a trial and advance the scientific understanding of HIV prevention among drug using individuals.
The use of buprenorphine/naloxone for the treatment of opiate dependence offers an effective drug treatment that may be a more acceptable alternative to methadone in treating opiate dependence and potentially reducing HIV transmission among heroin injectors. HPTN 058 is a Phase III randomized controlled trial that will assess the efficacy of buprenorphine/naloxone treatment in the prevention of HIV transmission among opiate dependent injectors by reducing drug use and associated risk behaviors. A total of 1460 opiate dependent injectors, 18 or more years of age and HIV uninfected, will be enrolled in this study. One treatment group will receive buprenorphine/naloxone for one year; the other treatment group will receive detoxification for up to 18 days, with a second detoxification possible if required. Both treatment groups will receive the same intensive drug- and risk-reduction counseling for one year. |
Protocol Status: Enrolling
Study Purpose: To determine the efficacy of a drug treatment intervention involving administration of a buprenorphine/naloxone (BUP/NX) combination for 52 weeks plus drug and risk-reduction counseling (hereafter referred to as "substitution treatment") compared with short-term detoxification with BUP/NX plus drug and risk-reduction counseling (hereafter referred to as "detoxification treatment") for the prevention of HIV transmission and death among opiate dependent injectors by reducing drug use and associated risk behavior.
Study Design: This is a Phase III, multi-site, two-arm, open-label, randomized, controlled trial. An initial safety and feasibility phase will include the first 50 study participants at each site.
Study Population: Participans will be HIV-uninfected, opiate dependent injection drug users who meet the eligibility criteria will be recruited from the community.
Study Size: A total of 1500 opiate dependent injectors will be enrolled.
Study Duration: Approximately 5 years; each participant followed for 2-3 years.
Treatment Regimen: Substitution Arm: Sublingual BUP/NX daily up to 21 days (until dose stabilization) and then three times per week for 52 weeks; plus weekly individual drug- and risk-reduction counseling for twelve weeks, followed thereafter by monthly counseling sessions every four weeks through week 52. Detoxification Arm: Short-term detoxification with sublingual BUP/NX for 18 days maximum with a second detoxification possible at week 26; plus weekly individual drug- and risk-reduction counseling for twelve weeks, followed thereafter by monthly counseling sessions every four weeks through week 52.
Primary Objectives: To determine whether 52 weeks of substitution BUP/NX and counseling treatment in opiate addicted participants will achieve a long term (104 weeks) reduction in cumulative HIV incidence and death compared to short-term BUP/NX detoxification and counseling.
Secondary Objectives: 1.To determine if the substitution treatment reduces average HIV incidence and death compared to the detoxification arm; and reduces HIV incidence and death at 52 weeks and 156 weeks. 2.To determine if substitution treatment decreases average HIV incidence compared to detoxification treatment; and HIV incidence at 52, 104, and 156 weeks. 3.To compare the average rates of death in the two arms; and the rates of death at 52, 104, and 156 weeks. 4.To compare the self-reported frequency of injection, drug and sex-related HIV risk behaviors in the two study arms. 5.To compare the frequency of drug use measured by self-report and urinalysis in the two arms.
SDMC Protocol Specialist: Huguette Redinger get info
Protocol Team Member: Bariatu Smith get info
Protocol Team Member: Lynnea Ladouceur get info
Protocol Statistician: Deborah Donnell get info
Protocol Co-Chair: Apinun Aramrattana get info
Protocol Co-Chair: David Celentano get info
Protocol Co-Chair: J. Brooks Jackson get info
Protocol Co-Chair: Yiming Shao get info
Protocol Chair: David Metzger get info
DAIDS Medical Officer: David Burns get info
CORE Protocol Specialist: Bonnie Dye get info
CORE Protocol Specialist: Philip Andrew get info
CORE Protocol Specialist: Scott Rose get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
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Heng County Center for Disease Control and Prevention 30277 Hengzhou Town, China |
405 across both Guangxi sites |
87 participants enrolled |
Enrolling |
get more |
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31485 Kunming, China |
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get more |
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30274 Nanning, China |
405 across both Guangxi sites |
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Registered |
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Xinjiang Autonomous Region Center for Disease Control and Prevention
Urumqi, China |
495 across both Xinjiang sites |
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Designated |
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31484 Urumqi, China |
495 |
127 participants enrolled |
Enrolling |
get more |
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Chiang Mai Univ. AIDS Prevention CRS 31458 Chiang Mai, Thailand |
305 across all Chiang Mai sites |
171 participants across all Chiang Mai sites |
Enrolling |
get more |
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Chiang Mai University, Faculty of Medicine, Department of Family Medicine
Chiang Mai, Thailand |
305 across all Chiang Mai sites |
|
Enrolling |
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Chiang Mai University, Faculty of Medicine, Department of Psychiatry
Chiang Mai, Thailand |
305 across all Chiang Mai sites |
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Enrolling |
get more |
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Chiang Mai, Thailand |
305 across all Chiang Mai sites |
|
Enrolling |
get more |
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Chiang Mai, Thailand |
305 across all Chiang Mai sites |
|
Enrolling |
get more |
