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Study
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HPTN 058
A Phase III randomized
controlled trial to evaluate the efficacy of drug treatment in prevention of HIV
infection among opiate dependent injectors
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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.
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Protocol Status:
Enrolling
Study
Summary
Study Purpose: The purpose of the study is to determine the efficacy of a drug treatment intervention (buprenorphine/naloxone) in the prevention of HIV transmission among opiate dependent injectors by reducing drug use and associated risk behaviors.
Study Design: This will be a Phase III, randomized, two-arm trial comparing longer term (12 months) drug treatment with Suboxone plus counseling to short-term (<19 days) detoxification with Suboxone plus counseling. A second opportunity for detoxification will be offered to those who meet criteria at month six. A feasibility study will be conducted with the first 50 participants in each of the sites.
Study Population: Participants will be HIV-uninfected opiate dependent injectors recruited from the community and from drug treatment facilities. All subjects will be at least 18 years of age.
Study Size: A total of 1460 opiate dependent injectors will be enrolled.
Study Duration: Approximately 5 years; each participant followed for 2-3 years.
Treatment Regimen: Substitution Arm: Sublingual buprenorphine/naloxone (Suboxone) three times per week for 12 months. In addition, weekly counseling sessions for first three months focusing on controlling drug use and HIV prevention skills. During months four through twelve, counseling sessions will occur on a monthly basis.
Detoxification Arm: A maximum of 18 days of sublingual buprenorphine/naloxone (Suboxone) detoxification. Three months of weekly individual drug and risk reduction counseling focused on strategies for controlling drug use and HIV prevention skills. During months four through twelve, counseling sessions will occur on a monthly basis. A second opportunity for detoxification will be offered at six months to those who qualify.
Primary Objectives: To determine whether 52 weeks of Suboxone and counseling treatment in opiate addicted participants will achieve a long term (104 weeks) reduction in cumulative HIV incidence compared to short-term Suboxone detoxification and counseling.
Secondary Objectives: 1.To determine if the substitution treatment reduces average HIV incidence compared to the detoxification arm; and reduces HIV incidence at 52 weeks and 156 weeks.
2.To determine if substitution treatment increases average HIV-free survival compared to detoxification treatment; and HIV-free survival 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
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Protocol Team Member:
Bariatu Smith
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Protocol Team Member:
Lynnea Ladouceur
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Protocol Co-Chair:
David DuPuy Celentano
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Protocol Co-Chair:
J. Brooks Jackson
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Protocol Chair:
David Metzger
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DAIDS Medical Officer:
David Burns
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CORE Protocol Specialist:
Bonnie Dye
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CORE Protocol Specialist:
Scott Rose
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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 |
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Registered |
get more |
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Yunnan Clinical Research Site
31485
Kunming,
China |
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De-Registered |
get more |
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Guangxi Centers for Disease Control and Prevention, Guangxi Center for HIV/AIDS Prevention and Control
30274
Nanning,
China |
405 across both Guangxi sites |
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Registered |
get more |
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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 |
get more |
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Xinjiang Uygar Autonomous Region Center for Disease Control and Prevention, HPTN Project Office
Urumqi,
China |
495 |
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Designated |
get more |
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Chiang Mai Univ. AIDS Prevention CRS
31458
Chiang Mai,
Thailand |
305 across all Chiang Mai sites |
69 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 |
get more |
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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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Fa Mai Clinic
Chiang Mai,
Thailand |
305 across all Chiang Mai sites |
|
Enrolling |
get more |
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PEN House
Chiang Mai,
Thailand |
305 across all Chiang Mai sites |
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Enrolling |
get more |
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