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: Participants Off Study & Primary Analysis Complete

Study Summary

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 "long-term medication assisted treatment") compared with short-term medication assisted treatment with BUP/NX plus drug and risk-reduction counseling (hereafter referred to as "short-term medication assisted 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: Long-term Medication Assisted Treatment 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. Vs. Short-term Medication Assisted Treatment Arm: Sublingual BUP/NX for 18 days maximum with a second short-term medication assisted treatment 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 long-term medication assisted treatment with 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 medication assisted treatment and counseling.


SDMC Protocol Specialist: Huguette Redinger get info

Protocol Team Member: Bariatu Smith 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: Kevin Bokoch get info

CORE Protocol Specialist: Scott Rose get info

Site Target
Enrollment
Cumulative
Enrollment
Implementation
Status
More
Info

Heng County Ctr. for Disease Control & Prevention CRS

30277

Hengzhou Town, China

405

411

Closed to Follow Up

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Guangxi Ctrs. for Disease Control & Prevention/ Guangxi Ctr. for HIV/AIDS Prevention & Control CRS

30274

Nanning, China

455

161

Closed to Follow Up

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Xinjiang Uygar Autonomous Region Center for Disease Control and Prevention, HPTN Project Office (Xinjiang CRS)

31484

Urumqi, China

495 across both sites

478across both sites

Closed to Follow Up

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Chiang Mai Univ. AIDS Prevention CRS

31458

Chiang Mai, Thailand

enrollment closed at 202

202 participants across all Chiang Mai sites

Closed to Follow Up

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Chiang Mai University, Faculty of Medicine, Department of Family Medicine

30263

Chiang Mai, Thailand

305 across all Chiang Mai sites

 

Closed to Follow Up

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Chiang Mai University, Faculty of Medicine, Department of Psychiatry

 

Chiang Mai, Thailand

305 across all Chiang Mai sites

281

Closed to Follow Up

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Fa Mai Clinic

 

Chiang Mai, Thailand

305 across all Chiang Mai sites

 

Closed to Follow Up

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PEN House

 

Chiang Mai, Thailand

305 across all Chiang Mai sites

 

Closed to Follow Up

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HPTN 058 Publications

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, 37: 693-7 PMCID: 3200567

Lucas GM, Beauchamp G, Aramrattana A, Shao Y, Liu W, Fu L, Jackson JB, Celentano DD, Richardson P, Metzger D; for the 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, 23: 162-5 PMCID: 3236277

Sugarman J, Rose SM, Metzger D. Ethical issues in HIV prevention research with people who inject drugs. Clin Trials. 2013, 11: 239-45 PMCID: 3972281

Jackson JB, Wei L, Liping F, Aramrattana A, Celentano DD, Walshe L, Xing Y, Richardson P, Jun M, Beauchamp G, Donnell D, Ruan Y, Ma L, Metzger D, Shao Y. Prevalence and seroincidence of hepatitis B and hepatitis C infection in high risk people who inject drugs in china and Thailand. Hepat Res Treat. 2014, 2014: Epub PMCID: 3985324

Sugarman J, Rose SM, Metzger D. Ethical issues in HIV prevention research with people who inject drugs. Clin Trials. 2014, 11: 239-45 PMCID: 3972281