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 was HPTN 058?
A Phase III, multi-site, two-arm, open-label, randomized, controlled trial to evaluate the efficacy of treatment for opiate dependence as an intervention to prevent HIV infection and death among injection drug users.
Who participated in the study?
1,500 opiate dependent, HIV-uninfected injectors
What happened during the study?
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.
Results
After analyzing the data currently available, the DSMB determined that the study would not be able to demonstrate a difference between the two treatment groups. However, the study was able to address a number of important secondary objectives. Analysis of data from HPTN 058 provided much needed new information on promising approaches for HIV prevention among injection drug users.
Why was this study important?
Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research.
Study Documents
HPTN 058 Version 2.0
- HPTN 058 Protocol V2.0 - English
- Summary of Changes V2.0
- HPTN 058 Protocol V2.0 - Chinese
- HPTN 058 Protocol V2.0 - Vietnamese
- HPTN 058 v 2.0 LoA #3 19 Jul 2011 (Chinese PDF)
- HPTN 058 v 2.0 LoA #3 19 Jul 2011 (English PDF)
- HPTN 058 v 2.0 LoA #2, 24 Mar 2011 (PDF)
- HPTN 058 v 2.0 LoA #2, 24 Mar 2011 Chinese (PDF)
- HPTN 058 v 2.0 LoA #1, 25 Sep 2009 (PDF)
- HPTN 058 v 2.0 LoA #1, 25 Sep 2009 Vietnamese (PDF)
- HPTN 058 v 2.0 LoA #1, 25 Sep 2009 Chinese (PDF) revised
HPTN 058 Version 1.0
Study Details
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.
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.
Participans will be HIV-uninfected, opiate dependent injection drug users who meet the eligibility criteria will be recruited from the community.
A total of 1500 opiate dependent injectors will be enrolled.
Approximately 5 years; each participant followed for 2-3 years.
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.
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.