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

Study Summary
Study Documents - Study Details* - Key Study Personnel* - Study SitesPublications
*Authenticated users only (create your account here)

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.