The National Institute of Allergy and Infectious Diseases (NIAID) is set to close out the HPTN 058 study, a Phase III clinical trial that started in 2007 and was tasked with evaluating whether or not administering opiate dependence medication, combined with drug and HIV risk-reduction counseling, can prevent HIV infection and death among opiate-dependent injection drug users. After reviewing available study data, an independent data and safety monitoring board (DSMB) made the recommendation to end the study after discovering that the trial will be unable to achieve its “primary objectives,” according to an NIAID press release.
Along with providing behavioral interventions, researchers administered a medication containing buprenorphine and naloxone, an approved treatment for opiate dependence, to opiate-dependent, HIV-uninfected adults at four sites in China and Thailand. Half of the 1,250 study participants were randomly assigned to receive long-term treatment: the medication taken daily for up to 21 days, followed by taking the drug three times a week for 52 weeks. The other participants were randomly assigned to receive short-term treatment: the same dual-drug therapy taken daily for approximately three weeks. Participants in both groups received weekly drug and HIV risk-reduction counseling for three months, followed by counseling sessions every four weeks for up to one year.
The study was designed to test whether long-term medication treatment plus counseling is more effective than short-term treatment and counseling in reducing the incidence of HIV infection and deaths among participants. After reviewing the study data, the DSMB found that the number of HIV infections and deaths among participants were lower than expected and concluded the study would be unable to demonstrate a difference between the two treatment groups.
Participants will gradually be moved off the study, and those who became infected with HIV during the study were referred to local health centers for HIV treatment and care, according to the national guidelines in China and Thailand, where antiretroviral therapy is readily available.
To learn more about the study, click here.