skip to content


Issue No. 46 | October 21, 2011

News and Features

HPTN 058 HIV Prevention Study Among Injection Drug Users Will Close Early

“HPTN 058, a Phase III clinical trial evaluating whether medication combined with drug and HIV risk-reduction counseling can prevent HIV infection and death among opiate-dependent injection drug users, will cease new enrollment and begin a phased close out. The actions are being taken after an independent data and safety monitoring board (DSMB) recently concluded that based on available study data, the trial will be unable to achieve its primary objectives. The DSMB, therefore, recommended that the study end. … 

“Injection drug use has long been recognized as a major risk factor for HIV infection. … HPTN 058 was examining the effectiveness of a medication containing buprenorphrine and naloxone, an approved treatment for opiate dependence, in combination with a behavioral intervention as an approach for reducing HIV acquisition among those who inject illicit opiates, such as heroin. …

“The study was primarily designed to test whether long-term medication treatment plus drug and HIV risk-reduction counseling worked better than short-term treatment and counseling in reducing the cumulative incidence of HIV infection and deaths among the study participants when evaluated 104 weeks after enrollment. Based on the DSMB’s scheduled interim review of the study data, however, the numbers of HIV infections and deaths among study participants were lower than expected and, therefore, the DSMB determined that the study would be unable to demonstrate a difference between the two treatment groups. However, the DSMB noted that the clinical trial will be able to achieve important secondary objectives, including determining whether long-term treatment is better than short-term treatment in reducing the frequency of HIV risk-taking behaviors … .

“For more information, visit the HPTN 058 study page.”

More information is available:

Study Shows How Tenofovir Vaginal Gel May Block the Genital Herpes Virus

“An anti-HIV drug also discovered to stop the spread of the genital herpes virus does so by disabling a key DNA enzyme of the herpes virus, according to findings by researchers at the National Institutes of Health and other institutions. …

“The findings explain the results of a recent clinical trial showing that the anti-HIV drug tenofovir, when it is formulated as a vaginal gel, could reduce the risk of herpes simplex virus (HSV) infections — as well as HIV infections — in women.

“Tenofovir taken orally had been demonstrated to inhibit reproduction of HIV, but had not been known to block the genital herpes virus.

“‘HIV infection is closely associated with herpes viral infection. When people with genital herpes are exposed to HIV, they are more likely to become infected than are people who do not carry the herpes virus,’ said Leonid Margolis, Ph.D., head of the Section on Intercellular Interactions at NICHD and one of the authors of the study. ‘Human tissues convert tenofovir to a form that suppresses HIV. We found that this form of tenofovir also suppresses HSV. This discovery may help to identify drugs to treat the two viruses even more effectively.’ …

“Tenofovir is converted by cellular enzymes to another chemical form. The researchers found that this form of tenofovir suppresses not only HIV, but HSV as well. Specifically, the researchers showed that this active form of tenofovir can disable an enzyme that the virus needs to reproduce. …

“The vaginal gel showed activity against HSV apparently because of the high concentration of tenofovir that it contains. In contrast, when tenofovir is taken orally, tissue levels do not reach sufficient levels to significantly affect HSV.”

More information is available:

New Research Published on the Optimal Time to Begin HIV Treatment for People with HIV and TB

On October 20, 2011, NIAID released the following message:

“Severely immunocompromised patients who are infected with both HIV and tuberculosis (TB) and who have never been treated for HIV should start therapy for the virus as soon as possible after beginning TB treatment, according to two newly published papers in the New England Journal of Medicine
“With NIAID support, the studies addressed the dilemma that starting treatment for HIV before a patient’s TB disease is under control can lead to severe illness or death from immune reconstitution inflammatory syndrome (IRIS), but starting HIV treatment too late may allow the patient to die from HIV infection. The studies found that even though IRIS occurred more often in patients who were treated for HIV early, more of the sickest patients receiving early HIV treatment survived compared to those who started treatment later. 

“TB is the leading cause of death for people with HIV, accounting for 400,000 HIV-related deaths worldwide in 2009 alone.”

More information is available: