FDA Notifications

FDA issues guidance about HIV vaccine study

The FDA is issuing guidance to sponsors on initiation of HIV vaccine studies involving pediatric patients. The guidance also provides recommendations to investigators and institutional review boards (IRBs) involved with such studies.

This guidance specifically addresses issues regarding development of a preventive HIV vaccine for use in healthy U.S. pediatric populations.

The guidance is available on the FDA web site at www.fda.gov/cber/gdlns/pedhiv.htm. Copies are also available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 or by calling 1-800-835-4709 or 301-827-1800.

Written comments on this guidance may be submitted at any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. You should identify all comments with the title of this guidance: "Development of Preventive HIV Vaccines for Use in Pediatric Populations."

HIV-1 adult treatment guidelines are updated

"The Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents" has been revised to include new recommendations for resistance testing, treatment interruption, and HBV/HIV co-infection. Tables have been revised to include up-to-date information about drug interactions and about the lopinavir/ritonavir 200/50 mg tablet formulation.

Changes to the document are summarized in the "What's New in the Document?" section, and all changes to the document are highlighted in yellow throughout the text.

The updated guidelines document is available in the adult guidelines section of the guidelines page on the www.AIDSinfo.nih.gov web site. The site also contains an option to order hard copies of the guidelines or request an electronic copy by e-mail.

Two tenofovir containing products approved

On March 8, 2006, the FDA granted traditional approval to two tenofovir DF containing products manufactured by Gilead Sciences, tenofovir disoproxil fumarate (Viread) and fixed dose combination of tenofovir DF and emtricitabine (Truvada). Both products are indicated for the treatment of HIV in combination with other antiretroviral drugs.

Both products had received accelerated approval on Oct. 26, 2001 and August 2, 2004, respectively. Traditional approval is supported by previously submitted studies and the recently submitted Study 934, which compared the antiviral activity of tenofovir DF, emtricitabine, and efavirenz to zidovudine, lamivudine and efavirenz in treatment of naïve HIV-infected individuals receiving these regimens through 48 weeks.