Food and Drug Administration - November 4, 2005
Richard Klein

The "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection" has been updated. The new version includes:

1. Information about the recently approved protease inhibitor tipranavir and information about new formulations of emtricitabine and lopinavir/ritonavir.

2. A fully revised and updated Supplement I: Characteristics of Available Antiretroviral Drugs.

3. Updated information on hepatotoxicity in Supplement III: Adverse Drug Effects.

4. A Pediatric Antiretroviral Guidelines Working Group Conflict of Interest Disclosure (Appendix B).

The updated guidelines documents are available in the PEDIATRIC GUIDELINES section of the GUIDELINES page on the AIDSinfo Web site (http://aidsinfo.nih.gov/guidelines/default_db2.asp?id=51).

All new information in the main document, Appendix A, and Supplement III is highlighted.

Appendix B is new and Supplement I has been entirely rewritten, so these sections are highlighted in title only.

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You can download the guidelines or can request to receive them by e-mail or hard copy on the AIDSinfo Web site.

The AIDSinfo website is also a useful source of other information related to HIV/AIDS, including other treatment and prevention guidelines, downloadable databases for PDAs (Personal Digital Assistants), and HIV/AIDS-related clinical trials information.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

051104
FD051102

SOURCE: Food and Drug Administration (FDA).

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