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NIH microbicide trial

This article was originally published in The Tan Sheet

Executive Summary

The National Institute of Allergy & Infectious Diseases will fund a trial evaluating the safety and efficacy of Indevus Pharmaceuticals' topical microbicide PRO 2000, the firm announces Feb. 11. The study is expected to include 3,220 women recruited from five African countries - Malawi, South Africa, Tanzania, Zambia and Zimbabwe - and has an expected duration of 30 months. Participants will be placed into four equally sized groups and receive either PRO 2000, a second microbicide, a placebo gel or no gel. All participants also will receive condoms and prevention counseling during visits to the participating clinics. Study authors will "evaluate the effectiveness of the candidate microbicides in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia," Indevus says, noting PRO 2000 is still in development. Panelists at an FDA Antiviral Drugs Advisory Committee meeting recommended a three-armed trial to study microbicides' net benefit (1"The Tan Sheet" Aug. 25, 2003, p. 7)...

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