Microbicide Trial Three-Arm Design May Be Optimal Initially – Panelists
This article was originally published in The Tan Sheet
Executive Summary
A microbicide clinical trial "win" should be based on "compelling" evidence of superior efficacy versus placebo and "supportive" evidence compared with a no-treatment arm, FDA Antiviral Drugs Advisory Committee consultant Richard Haubrich, MD, University of California, San Diego, said at an Aug. 20 meeting of the panel
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NIH microbicide trial
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)...
FDA microbicide meeting
Design of antimicrobial clinical trials will be discussed at an April 15-16 meeting sponsored by FDA and the Infectious Diseases Society of America, agency announces in Federal Register March 9. The public workshop will include input from interested groups on trial endpoints, drug development. Topics mirror those covered at a mid-2003 meeting of the FDA Antiviral Drugs Advisory Committee (1"The Tan Sheet" Aug. 25, 2003, p. 7). Meeting will take place at the Center for Drug Evaluation & Research, 5630 Fishers Lane, Rockville, Md...
Microbicide Trial “Condom Only”-Arm Designs To Be Reviewed By FDA Cmte.
FDA is seeking guidance from the Antiviral Drugs Advisory Committee as to whether clinical trials on topical microbicides should include a "no treatment" (condom only) arm