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)...
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)...
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)...