NIH funds HIV microbicide study
This article was originally published in The Tan Sheet
Executive Summary
A National Institutes of Health-funded study on the safety of its vaginal microbicide gel VivaGel (SPL7013) has begun, Starpharma Holdings announces July 10. The gel, intended to be used for the prevention of HIV and genital herpes, is being tested in 40 sexually active, HIV-negative women aged 18 to 24 for its safety, acceptability and ease of use at the University of South Florida in Tampa and the University of Puerto Rico in San Juan. Starpharma says it expects the product will ultimately be OTC, but in some markets it may be initially offered by prescription. In 2005 NIH funded a study on Indevus Pharmaceuticals' microbicide PRO 2000 (1"The Tan Sheet" Feb. 14, 2005, In Brief)...
You may also be interested in...
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)...
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.