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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Nonoxynol-9 100 mg gel: Multi-site safety study from sub-Saharan Africa
AIDS, Volume 18, No. 16, Year 2004
Notification
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Description
Objectives: To evaluate the safety of 100mg nonoxynol-9 (N-9) gel, a vaginal microbicide, on the genital mucosa of women from Malawi and Zimbabwe in preparation for a phase III efficacy study. Methods: HIV-uninfected women (180) were enrolled and randomized to either N-9 or placebo gel and instructed to insert gel into the vagina twice daily for 14 days. Follow up examinations were conducted at 7 and 14 days. Results: The number of adverse events in the N-9 gel group was higher than in the placebo group (40% versus 13%; P<0.01). Reported number of any genital symptoms was significantly higher in the N-9 group (38% N-9, 13% placebo; P = 0.01). The number of total epithelial disruptions was higher in the N-9 group (20% versus 3%; P< 0.01); however, the number of genital ulcers and abrasions in the N-9 group was low (2% and 3%, respectively) and not different from that in the placebo group (1% and 2%, respectively). Conclusions: N-9 gel 100 mg caused a significant increase in the rate of genital symptoms and epithelial disruptions compared with placebo. The clinical significance of these epithelial disruptions is unknown. Although these findings alone were not sufficient to cancel the planned phase III study, when considered together with the negative results from the COL-1492 effectiveness trial of 52.5 mg N-9 gel, the decision was made to cancel the planned phase III trial of 100 mg N-9 gel. © 2004 Lippincott Williams & Wilkins.
Authors & Co-Authors
Hoffman, Irving F.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Malawi, Lilongwe
Unc Project-malawi
Taha, Taha E.
United States, Baltimore
Johns Hopkins University
Padian, Nancy S.
United States, San Francisco
University of California, San Francisco
Kelly, Clifton W.
United States, Seattle
Fred Hutchinson Cancer Research Center
Welch, Julia D.
United States, Durham
Fhi 360
Martinson, Francis E.A.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Malawi, Lilongwe
Unc Project-malawi
Kumwenda, Newton I.
United States, Baltimore
Johns Hopkins University
Rosenberg, Zeda F.
United States, Washington, D.c.
Intl. Partnership for Microbicides
Chilongozi, David A.T.
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Malawi, Lilongwe
Unc Project-malawi
Brown, Joelle Morgan
United States, San Francisco
University of California, San Francisco
Chirenje, Mike Zvavahera
Zimbabwe, Harare
University of Zimbabwe
Richardson, Barbra Ann
United States, Seattle
Fred Hutchinson Cancer Research Center
United States, Seattle
University of Washington
Statistics
Citations: 12
Authors: 12
Affiliations: 9
Identifiers
Doi:
10.1097/00002030-200411050-00012
Research Areas
Infectious Diseases
Sexual And Reproductive Health
Study Locations
Malawi
Zimbabwe
Participants Gender
Female