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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission
New England Journal of Medicine, Volume 359, No. 5, Year 2008
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Description
Background: Women make up more than 50% of adults living with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa. Thus, female-initiated HIV prevention methods are urgently needed. Methods: We performed a randomized, double-blind, placebo-controlled trial of cellulose sulfate, an HIV-entry inhibitor formulated as a vaginal gel, involving women at high risk for HIV infection at three African and two Indian sites. The primary end point was newly acquired infection with HIV type 1 or 2. The secondary end point was newly acquired gonococcal or chlamydial infection. The primary analysis was based on a log-rank test of no difference in the distribution of time to HIV infection, stratified according to site. Results: A total of 1398 women were enrolled and randomly assigned to receive cellulose sulfate gel (706 participants) or placebo (692 participants) and had follow-up HIV test data. There were 41 newly acquired HIV infections, 25 in the cellulose sulfate group and 16 in the placebo group, with an estimated hazard ratio of infection for the cellulose sulfate group of 1.61 (P = 0.13). This result, which is not significant, is in contrast to the interim finding that led to the trial being stopped prematurely (hazard ratio, 2.23; P = 0.02) and the suggestive result of a preplanned secondary (adherence-based) analysis (hazard ratio, 2.02; P = 0.05). No significant effect of cellulose sulfate as compared with placebo was found on the risk of gonorrheal infection (hazard ratio, 1.10; 95% confidence interval [CI], 0.74 to 1.62) or chlamydial infection (hazard ratio, 0.71; 95% CI, 0.47 to 1.08). Conclusions: Cellulose sulfate did not prevent HIV infection and may have increased the risk of HIV acquisition. (ClinicalTrials.gov number, NCT00153777; and Current Controlled Trials number, ISRCTN95638385.) Copyright © 2008 Massachusetts Medical Society. All rights reserved.
Authors & Co-Authors
van Damme, Lut
United States, Arlington
Conrad
United States, Durham
Fhi 360
Govinden, Roshini
South Africa, Tygerberg
South African Medical Research Council
Mirembe, Florence Maureen
Uganda, Kampala
Makerere University
Guédou, Fernand Aimé
Canada, Quebec
Chu de Québec-université Laval
Solomon, Suniti S.
India, Chennai
Yr Gaitonde Centre for Aids Research and Education
Becker, Marissa L.
Canada, Winnipeg
University of Manitoba
Pradeep, Banandur S.
India, Bengaluru
St. John's Medical College
Krishnan, A. K.
India, Chennai
Yr Gaitonde Centre for Aids Research and Education
Alary, Michel
Canada, Quebec
Chu de Québec-université Laval
Pande, Bina
Uganda, Kampala
Makerere University
Ramjee, Gita A.
South Africa, Tygerberg
South African Medical Research Council
Deese, Jennifer
United States, Durham
Fhi 360
Crucitti, Tania
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Taylor, Douglas J.
United States, Durham
Fhi 360
Statistics
Citations: 449
Authors: 14
Affiliations: 9
Identifiers
Doi:
10.1056/NEJMoa0707957
ISSN:
00284793
e-ISSN:
15334406
Research Areas
Disability
Environmental
Infectious Diseases
Study Design
Cohort Study
Participants Gender
Female