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Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission

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dc.contributor.author Van Damme, L. en_US
dc.contributor.author Govinden, R. en_US
dc.contributor.author Mirembe, F. M. en_US
dc.contributor.author Guédou, F. en_US
dc.contributor.author Solomon, S. en_US
dc.contributor.author Becker, M. L. en_US
dc.contributor.author Pradeep, B. S. en_US
dc.contributor.author Krishnan, A. K. en_US
dc.contributor.author Alary, M. en_US
dc.contributor.author Pande, B. en_US
dc.contributor.author Ramjee, G. en_US
dc.contributor.author Deese, J. en_US
dc.contributor.author Crucitti, T. en_US
dc.contributor.author Taylor, D. en_US
dc.date.accessioned 2008-09-17T15:08:03Z
dc.date.available 2008-09-17T15:08:03Z
dc.date.issued 2008
dc.identifier.issn 0028-4793
dc.identifier.other ITG-M13A en_US
dc.identifier.other MICRO en_US
dc.identifier.other U-HIVSTD en_US
dc.identifier.other JIF en_US
dc.identifier.other UPD6 en_US
dc.identifier.other ABSTRACT en_US
dc.identifier.other FTA en_US
dc.identifier.uri http://hdl.handle.net/10390/2364
dc.description.abstract 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.) en_US
dc.language English en_US
dc.publisher Massachusetts Medical Society en_US
dc.subject Viral diseases en_US
dc.subject HIV en_US
dc.subject AIDS en_US
dc.subject Transmission prevention en_US
dc.subject Microbicides en_US
dc.subject Cellulose sulfate en_US
dc.subject Effectiveness en_US
dc.subject Evaluation en_US
dc.subject Randomized controlled trials en_US
dc.title Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission en_US
dc.type Article en_US
dc.citation.issue 5 en_US
dc.citation.jtitle New England Journal of Medicine en_US
dc.citation.volume 359 en_US
dc.citation.pages 463-472 en_US
dc.publisher.place Waltham en_US
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/18669425
dc.citation.jabbreviation N Engl J Med en_US


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