FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 359:463-472 July 31, 2008 Number 5 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

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 [ClinicalTrials.gov] ; and Current Controlled Trials number, ISRCTN95638385 [controlled-trials.com] .)

Source Information

From CONRAD, Arlington, VA (L.V.D.); Family Health International, Research Triangle Park, NC (L.V.D., J.D., D.T.); HIV Prevention Research Unit, Medical Research Council, Durban, South Africa (R.G., G.R.); Makarere University, Kampala, Uganda (F.M.M., B.P.); Centre Hospitalier Affilié Universitaire de Québec, Quebec, Canada (F.G., M.A.); Y.R. Gaitonde Center for AIDS Research and Education (Y.R.G. CARE), Chennai, India (S.S., A.K.K.); Department of Medical Microbiology, University of Manitoba, Winnipeg, Canada (M.L.B.); Institute of Population Health and Clinical Research, St. John's Medical College, Bangalore, India (B.S.P.); and the Institute of Tropical Medicine, Department of Microbiology, Antwerp, Belgium (T.C.).

Address reprint requests to Dr. Van Damme at FHI, 4401 Wilson Blvd., Suite 700, Arlington, VA 22203, or at lvandamme{at}fhi.org.

Full Text of this Article

Related Letters:

Cellulose Sulfate for Prevention of HIV Infection
Neurath A. R., Richards C., Tao W., Hamer D., Van Damme L., Taylor D.
Extract | Full Text | PDF  
N Engl J Med 2008; 359:2066-2068, Nov 6, 2008. Correspondence

HOME  |  SUBSCRIBE  |  SEARCH  |  CURRENT ISSUE  |  PAST ISSUES  |  COLLECTIONS  |  PRIVACY  |  HELP  |  beta.nejm.org Comments and questions? Please contact us. The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved.