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Inconclusive Results of Cellulose Sulfate Microbicide TrialA USAID-supported Nigerian trial evaluating the potential of 6-percent cellulose sulfate (CS) gel as a vaginal microbicide was stopped before conclusive evidence could be obtained about the product's efficacy. Scientists from Family Health International, the University of Lagos, and the University of Port Harcourt, in Nigeria, sought to determine whether the CS gel could prevent male-to-female vaginal transmission of HIV, gonorrhea, and chlamydia. More than 1,600 Nigerian women at high risk of HIV infection were enrolled in the trial, which was expected to last for one year. The women were randomly assigned to use either the CS gel or a placebo gel during each act of sexual intercourse in that period. The trial ended early because of safety concerns raised by the interim results of a parallel trial, also supported in part by USAID. Conducted by the Cellulose Sulfate Study Group (whose members include CONRAD and Family Health International), the parallel trial enrolled 1,425 women at high risk of HIV infection in three sites in Africa and two sites in India. The results of that trial were not statistically significant, but they showed that more women who used the CS gel contracted HIV than did women who used the placebo gel. Although the trial in Nigeria showed no evidence of increased risk (there were slightly fewer infections in the CS group than in the placebo group), the weight of evidence from the combined trials warranted their closure -- a disappointment in the global effort to develop a viable microbicide. Source |
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