Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women: Supporting Online Material

In April 2008, a CAPRISA 004 participant was found to be co-enrolled in another microbicide trial. A detailed investigation of all enrolled women at both study sites identified 135 women who had co-enrolled in CAPRISA 004 while still in follow-up in another microbicide trial and another 50 women who had participated in another microbicide trial within 12 months prior to CAPRISA 004. These 185 women, all from the urban clinic, were withdrawn from the study. Their exclusion from the primary analysis was based on criteria objectively assessed in all participants based on information collected prior to randomization and irrespective of treatment assignment, which is consistent with International Conference on Harmonization guidelines. Of the remaining 11 women not included in the primary analysis, one was under-age at enrolment, eight were in the window period of HIV infection at enrollment, and two had no post-randomization follow-up. The remaining 889 women were included in the analysis.