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Effectiveness of cellulose sulfate gel for prevention of HIV: results of the phase III trial in Nigeria
Presented by Willard Cates Jr, United States.
Halpern V.1, Wang L.1, Obunge O.2, Ogunsola F.3, Mehta N.1, Onyejepu N.2, Oduyebo O.3, Taylor D.1, Otusanya S.3, Umo-Otong J.2, McNeil L.1, Bragg V.1, Cates, Jr. W.1
1Family Health International, Research Triangle Park, United States, 2University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria, 3College of Medicine, University of Lagos, Lagos, Nigeria
Objectives: Determine the effectiveness of cellulose sulfate (CS) gel in preventing male-to-female vaginal transmission of HIV in women at high risk of HIV and other STIs.
Methods: We conducted a phase III, randomized, placebo-controlled trial in Lagos and Port Harcourt, Nigeria. We planned to enroll 2160 HIV-negative women at high risk of infection. Risk-reduction counseling and free condoms were provided to all women throughout the study. The study participants were instructed to use study gel and a condom during each act of sexual intercourse during one year. HIV testing was conducted at baseline and monthly during one-year follow-up for each participant. The main analysis was conducted on an intent-to-treat basis.
Results: We started enrollment on 22 December 2004. The study was prematurely stopped on 31 January 2007 due to the unexpected negative effect on HIV acquisition observed in an interim analysis of data from a parallel trial of CS. Before our study was stopped, we screened a total of 3618 women, of whom 1644 were enrolled and 1153 completed the final study visit. A total of 1511 women provided at least one HIV result during the follow up and were included in the primary analysis for HIV. The full analysis is on-going; the number of HIV events in the treatment and placebo arms, relative risk estimate and p-value will be presented at the conference.
Conclusions: We were not able to demonstrate a preventive effect of CS gel on vaginal transmission of HIV.
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