Effectiveness of cellulose sulfate vaginal gel for the prevention of hiv infection: results of a phase III trial in Nigeria
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Date
2008-11
Authors
Halpern, V.
Ogunsola, F.T.
Obunge, O.
Wang, C.
Onyejepu, N.
Oduyebo, O.
Taylor, D.
Mcneil, L.
Mehta, N.
Umo-tong, J.
Journal Title
Journal ISSN
Volume Title
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Abstract
Background: This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-tofemale vaginal transmission of HIV, gonorrhea and chlamydial infection.
Methods: This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and
March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV
acquisition. Study participants were randomized 1:1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events.
Results: The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10) than on placebo (13), a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3–1.8; p = 0.56). Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5–1.1; p = 0.19 for the combined STI outcome). Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported.
Conclusions: Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV. Trial Registration: ClinicalTrials.gov NCT00120770
Description
Staff publications
Keywords
cellulose sulfate vaginal gel , Vaginal transmission , Chlamydial infection , Nigeria , Research Subject Categories::MEDICINE::Microbiology, immunology, infectious diseases
Citation
Halpern, V., Ogunsola, F., Obunge, O., Wang C., Onyejepu, N., Oduyebo, O., Taylor, D., Mcneil, L., Mehta, N., Umo-otong, J., Otusanya, S., Crucitti, T. and Abdellati, S. (2008). Effectiveness of Cellulose Sulfate Vaginal Gel for the Prevention of HIV Infection: Results of a Phase III Trial in Nigeria. PLoS ONE; 11 (3): 1 – 7 e3784. doi:10.1371/journal.pone.0003784.
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https://ir.unilag.edu.ng/handle/123456789/7257
https://ir.unilag.edu.ng/handle/123456789/7257