Abstract
BackgroundThis trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection.MethodsThis 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.ResultsThe 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.ConclusionsCellulose 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 RegistrationClinicalTrials.gov NCT00120770
Highlights
As HIV has no cure, prevention technologies are needed to control the epidemic
Prompted by the promising laboratory data and a good safety profile demonstrated in earlyphase clinical trials [6,7,8,9], we proceeded to a Phase III study to evaluate the effectiveness of Cellulose sulfate (CS) gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection among sexually active women perceived to be at high risk of HIV acquisition
The effect of CS gel in preventing transmission of gonorrhea and chlamydial infection was primarily evaluated by a proportional hazards model that controlled for site and other pre-specified baseline prognostic variables including age, history of pregnancy and anal intercourse, previous use of spermicides, number of male partners and sexual acts not protected by condoms, and positive results for gonorrhea or chlamydial infection at enrollment
Summary
As HIV has no cure, prevention technologies are needed to control the epidemic. The most effective current methods of HIV prophylaxis, including abstinence, male condoms and male circumcision, are partially or wholly controlled by men. Prompted by the promising laboratory data and a good safety profile demonstrated in earlyphase clinical trials [6,7,8,9], we proceeded to a Phase III study to evaluate the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection among sexually active women perceived to be at high risk of HIV acquisition. 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
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