Article

Effectiveness of Cellulose Sulfate Vaginal Gel for the Prevention of HIV Infection: Results of a Phase III Trial in Nigeria

Tulane University, United States of America
PLoS ONE (Impact Factor: 3.53). 02/2008; 3(11):e3784. DOI: 10.1371/journal.pone.0003784
Source: PubMed

ABSTRACT This 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.
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.
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.
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.
ClinicalTrials.gov NCT00120770.

Download full-text

Full-text

Available from: Saïd Abdellati, Jul 14, 2014
0 Followers
 · 
128 Views
  • Source
    • "This has motivated concerted research efforts towards developing female-controlled prevention methods and drove the intense promotion of the female condom in the late 1990s (Mantell et al. 2000; Warren & Philpott 2003). Numerous randomised controlled trials of microbicide candidates (Table 1) were subsequently carried out to no avail (Kreiss et al. 1992; Roddy et al. 1998; Van Damme et al. 2002, 2008; Peterson et al. 2007a; Feldblum et al. 2008; Halpern et al. 2008; Skoler-Karpoff et al. 2008; Abdool Karim et al. 2009b; McComack et al. 2010). The preparations may have facilitated HIV infection in some instances (Kreiss et al. 1992; Van Damme et al. 2002, 2008). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Southern Africa continues to shoulder a disproportionate burden of the HIV epidemic with the number of new infections outstripping treatment initiation two- to threefold. Current prevention strategies have had a limited impact on the trajectory of the epidemic so far. The history of HIV prevention research is dominated by failed approaches, but recent developments have provided reason for hope. These include the successful male circumcision outcomes in trials in South Africa, Kenya and Uganda, the recent protective outcome of a tenofovir vaginal gel trial in South Africa and the proof that pre-exposure prophylaxis with oral combination tenofovir/emtricitabine can work in men. The latter positive outcome has however been shattered by the early closure of FEM-PrEP for futility. The challenge now is on how to best integrate emerging prevention methods with established strategies, recognising that some of the older methods have never been scaled up to saturation level.
    Tropical Medicine & International Health 06/2011; 16(9):1120-30. DOI:10.1111/j.1365-3156.2011.02807.x · 2.30 Impact Factor
  • Source
    • "Approximately 50 candidates are currently at different stages of development in the microbicide pipeline (for a full list see www.microbicide.org). So far mostly non-specific microbicides, such as surfactants and polyanions, have completed phase III clinical testing and none has demonstrated clear statistical evidence of protection (Feldblum et al., 2008; Halpern et al., 2008; Karim, 2010; Peterson et al., 2007; Van Damme et al., 2002, 2008). There is hope, however, that better results will be achieved with agents that specifically inhibit HIV, some of which have shown quite remarkable efficacy in explant tissue and animal infection models (Cranage et al., 2008; Cummins et al., 2007; Denton et al., 2008; Lederman "
    [Show abstract] [Hide abstract]
    ABSTRACT: A combination of prevention and treatment modalities will be needed to successfully control the global spread of HIV. Microbicides, drug products topically applied to mucosal surfaces to prevent HIV infection, are one of these biomedical interventions that hold great promise. In order to be efficacious, microbicides must overcome several challenges imposed by the mucosal microenvironment they intend to protect and the mischievous human immunodeficiency virus with its enormous capacity to adapt. Recent data, however, supports the establishment of the primo-infection by only a small number of founder viruses, which are highly vulnerable to microbicidal intervention at the initial stages of mucosal invasion. The biological foundation of these challenges and opportunities in microbicide development is explored in this review. This article forms part of a special supplement on presentations covering HIV transmission and microbicides, based on the symposium "Trends in Microbicide Formulations", held on 25 and 26 January 2010, Arlington, VA.
    Antiviral research 12/2010; 88 Suppl 1(supplement 1):S3-9. DOI:10.1016/j.antiviral.2010.09.011 · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: This paper presents an ABR control scheme (ABR 2 - DP) which maximises the utilisation of information available about the network traffic. Firsfly, it takes into account the long-range dependence of the self-similar background network traffic, and utilises it for more accurate multi-step predictions of the explicit rate (ER). Secondly, prediction errors for connections with greater network delay are compensated for in the ER calculations for connections with smaller delay. Hence, the available bandwidth is distributed both in temporal and spatial dimensions. The scheme allows a reduction in buffer requirements and queueing delay. Performance results are presented and compared with a previously proposed scheme which uses digital filtering.
Show more