Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel

Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
AIDS (Impact Factor: 5.55). 01/2006; 19(18):2157-63. DOI: 10.1097/01.aids.0000194797.59046.8f
Source: PubMed


An expanded Phase I trial was performed to assess the safety and acceptability of 6% cellulose sulfate gel (CS) in comparison with K-Y Jelly.
Sexually abstinent (cohort I) and sexually active (cohort II) women in India, Nigeria and Uganda applied 3.5 ml of either 6% CS gel or K-Y Jelly for seven consecutive days. Safety was assessed by symptoms and signs (including colposcopy) of genital irritation, review of adverse events, and by changes in vaginal health as assessed by microscopy.
One hundred and eighty women (90 on CS and 90 on K-Y Jelly) were enrolled. Baseline characteristics of women in both gel groups were similar. In cohort I, six (14%) women on CS and 12 (27%) on K-Y Jelly reported genital symptoms, two (in K-Y Jelly group) of whom withdrew from the study. New colposcopy findings or findings showing deterioration were detected in four (9%) women on CS and nine (21%) women on K-Y Jelly in cohort I. Two women on CS and three on K-Y Jelly in cohort II reported genital symptoms. Five women (11%) in each gel group in cohort II had new colposcopy findings or findings showing deterioration. The differences between the gel groups were not statistically significant. The majority of women had no problem with their assigned product.
A vaginal application of 6% cellulose sulfate twice daily for seven consecutive days is as safe and well tolerated as a similar regimen of K-Y Jelly. Further development of 6% CS for prevention of HIV and pregnancy is recommended.

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    • "Although microbicides are used by women, gender norms will still influence how and when women use microbicides. Evidence to date shows that women and men in the Americas tend toward prioritizing the need for microbicides that would be " unnoticeable " during sex[60,184185186187188189. Studies in Thailand and India have focused on whether or not it would be feasible to use a microbicide without a partner noticing it, with seven studies (two from India, four from Thailand, and one from both) tending toward use without partner's knowledge not being feasible[30,62,90,102,103,184,190,191]and five studies (two from India and three from Thailand) tending toward it being feasible[103,139,192193194. In a few studies, a motivation to discuss use with stable partners was driven by a desire to avoid accusations of infidelity if the partner noticed the gel during sex[30,139,191,193]. "

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    • "Because the cervicovaginal environment is open, microbicide products can leak out over time. For example, in clinical trials involving Ushercell, compound leakage was reported by female users, and product leakage had a negative effect on product acceptability [41, 42]. In a scenario in which product leakage has sufficiently reduced the concentration of the active compound (i.e., cellulose sulfate) within the cervicovaginal environment, HIV-1 transmission may be enhanced rather than inhibited. "
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