ABSTRACT

van de Wijgert, Janneke H.H.M., Sarah Braunstein, Neetha S. Morar, Heidi Jones, Lorna Madurai, Tammy T. Evans Strickfaden, Manivasan Moodley, Jamila Aboobaker, Gugulethu Ndlovu, Taja M. Ferguson, Barbara A. Friedland, Clyde E. Hart, and Gita Ramjee. 2007. "Carraguard vaginal gel safety in HIV-positive women and men in South Africa," Journal of Acquired Immune Deficiency Syndromes 46(5): 538–546.

Objective
To assess the safety of the candidate microbicide Carraguard® gel in HIV-positive women and men.

Design
A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men.

Methods
In each cohort (n=20 per cohort), participants were randomized to Carraguard, methylcellulose placebo, or no product (1:1:1). In addition to traditional microbicide trial safety endpoints, the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation, epithelial sloughing, and microhemorrhage were also explored.

Results
Gel compliance was high in both gel-use groups in the three cohorts. Carraguard use was not associated with abnormal genital findings, other abnormal clinical findings, markers of genital inflammation, epithelial sloughing or microhemorrhage, or self-reported symptoms in women and men, or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups.

Conclusions
Once-daily use of Carraguard for 7–14 days appeared to be safe in HIV-positive women and men.

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