Carraguard vaginal gel safety in HIV-positive women and men in South Africa
van de Wijgert,Janneke; Braunstein,Sarah; Morar,Neetha S.; Jones,Heidi E.; Madurai,Lorna; Evans Strickfaden,Tammy T.; Moodley,Manivasan; Aboobaker,Jamila; Ndlovu,Gugulethu; Ferguson,Taja M.; Friedland,Barbara A.; Hart,Clyde E.; Ramjee,Gita
Journal of Acquired Immune Deficiency Syndromes 46(5): 538-546
Publication date: 2007
To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men.
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.
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.
Gel compliance was high in both gel-use groups in the 3 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.
Once-daily use of Carraguard for 7 to 14 days appeared to be safe in HIV-positive women and men.