AEGiS-15IAC: Safety and acceptability of Carraguard use among heterosexual couples in a six-month clinical trial in Thailand.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Safety and acceptability of Carraguard use among heterosexual couples in a six-month clinical trial in Thailand.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrB1374)

Kilmarx PH, Blanchard K, Witwatwongwana P, Supawitkul S, Chaikummao S, Connolly C, Friedland B, Mock PA, Tappero J
Thailand MOPH-US CDC Collaboration, Bangkok, Thailand

BACKGROUND: In phase II trials Carraguard use has been shown to be safe and acceptable in women. To evaluate safety and acceptability among heterosexual couples, we conducted a six-month, randomized, triple-blinded trial of Carraguard (3% carrageenan) compared to 2.5% methyl cellulose placebo in Chiang Rai, Thailand.

METHODS: We enrolled 55 low-risk couples who were in good health, were monogamous, did not use condoms regularly, and were free of HIV or other sexually transmitted infections (STIs). Couples were randomized to Carraguard or placebo gel and were asked to use the gel each time they had vaginal sex. Couples came for monthly follow-up visits including genital/pelvic exams, STI testing, interview and counseling.

RESULTS: Follow up and adherence with gel use instructions were >90% at each scheduled visit. During follow up four men in group I (15%) and five men in group II (18%) reported any genital itching, burning or pain; one man in each group reported that they believed that the gel itself caused itching, burning or pain, and one man in each group reported the gel caused other (mild) symptoms. We found no cases of deep epithelial disruption among men; (small) superficial epithelial disruption occurred among 15% and 21% of men in each group. There were no cases of balanitis or urethral discharge. Acceptability remained consistently and similarly high in both groups. At study close, 85% of men and 92% of women reported they liked the gel somewhat or very much; 73% of men and 67% of women reported increased sexual pleasure.

CONCLUSIONS: These data indicate that Carraguard did not cause significant irritation or harm to the male genitalia when used by low-risk heterosexual couples during vaginal intercourse, and Carraguard use was acceptable to low-risk heterosexual couples in northern Thailand.

Keywords: AEGIS, Heterosexuality, Thailand, Clinical Trials, Condoms, Safety, Placebos, HIV Seropositivity, Double-Blind Method, Time, Humans, Male, Female, utilization

040711
ThOrB1374