AEGiS-14IAC: A randomized, placebo-controlled, double-blind expanded safety trial of CarraguardÃ‚Â® microbicide gel in South Africa: Signs and symptoms of genital irritation.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

A randomized, placebo-controlled, double-blind expanded safety trial of Carraguard é « microbicide gel in South Africa: Signs and symptoms of genital irritation.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1316)

Coetzee N, Hoosen A, Blanchard K, de Kock A, Sebola M, Friedland B, Ellertson C, Nkompela B, Altini L, Ndlovu G, Tweedy K
University of Cape Town, Cape Town, South Africa

BACKGROUND: Carraguard é «, a 3% carrageenan gel, is a promising candidate microbicide based on results from in vitro and in vivo preclinical studies, and Phase I clinical safety studies.

METHODS: 400 healthy HIV negative women from the general population were enrolled, 200 each in two sites, Gugulethu and Ga-Rankuwa, South Africa. Women who were pregnant or planning to become pregnant or had persistent genital abnormalities or RTI were excluded. All women gave informed consent, and were randomized to receive either Carraguard é « or placebo (methyl cellulose) gel. Women were asked to insert gel (about 4 ml) at least 3 times per week and prior to each act of sexual intercourse for up to 12 months. All women returned to the clinic monthly for interview, pelvic examination, and safer sex counseling.

RESULTS: Preliminary data from an interim analysis at about 100 woman-years of follow-up showed both gels to be safe. Figures here represent the percentage of women who ever reported an outcome during follow-up. In both groups, more than 90% reported no symptoms attributable to gel use, and 80% reported no genital itching, burning or pain. Findings from pelvic exams showed 88% and 89% had no visible abnormalities on the vulva or labia, 94% in both groups had no visible vaginal abnormalities and 89% had no visible cervical abnormalities. Data collection was completed November 30, 2001 and full analysis is underway. We will present unblinded results from the full follow-up period at the conference.

CONCLUSIONS: Signs and symptoms of genital irritation were rare in women using Carraguard é « or methyl cellulose placebo gel. Both gels appear safe for larger scale testing, and Phase III effectiveness evaluation of Carraguard é « is planned.

Keywords: AEGIS, Double-Blind Method, Placebos, Gels, Anti-Infective Agents, Randomized Controlled Trials, Safety, Vagina, Treatment Outcome, South Africa, Human, Female, In Vitro, Pregnancy, diagnosis

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