AEGiS-14IAC: A year-long, randomized, controlled clinical trial of a carrageenan gel as a vaginal microbicide: Effect on reproductive tract infection (RTI) rates.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

A year-long, randomized, controlled clinical trial of a carrageenan gel as a vaginal microbicide: Effect on reproductive tract infection (RTI) rates.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1318)

Kilmarx PH, Supawitkul S, Yanpaisarn S, Jones H, van de Wijgert J, Young NL, Srivirojana N, Guest P
Thailand MOPH - U.S. CDC Collaboration, and Centers for Disease Control and Prevention, Nonthaburi, Thailand

BACKGROUND: Assessing the effect of vaginal microbicides on RTIs other than HIV is a critical aspect of the clinical evaluation of these products.

METHODS: Use of a 3% carrageenan gel (Carraguard[TM]) was compared with use of a 2.5% methyl-cellulose placebo gel in a year-long, randomized, triple-blinded study among 165 HIV-negative women recruited from family planning clinics in northern Thailand. Participants were instructed to use gel and condoms with each act of vaginal intercourse and to use gel at least three times per week whether on not they were sexually active. RTI testing was performed at monthly visits. All women had normal (class I) Pap smears at enrollment. Follow-up was completed in December 2001. Study arm assignment has not yet been unblinded.

RESULTS: Study retention at 12 months was 84% in Group A and 95% in Group B (P = .04). During 5,630 reported acts of sexual intercourse in Group A and 6,613 acts in Group B, use of gel was 89% and 91% and use of condoms was 73% and 62% (P < .001), respectively. Neither gel nor condoms were used during 6% of acts in both groups. There were no new cases of HIV infection and low rates of other sexually transmitted diseases with no significant differences between study arms. In Group A vs. B, the incidence of bacterial vaginosis (BV, Nugent criteria) was 31.5 vs. 40.5 per 100 woman-years (P = .4), and of presence of vaginal yeast was 52.0 vs. 43.0 per 100 woman-years (P = .4), respectively. Abnormal Pap smear (class II or higher) prevalence at 12 months was 26% vs. 17% (P = .3).

CONCLUSIONS: Study retention and adherence were high in this expanded safety study. One study arm had higher study retention and lower rates of condom use. There were no significant differences in rates of BV, presence of vaginal yeast, or Pap smear abnormality. A large phase III study is planned in light of these data and other data showing no significant differences in rates of genital lesions and very good acceptability.

Keywords: AEGIS, Anti-Infective Agents, Sexually Transmitted Diseases, Vagina, Gels, Condoms, Carrageenan, Respiratory Tract Infections, Spermatocidal Agents, HIV Infections, Placebos, Double-Blind Method, Incidence, Condoms, Female, Thailand, Human, Female, prevention & control

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WeOrD1318