Sexually Transmitted Diseases

Skip Navigation LinksHome > March 2008 - Volume 35 - Issue 3 > A Randomized, Placebo-Controlled Trial to Assess the Safety...
Sexually Transmitted Diseases:
doi: 10.1097/OLQ.0b013e31815d6e0d
Article

A Randomized, Placebo-Controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel by Heterosexual Couples in Thailand

KILMARX, PETER H. MD*†; BLANCHARD, KELLY MSc‡; CHAIKUMMAO, SUPAPORN BHP†; FRIEDLAND, BARBARA A. BA‡; SRIVIROJANA, NUCHAREE MSc§; CONNOLLY, CATHY MPH∥; WITWATWONGWANA, PAISIT MD¶; SUPAWITKUL, SOMSAK MD**; MOCK, PHILIP A. MAppStats†; CHAOWANACHAN, THANYANAN MSc†; TAPPERO, JORDAN MD*†

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Abstract

Objectives: To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men.

Study Design: We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand.

Methods: Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview.

Results: Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable.

Conclusions: Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men.

© Copyright 2008 American Sexually Transmitted Diseases Association

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