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A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand.
Sex Transm Dis. 2008 Mar; 35(3):226-32.ST

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.

Authors+Show Affiliations

National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. pbk4@cdc.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

18490865

Citation

Kilmarx, Peter H., et al. "A Randomized, Placebo-controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel By Heterosexual Couples in Thailand." Sexually Transmitted Diseases, vol. 35, no. 3, 2008, pp. 226-32.
Kilmarx PH, Blanchard K, Chaikummao S, et al. A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand. Sex Transm Dis. 2008;35(3):226-32.
Kilmarx, P. H., Blanchard, K., Chaikummao, S., Friedland, B. A., Srivirojana, N., Connolly, C., Witwatwongwana, P., Supawitkul, S., Mock, P. A., Chaowanachan, T., & Tappero, J. (2008). A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand. Sexually Transmitted Diseases, 35(3), 226-32. https://doi.org/10.1097/OLQ.0b013e31815d6e0d
Kilmarx PH, et al. A Randomized, Placebo-controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel By Heterosexual Couples in Thailand. Sex Transm Dis. 2008;35(3):226-32. PubMed PMID: 18490865.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand. AU - Kilmarx,Peter H, AU - Blanchard,Kelly, AU - Chaikummao,Supaporn, AU - Friedland,Barbara A, AU - Srivirojana,Nucharee, AU - Connolly,Cathy, AU - Witwatwongwana,Paisit, AU - Supawitkul,Somsak, AU - Mock,Philip A, AU - Chaowanachan,Thanyanan, AU - Tappero,Jordan, PY - 2008/5/21/pubmed PY - 2008/7/19/medline PY - 2008/5/21/entrez SP - 226 EP - 32 JF - Sexually transmitted diseases JO - Sex Transm Dis VL - 35 IS - 3 N2 - 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. SN - 0148-5717 UR - https://www.unboundmedicine.com/medline/citation/18490865/A_randomized_placebo_controlled_trial_to_assess_the_safety_and_acceptability_of_use_of_carraguard_vaginal_gel_by_heterosexual_couples_in_Thailand_ L2 - https://doi.org/10.1097/OLQ.0b013e31815d6e0d DB - PRIME DP - Unbound Medicine ER -