title: A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand.
abstract: OBJECTIVE
  To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men.
  
  
  METHODS
  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.affiliation: National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. pbk4@cdc.gov
authors.forename: Peter H
authors.initials: PH
authors.lastname: Kilmarx
authors.forename: Kelly
authors.initials: K
authors.lastname: Blanchard
authors.forename: Supaporn
authors.initials: S
authors.lastname: Chaikummao
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Friedland
authors.forename: Nucharee
authors.initials: N
authors.lastname: Srivirojana
authors.forename: Cathy
authors.initials: C
authors.lastname: Connolly
authors.forename: Paisit
authors.initials: P
authors.lastname: Witwatwongwana
authors.forename: Somsak
authors.initials: S
authors.lastname: Supawitkul
authors.forename: Philip A
authors.initials: PA
authors.lastname: Mock
authors.forename: Thanyanan
authors.initials: T
authors.lastname: Chaowanachan
authors.forename: Jordan
authors.initials: J
authors.lastname: Tappero
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002351:Carrageenan; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D020010:Heterosexuality; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care; D008517:Phytotherapy; D012747:Sexual Partners; D012749:Sexually Transmitted Diseases / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D013785:Thailand / Q000453:epidemiology; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies
chemical_list: D000890:Anti-Infective Agents; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan