title: Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa.
abstract: OBJECTIVE
  To assess the safety of the candidate microbicide Carraguard gel in HIV-positive women and men.
  
  
  METHODS
  A randomized, placebo-controlled, triple-blinded clinical trial of Carraguard gel when applied vaginally once per day for 14 intermenstrual days by sexually abstinent and sexually active HIV-positive women; and when applied directly to the penis once per day for 7 days by sexually abstinent HIV-positive men.
  
  
  METHODS
  In each cohort (n = 20 per cohort), participants were randomized to Carraguard, methylcellulose placebo, or no product (1:1:1). In addition to traditional microbicide trial safety endpoints, the effects of microbicide use on vaginal shedding of HIV-1 RNA and markers of genital inflammation, epithelial sloughing, and microhemorrhage were also explored.
  
  
  RESULTS
  Gel compliance was high in both gel-use groups in the 3 cohorts. Carraguard use was not associated with abnormal genital findings, other abnormal clinical findings, markers of genital inflammation, epithelial sloughing or microhemorrhage, or self-reported symptoms in women and men, or with abnormal vaginal flora or genital shedding of HIV-1 RNA in women. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups.
  
  
  CONCLUSIONS
  Once-daily use of Carraguard for 7 to 14 days appeared to be safe in HIV-positive women and men.
authors.affiliation: Population Council, New York, NY, USA. j.h.vandewijgert@amc.uva.nl
authors.forename: Janneke H H M
authors.initials: JH
authors.lastname: van de Wijgert
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Braunstein
authors.forename: Neetha S
authors.initials: NS
authors.lastname: Morar
authors.forename: Heidi E
authors.initials: HE
authors.lastname: Jones
authors.forename: Lorna
authors.initials: L
authors.lastname: Madurai
authors.forename: Tammy T Evans
authors.initials: TT
authors.lastname: Strickfaden
authors.forename: Manivasan
authors.initials: M
authors.lastname: Moodley
authors.forename: Jamila
authors.initials: J
authors.lastname: Aboobaker
authors.forename: Gugulethu
authors.initials: G
authors.lastname: Ndlovu
authors.forename: Taja M
authors.initials: TM
authors.lastname: Ferguson
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Friedland
authors.forename: Clyde E
authors.initials: CE
authors.lastname: Hart
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D052776:Female Urogenital Diseases / Q000473:pathology; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D052801:Male Urogenital Diseases / Q000473:pathology; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D012367:RNA, Viral / Q000235:genetics; D013019:South Africa; D014621:Vagina / Q000473:pathology / Q000821:virology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects*; D017201:Virus Shedding
chemical_list: D000891:Anti-Infective Agents, Local; D010919:Placebos; D012367:RNA, Viral; D014622:Vaginal Creams, Foams, and Jellies