Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa.
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.
van de Wijgert
Janneke H H M
JH
Population Council, New York, NY, USA. j.h.vandewijgert@amc.uva.nl
Braunstein
Sarah L
SL
Morar
Neetha S
NS
Jones
Heidi E
HE
Madurai
Lorna
L
Strickfaden
Tammy T Evans
TT
Moodley
Manivasan
M
Aboobaker
Jamila
J
Ndlovu
Gugulethu
G
Ferguson
Taja M
TM
Friedland
Barbara A
BA
Hart
Clyde E
CE
Ramjee
Gita
G
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
D000891:Anti-Infective Agents, Local; D010919:Placebos; D012367:RNA, Viral; D014622:Vaginal Creams, Foams, and Jellies