Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women.
OBJECTIVE
Few studies of topical microbicides have assessed their safety in HIV-infected women. We conducted this study to evaluate the safety and acceptability of 6% cellulose sulfate (CS) gel as a vaginal microbicide in sexually abstinent and active HIV-infected women.


METHODS
Fifty-nine HIV-infected women were enrolled in a randomized double-blind placebo-controlled study comparing 6% CS to placebo gel used for 14 days. Sexually abstinent women applied gel once or twice daily and sexually active women used gel once daily.


RESULTS
CS gel was safe with no reported severe or life-threatening adverse events (AE). Thirty-nine (66%) of the participants experienced urogenital AE judged as probably or possibly related to gel. The majority (51%) of these participants reported only mild events. Fewer women (62%) who used CS experienced urogenital AE than those assigned to placebo gel (70%) (P = 0.59). Eleven (19%) women experienced intermenstrual bleeding judged to be probably or possibly related to gel use (four in the CS and seven in the placebo gel group). There was no increase in AE by frequency of gel use or sexual activity with the exception of abdominal/pelvic pain which was noted more frequently with twice daily use among sexually abstinent women. Women and men found the gel highly acceptable.


CONCLUSIONS
This Phase I study demonstrated that CS vaginal gel was safe, well tolerated and acceptable by HIV-infected women and their male partners. Thus, further development of CS is warranted as a potential method to prevent HIV transmission and acquisition.
El-Sadr
Wafaa M
WM
Harlem Hospital Center, 506 Lenox Avenue, New York, NY 10037, USA. wme1@columbia.edu
Mayer
Kenneth H
KH
Maslankowski
Lisa
L
Hoesley
Craig
C
Justman
Jessica
J
Gai
Fang
F
Mauck
Christine
C
Absalon
Judith
J
Morrow
Kathleen
K
Mâsse
Benoît
B
Soto-Torres
Lydia
L
Kwiecien
Antonia
A
D015746:Abdominal Pain / Q000139:chemically induced; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D012746:Sexual Abstinence; D014622:Vaginal Creams, Foams, and Jellies
D019380:Anti-HIV Agents; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; C020254:cellulose sulfate