Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men.
OBJECTIVE
Cellulose sulfate (CS) is a promising vaginal microbicide. Because men will be exposed to the microbicide when engaging in vaginal intercourse, safety and acceptability need to be assessed in men.


METHODS
This randomized double-blind phase I study assessed the safety and acceptability of seven consecutive daily doses of CS versus KY Jelly in 36 HIV-positive men.


RESULTS
No new or worsening of existing genital findings were observed during the follow-up examination. Mild genital symptoms were reported in 42% of CS users (itching, burning, tingling, testicular pain, dysuria, and warm or cold feeling) and 8% of KY Jelly users.


CONCLUSIONS
CS gel applied to the penis was well tolerated in this HIV-positive male population. The itching and burning symptoms were not severe and can be explained by the preservative benzyl alcohol present in the CS gel.
Jespers
Vicky
V
Institute of Tropical Medicine, Antwerp, Belgium. vjespers@itg.be
Buvé
Anne
A
Van Damme
Lut
L
D000279:Administration, Cutaneous; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004311:Double-Blind Method; D005782:Gels; D015658:HIV Infections; D006801:Humans; D008297:Male; D008875:Middle Aged; D010413:Penis; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D005782:Gels; D002482:Cellulose; C020254:cellulose sulfate