Safety trial of the vaginal microbicide cellulose sulfate gel in HIV-positive men

Abstract

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. DESIGN: 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. CONCLUSION: 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.