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

Jespers, V.; Buvé, A.; Van Damme, L.

Sexually Transmitted Diseases 34(7): 519-522

2007

ISSN/ISBN: 0148-5717
PMID: 17297382
DOI: 10.1097/01.olq.0000253340.76118.89
Document Number: 207253
Objective: Cellulose sulfate (CS) is a promising vaginal microbicide. Because men will he 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.

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