Safety Trial of the Vaginal Microbicide Cellulose Sulfate Gel in HIV-Positive Men
2007; Lippincott Williams & Wilkins; Volume: 34; Issue: 7 Linguagem: Inglês
10.1097/01.olq.0000253340.76118.89
ISSN1537-4521
AutoresVicky Jespers, Anne Buvé, Lut Van Damme,
Tópico(s)Genital Health and Disease
ResumoIn Brief 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. Cellulose sulfate, a promising vaginal microbicide, was well tolerated by circumcised and uncircumcised HIV positive men in Belgium.
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