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A dose-ranging phase I study of dextrin sulphate, a vaginal microbicide, in HIV-negative and HIV-positive female volunteers

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dc.contributor.author McCormack, S. en_US
dc.contributor.author Jespers, V. en_US
dc.contributor.author Low-Beer, N. en_US
dc.contributor.author Gabe, R. en_US
dc.contributor.author Kaganson, N. en_US
dc.contributor.author Chapman, A. en_US
dc.contributor.author Nunn, A. en_US
dc.contributor.author Lacey, C. en_US
dc.contributor.author Van Damme, L. en_US
dc.date.accessioned 2007-12-06T14:47:34Z
dc.date.available 2007-12-06T14:47:34Z
dc.date.issued 2005 en_US
dc.identifier.issn 0148-5717 en_US
dc.identifier.doi http://dx.doi.org/10.1097/01.olq.0000175380.27057.2c
dc.identifier.other ITG-M2A en_US
dc.identifier.other MICRO en_US
dc.identifier.other U-HIVSTD en_US
dc.identifier.other JIF en_US
dc.identifier.other DOI en_US
dc.identifier.other ABSTRACT en_US
dc.identifier.uri http://hdl.handle.net/10390/1860
dc.description.abstract DESIGN: This phase I dose-ranging study of 2 weeks of twice-daily dextrin sulphate (DS), a sulphated polymer with in vitro activity against HIV, was designed in 2 parts. Part A was a randomized, placebo-controlled, double-blind, 3-arm trial (DS4%, DS1%, placebo) in HIV-negative women. In part B, HIV-positive women received DS4% and HIV-negative women were randomized to DS4% or no gel. RESULTS: One hundred women were enrolled from 2 sites (London and Antwerp): DS4% (n = 50, 20 of whom were HIV-positive), DS1% (n = 20), placebo (n = 10) and no gel (n = 20). There were no withdrawals related to adverse events and no cases of epithelial disruption. Spotting was reported by 24 women and numbers were significantly higher in all the gel groups (23 of 80), including placebo, compared with no gel (one of 20) (Fisher exact test P = 0.037). There was no evidence of a dose effect. Safety tests showed no evidence of systemic absorption. CONCLUSION: Although there was no clear explanation for the spotting, DS4% was well tolerated. It was decided to proceed with DS4% in an expanded safety study in Africa but to restrict entry to low-risk HIV-negative women, include a no-gel group, and monitor intermenstrual bleeding closely. en_US
dc.language English en_US
dc.subject Viral diseases en_US
dc.subject HIV en_US
dc.subject Microbicides en_US
dc.subject Dextrin sulphate en_US
dc.subject Tolerability en_US
dc.subject Safety en_US
dc.title A dose-ranging phase I study of dextrin sulphate, a vaginal microbicide, in HIV-negative and HIV-positive female volunteers en_US
dc.type Article en_US
dc.citation.issue 12 en_US
dc.citation.jtitle Sexually Transmitted Diseases en_US
dc.citation.volume 32 en_US
dc.citation.pages 765-770 en_US
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/16314774
dc.citation.jabbreviation Sex Transm Dis en_US


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