AEGiS-14IAC: A safety study of dextrin sulphate gel as a novel vaginal microbicide: data from HIV negative and positive women.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

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A safety study of dextrin sulphate gel as a novel vaginal microbicide: data from HIV negative and positive women.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrD1317)

Low-Beer N, Jespers V, McCormack S, Gabe R, Nunn A, Chapman A, Damme LV, Lacey CJ
Imperial College School of Medicine, London, United Kingdom

BACKGROUND: Dextrin sulphate gel (DS) is a candidate vaginal microbicide against HIV-1. Data are presented from a safety study of DS vaginal gel in 80 sexually active HIV -ve and 20 HIV +ve women in London, UK and Antwerp, Belgium.

METHODS: In part A, 50 HIV -ve women were double-blind randomised to receive 0% (n=10), 1% (n=20), or 4% DS gel (n=20). Following analysis of part A, part B enrolled 30 women (20 HIV +ve and 10 HIV -ve), who received open label 4% DS gel and 20 HIV -ve women, who were no-treatment controls. In both studies the study gel was applied twice daily for 14 days. Local toxicity was assessed by colposcopy and (UK only) by histology of vaginal biopsies. Systemic toxicity was determined by coagulation studies. Cervico-vaginal lavages (CVL) were assayed for cytokines and chemokines, and HIV-RNA.

RESULTS: There was no genital epithelial disruption (colposcopy), inflammation (biopsy), or evidence of systemic toxicity associated with gel use. Of the HIV -ve women, intermenstrual bleeding was observed in 7/30 of 4% DS, 5/20 of 1% DS, 4/10 of 0% DS, 1/20 of observation-only controls, and in 7/20 of the HIV +ve women receiving 4% DS.

CONCLUSIONS: There was no excess of local or systemic toxicity in HIV-ve or HIV+ve women using 4% DS gel compared with HIV-ve women using 1% DS gel or placebo. An unexpectedly high frequency of intermenstrual bleeding, as yet unexplained, occurred in all gel groups (including those using placebo gel) compared with observation-only controls.

Keywords: AEGIS, HIV, HIV Infections, Dextrins, Vagina, Gels, Anti-Infective Agents, Vaginal Creams, Foams and Jellies, Spermatocidal Agents, Safety, HIV Seropositivity, Colposcopy, Sulfates, HIV-1, Belgium, London, caloreen, Human, FemaleKWDaegis,hiv,hivinfections,dextrins,vagina,gels,anti-infectiveagents,vaginalcreams,foamsandjellies,spermatocidalagents,safety,hivseropositivity,colposcopy,sulfates,hiv-1,belgium,london,caloreen,human,female

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Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.