AEGiS-13IAC: Dextrin sulphate: its continued development as a vaginal microbicide preventing HIV transmission.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Dextrin sulphate: its continued development as a vaginal microbicide preventing HIV transmission.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrC665)

Chapman A, Peers EM, Brown CB
A. Chapman, ML Laboratories PLC, 25 Grosvenor Road, St Albans, Herts, AL1 3HW, United Kingdom, Tel.: +44 1727 73 93 00, Fax: +44 1727 83 58 67, E-mail: alanchap@aol.com

BACKGROUND: Dextrin sulphate, a sulphated polysaccharide, inhibits HIV infection in vitro by binding to a cell surface molecule and blocking viral entry. Formulated as an intravaginal gel (Emmelle?), the compound is being developed as a vaginal microbicide to reduce heterosexual HIV transmission.

METHODS: To date, two randomised, double blind, placebo controlled, safety and tolerability trials of dextrin sulphate gel have been completed in non sexually-active, HIV negative, healthy female volunteers. A single dose of study gel (5 ml) was administered on retiring to bed each night on five consecutive occasions. Assessments included full blood count, clinical chemistry, coagulation tests, colposcopic examination, vaginal biopsies (study 1), STD screen and lactobacillus isolation.? Study 1: 37 women were randomised to receive either dextrin sulphate (150 micrograms/dose 'n = 12', 500micrograms/dose 'n = 13') or placebo (base gel, 'n = 12'). ? Study 2: 20 women were randomised to receive either dextrin sulphate (2500 micrograms/dose 'n = 12') or placebo (base gel 'n = 8').

RESULTS: No clinical effects were observed between treatment groups to suggest an effect of dextrin sulphate on haematological, biochemical or clotting parameters. Dextrin sulphate does not appear to influence vaginal pH or ecology, particularly the lactobacillus population. In addition, there was no evidence of ulceration or epithelial disruption of the vulva, cervix or vagina on colposcopic examination. No inflammation was observed in the vaginal biopsies from study 1.

CONCLUSIONS: Both trials indicate dextrin sulphate gel is well tolerated at doses up to 2500 micrograms. Clinical development of the gel is continuing, with a dose ranging study and a study conducted in Africa planned for this year, both in sexually active women ± HIV infection.

Keywords: AEGIS, Dextrins, HIV Infections, Vagina, Anti-Infective Agents, HIV Seropositivity, Sulfates, Spermatocidal Agents, Gels, Vulva, Coitus, Lactobacillus, Africa, caloreen, Human, Female, In Vitro, transmission
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ThOrC665