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Anti-HIV Gel Found Safe and Well Tolerated Intravaginally
The results of in vitro studies indicate that dextrin sulphate (D2), a sulphated polysaccharide, is a potent inhibitor of several HIV-1 strains. London researchers now report that dextrin sulphate gel is also safe and well tolerated intravaginally.
Dr. Michael K. Stafford of Chelsea and Westminister Hospital and colleagues conducted a double-blind, placebo-controlled trial to evaluate the safety and tolerability of dextrin sulphate gel. Dr. Stafford's group recruited 36 healthy female volunteers who received 5 mL doses that contained 100 mcg/mL dextrin sulphate, 30 mcg/mL dextrin sulphate, or a placebo gel. The researchers obtained patient reports of tolerability and also performed colposcopy with vaginal biopsy for evidence of inflammation. In addition, they used cultures to evaluate the gel's effect on vaginal flora.
Overall, Dr. Stafford's team concluded that the dextrin sulphate gel was safe and well tolerated at both doses. The only significant symptom was mild vulval pruritus, which occurred once in 5 of the subjects. They found no evidence of adverse effects on the vaginal epithelium or disruptions in vaginal bacterial ecology.
They caution, however, that no conclusions can be drawn at this stage about the likely tolerability and safety of the gel in the context of sexual intercourse. Abstinence from coitus was a prerequisite for trial entry because it was considered an important confounding variable.
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