HPTN 048

Phase I safety study of a vaginal microbicide: Polystyren

Study Summary

Information for this study is not available.

Study Details

Protocol Status:
Study Purpose:

To assess the safety, tolerance and acceptability of repeated intravaginal doses of Polystyrene Sulfonate gel in HIV-infected women.

Study Design:

Phase I trial (need for control arm to be determined) in HIV infected women, administering product twice daily for two weeks.

Study Population:

Women between the ages of 18 and 45 who are are HIV-1 infected, with a normal Pap smear and no clinically detectable genital abnormality

Study Size:

N=20. This allows for >90% power to detect toxicity rates of >20% where toxicity is defined as 2 or more women in the study having grade 3 adverse experiences judged by the investigator to be possibly, probably, or definitely related to study drug.

Study Duration:

Enrollment will be open for 4 months and all women followed for 21 days (14 days of product use, plus a 7 day safety follow-up check and focus group discussions).

Treatment Regimen:

Women will be asked to administer the product twice daily for two weeks.

Primary Objectives:

To assess local toxic effects of Polystyrene Sulfonate gel for vaginal use on vulvar and cervicovaginal mucosa in HIV infected women.

Secondary Objectives:

To access the acceptability of and adherence to, a short-term regimen of Polystyrene Sulfonate gel for vaginal use in HIV infected women.
To evaluate aspects of product acceptability and adherence.
To determine effects of PSS gel on genital viral load
To allow new HPTN sites to gain experience in microbicide safety evaluations and with the specific study product.

Study Sites List