HIVNET 020: TRIAL OF INVESTIGATIONAL VAGINAL MICROBICIDE PRO 2000/5 GEL

University Of Pennsylvania, Philadelphia PA

Investigators

Linked publications & trials

Abstract

The primary objective of this protocol is to assess the safety of intravaginal 2% and 4% PRO2000/5 Gel (P) administered once or twice daily for fourteen consecutive days on the vulvar and cervicovaginal mucosa of sexually active HIV-negative women at low risk for HIV infection and sexually abstinent, asymptomatic HIV-positive women, through a dose and frequency escalation study. Secondary objectives of this study are: (1) to assess the acceptability of, and adherence to, a short term regimen of PRO2000/5 Gel (P) use among sexually active HIV-negative women at low risk for HIV infection and sexually abstinent HIV positive women; and (2) to evaluate aspects of acceptability and adherence, such as applicator-associated factors, vehicle-associated factors, and use-associated factors.