Safety and Acceptability of Carraguard® in HIV Positive Women and Men
Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
Participant gender:
Summary
The study objectives were to assess the mucosal safety of Carraguard® gel when applied
vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive
women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to
evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these
women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per
day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported
by female and male participants during the study may be related to the use of Carraguard®
gel; and to examine dimensions of the acceptability of, and compliance with, the study and
placebo products.
Phase:
Phase 1
Details
Lead Sponsor:
Population Council
Collaborators:
Centers for Disease Control and Prevention Medical Research Council