HIV Prevention Research Unit
Population
Council Funded – Phase I Safety and Acceptability Study of Carraguard
(PC515) among HIV Positive Women & Men
Principle Investigator: Gita Ramjee
Co-Investigator: Neetha Morar
Site: MRC Clinic, Durban
Introduction
The Phase I Carraguard safety study which started in May 2002 completed data
collection in mid August 2003 for both abstinent and active cohorts. The first
phase of the data query process in South Africa was also completed in December
2003.
Microbicides are likely
to be used by HIV-positive women once they are on the market. Many women who
choose to use a microbicide may not know their HIV-status; others may be aware
that they have HIV and may wish to use a microbicide to avoid other sexually
transmitted infections (STIs) or to protect their partners from infection.
It is therefore important to know whether HIV-positive women and couples can
safely use a potential microbicide.
Objectives
 |
To investigate changes
in the vulva, vaginal and cervical epithelia, |
|
To investigate changes
in the vaginal flora, |
|
To assess HIV-1 shedding
in the genital tract of female participants, |
|
To assess changes
of the penile skin and epithelia of male participants. |
|
To assess acceptability
of and compliance with the study or placebo gel. |
|
