The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.
This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
6,203
Isipingo Clinic
Overport, Durban, South Africa
Empilisweni Clinic
Cape Town, South Africa
Setshaba Research Clinic, University of Limpopo - Medunsa Campus
Medunsa, South Africa
Time to HIV seroconversion during trial participation (evaluated quarterly)
Determine long-term safety based on the incidence of sexually transmitted infections (STI), Chlamydia, gonorrhoeae, trichomoniasis, and syphilis tests and the number of adverse events and serious adverse events
Chlamydia, gonorrhoeae, trichomoniasis and syphilis tests are conducted at months 3, 6, 12, 18 and 24 and as clinically indicated
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