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Carraguard Trial
Progresses to Data Analysis
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Digital scanners were used to
collect and record information during the Phase 3
trial of Carraguard.
Photo credit: Bev Symmonds |
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On March 31, the Population Council completed data
collection in the large-scale clinical trial of the Council-developed
microbicide gel, Carraguard®. The trial was conducted in
collaboration with researchers at three sites in South Africa, where
high prevalence of HIV in the study communities makes it possible to
assess in a relatively short time whether Carraguard prevents infection.
Data analysis is under way. Results—indicating the magnitude of effect
of Carraguard in preventing HIV transmission when the gel is used during
vaginal intercourse—are expected by the end of the year.
Carraguard is the first female-controlled product
developed specifically as a microbicide to complete a large-scale
clinical efficacy study. More than 6,000 women were enrolled and
randomly assigned to use Carraguard and a condom or a placebo gel and a
condom before each act of vaginal intercourse. Participants visited the
clinic quarterly for as long as two years, during which time they
received safer-sex counseling, pelvic exams, HIV tests, and testing and
treatment for sexually transmitted infections, in addition to condoms
and the study gel.
If Carraguard is shown to be effective and is
approved by the Medicines Control Council, the regulatory agency in
South Africa, the Population Council will work closely with
manufacturing partners and international organizations to facilitate
affordable access to Carraguard in South Africa and explore introduction
of the product in the developing world. Council biomedical scientists
have continued to develop second-generation microbicide candidates.
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