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These video segments feature Population
Council researchers discussing microbicides and their work in developing the
Council's lead candidate microbicide, Carraguard®. Since the
segments were produced in 2003, some of the information may now be dated.
Please see the microbicides section of this Web site for additional, current
information about microbicides research and specifically about the Phase 3
clinical trial of Carraguard. (more)
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What are
microbicides and why are they needed?
The term “microbicides” refers to a range of products, in cream, gel,
film, or suppository form, that would substantially reduce the
transmission of HIV—and possibly other sexually transmitted
infections—when applied prior to sex. Globally, women’s rates of HIV
infection are growing far more rapidly than men’s, and the existing
strategies for prevention—mutual monogamy among HIV-negative partners,
condom use, and treatment of existing STIs—are not practical for many
women. That is why a female-initiated product is so essential. (more) |
Basic science
research on the sexual transmission of HIV leads to the development of
Carraguard
Population Council scientists have been exploring how HIV is transmitted
sexually since the late 1980s. After determining how HIV-infected cells in
semen and cervical-vaginal secretions could infect the reproductive tract’s
epithelial cells, they tested hundreds of compounds to determine which
effectively prevented infection. David Phillips describes his laboratory’s
work. (more) |
Carraguard
laboratory product development
In the product development stage of research, the Population Council
optimized its carrageenan formulation to create its lead candidate
microbicide, Carraguard. Director of microbicide product development Robin
Maguire and senior scientist David Phillips discuss how Carraguard was
discovered.
In the segment, Maguire describes toxicity tests that assessed local
irritation of the formulation when applied vaginally. Carraguard has a
two-year stability profile and is currently undergoing a five-year stability
analysis. (more) |
Informed consent in
clinical trials of Carraguard
Population Council researchers have actively worked to inform
policymakers, donors, scientists, and others about the need for microbicides. Barbara Friedland, study coordinator for several Carraguard
clinical trials, describes the research the Council has
conducted to enhance trial design, to involve communities in
clinical studies, and to improve informed consent processes for
trial participants. (more) |
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Clinical
trial informed consent video
This video, produced by the Population Council, was shown to potential
participants in the clinical trial testing the efficacy of Carraguard.
It was carefully designed and tested to ensure truly informed consent
and voluntary participation. (more)
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Clinical testing of
Carraguard
After basic science research and product development, Population Council
scientists conducted human clinical trials of its candidate microbicide
formulations. They tested the products’ safety and acceptability in Phase
1 and 2 trials on six continents. In a Phase 3 clinical trial with
6,000 women in South Africa, the Council tested the long-term
safety of Carraguard and its efficacy in preventing HIV
infection. During that and
all phases of testing, study participants have been encouraged to use
condoms during each sexual act. (more) |
See Also
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Articles on microbicides from Population Briefs
(full
text)
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"Developing and
testing a gel to prevent HIV transmission," from
Population Council 2004 Annual Report (full
text)
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