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What does the Population Council do?
- The Population Council is an international, not-for-profit,
nongovernmental organization that conducts biomedical, social
science, and public health research on global issues, including
HIV and AIDS; poverty, gender, and youth; and reproductive health.
- Founded in 1952 and headquartered in New York, the Population
Council employs more than 500 people, has offices in 19 developing
countries in Africa,
Asia, and the Americas, and conducts research in more than 60
countries.
The pandemic of HIV and AIDS
- The number of people living with HIV is now higher than ever:
Approximately 39.5 million people worldwide are HIV-positive. In 2006,
more than 4 million were newly infected, and the epidemic claimed an
estimated 2.9 million lives.
- Global statistics show that nearly half of adults living with HIV
are women.
- Gender-based power imbalances fuel the feminization of AIDS.
- Women are mobilizing to fight HIV and care for those affected by
AIDS on every continent. Women are leading efforts to improve women’s
social and economic status.
HIV and AIDS in sub-Saharan Africa
- In 2006, almost two-thirds of all people living with HIV were
residing in sub-Saharan Africa.
- An estimated 2.8 million people in sub-Saharan Africa became
infected with HIV in 2006, more than in all other regions of the
world combined.
- The latest survey data underscore the disproportionate impact
of the AIDS epidemic on women and girls in sub-Saharan Africa. They are
more likely to be living with HIV and more likely to be caregivers
for other HIV-positive people.
- In sub-Saharan Africa young women are about three times more
vulnerable to HIV infection than young men.
- Sixty-one percent of people living with HIV in sub-Saharan Africa
are women, who are at greater risk of HIV infection than men for a
range of biological and sociocultural reasons.
- For every 10 adult men living with HIV, 14 adult women live with
the virus.
- Almost one in 10 children have lost one or both parents to AIDS.
HIV and AIDS in South Africa
As of 2006:
- There have been 1.8 million AIDS deaths in South Africa.
- Seventy-one percent of all deaths in the 15–49 age group were due to AIDS.
- Approximately 230,000 HIV-infected individuals were receiving
antiretroviral treatment; an additional 540,000 were sick with AIDS
but were not receiving antiretroviral treatment.
- 300,000 children under the age of 18 experienced the death of
their mother.
- 1.5 million children under the age of 18 were maternal or double
orphans (i.e., had lost their mother or both parents), and 66% of these
children had been orphaned as a result of HIV and AIDS.
- Around 740,000 deaths occurred, of which 350 000 were due
to AIDS (approximately 950 AIDS-related deaths per day).
The Population Council and HIV
and AIDS
- The Population Council has a comprehensive approach to HIV
prevention, support, and treatment. In
high-prevalence areas, Council researchers work to understand the
individual, social, and economic circumstances that influence
whether people engage in safe sex, learn their HIV status, and seek
care. Major biomedical initiatives include studying the role of the
immune system in the spread of HIV, which may lay the groundwork for
a vaccine, and developing microbicides to prevent sexual
transmission of infection. The Council also seeks to reduce the consequences of the pandemic,
strengthen health systems, and inform policy decisions. For more
information, visit
www.popcouncil.org/hivaids.
- The organization is committed to combating the underlying causes
of the AIDS pandemic, such as gender inequity, poverty, and
low-quality, hard-to-access health services.
- More than 32 percent of the Population Council's direct program
expenditures focus on HIV and AIDS prevention, treatment, and care
activities.
The Population Council in South Africa
- The Population Council has been working in Africa since the 1960s and in
South Africa for nearly a decade. The organization has offices in
Johannesburg and ten other African cities. During the past decade, the Council has worked on
projects in 25 African countries.
- Population Council programs in South Africa include providing
social science research training, encouraging men’s participation in
the health and welfare of their partners and children, strengthening
the quality of services for rape victims, reducing nursing staff
turnover at public health facilities, and assessing the value of
youth centers as a means of providing reproductive health services.
Visit our South Africa pages for an overview of the organization’s work
there.
- The Council’s South African collaborators have included Nelson
Mandela's Children's Fund's Goelama Project; the departments of
Education, Health, and Social Development & Welfare; Eskom;
mothers2mothers, the Salvation Army; Save the Children; Development
Research Africa; and many others.
The Population Council and microbicides
development
- Vaginal microbicides are being developed as a female-initiated
method for reducing male-to-female transmission of HIV, and possibly
other sexually transmitted infections (STIs), when used during sex.
They would most likely be formulated as vaginal gels, creams, foam,
or rings.
- Women urgently need more HIV prevention options because the
current strategies—abstinence, being faithful, condoms, and STI
treatment—often are not feasible.
- The first microbicide on the market probably will not work as
well as condoms, which are highly (80%–95%) effective for preventing
sexual transmission of HIV when used consistently and correctly.
Even a partially effective microbicide, however, could have a
substantial impact on the AIDS pandemic, particularly for women for
whom condom use is not always possible.
- The Population Council’s first-generation candidate microbicide
was Carraguard®, an odorless, colorless, tasteless,
carrageenan-based vaginal gel. It was the first product developed as
a microbicide to have completed a Phase 3 trial without any safety
concerns.
- Research by the Population Council and independent testing
facilities demonstrated that Carraguard is effective in blocking HIV
transmission in laboratory studies.
- In five studies prior to the Phase 3 trial, Carraguard and
similar carrageenan formulations were found to be safe for vaginal
use and acceptable to both HIV-negative and HIV-positive women and
men. More than 850 people participated in those studies, which were
conducted on six continents including in Australia, Chile, the
Dominican Republic, Finland, South Africa, Thailand, and the United
States.
Carraguard Phase 3 clinical
trial: Background
- The Population Council sponsored the Carraguard Phase 3 trial to
evaluate its safety when used during a two-year period and its
efficacy for preventing male-to-female transmission of HIV.
- The Phase 3 Carraguard trial was conducted in South Africa
because vaginal microbicide efficacy trials must be conducted where
there are high rates of HIV infection and where HIV is spread
primarily through heterosexual sex so that scientists can determine
whether or not the product prevents infection.
- The 6,202 women who participated in the trial were randomly
assigned to a study group: half received Carraguard and the other
half received a placebo. Neither the volunteers nor the study staff
knew who was using which gel.
- As part of ongoing HIV risk-reduction counseling, women were
given condoms and counseled to use them with the study gel each time
they had (vaginal) sex because (1) condoms currently are the
best-known method of preventing HIV transmission during sex; (2) it
was not known whether Carraguard prevents HIV transmission; and (3)
half of the women received a "comparison gel" or placebo, which has
not been shown to prevent transmission of HIV.
- The Phase 3 study was reviewed and approved by the ethics
committees (groups making sure that participants are treated
properly in research) at each collaborating institution: the
Population Council Institutional Review Board, the University of
KwaZulu-Natal Biomedical Research Ethics Committee, the University
of Cape Town Research Ethics Committee, and the University of
Limpopo Research Ethics and Publications Committee (REPC). The trial
also was reviewed and approved by the Medicines Control Council
(MCC), the regulatory agency in South Africa, and was submitted to
the US Food and Drug Administration.
- An external, independent panel of experts called a Data Safety
Monitoring Board (DSMB) reviewed study data three times during the
trial and judged that there were no significant safety risks to
study participants, so the trial continued to its scheduled
completion.
- All trial volunteers took part in an extensive informed consent
process, which included a video and other educational materials. The
importance of condom use, the unknown efficacy of the gel, and the
fact that half of the women had a placebo were emphasized in all
materials, which were available in three local languages in addition
to English: Zulu at the Durban site, Xhosa at the Cape Town site,
and Setswana at the Medunsa site.
- In collaboration with Community Advisory Groups, informed
consent procedures were developed that allowed women interested in
the trial to make truly informed decisions about whether or not to
join. Community feedback was incorporated into trial outreach
materials, informed consent forms, study booklets, and a video.
Regular community meetings during the trial provided a forum for
discussions, where concerns could be aired and discussed.
- Women who tested HIV-positive at screening and women who became
infected while participating in the trial were referred to medical,
psychological, and supportive services in the community. Some sites
offered CD4 count, nutritional counseling, physician check-ups, and
support groups.
- The Population Council provided funding to the trial sites to
help support medical and psychological referral services for
HIV-positive women.
Carraguard Phase 3 clinical trial:
Study results
- The Phase 3 clinical trial of the Population Council’s candidate
microbicide Carraguard did not show that Carraguard is effective in
preventing HIV transmission during vaginal sex.
- Carraguard was shown to be safe for use during vaginal sex over
a two-year period.
- The Carraguard Phase 3 trial is a milestone for microbicides
development; it is the first Phase 3 trial of a candidate microbicide to be
completed without any safety concerns.
- Because Carraguard is safe and acceptable, the Population
Council is now examining whether Carraguard combined with other
ingredients is effective in preventing the transmission of HIV.
- The safety of the participants in the Carraguard trials was the
top priority of researchers and donors. More than 6,000 trial
participants received high-quality sexual and reproductive health
care and education free of charge, as well as regular testing and
treatment for sexually transmitted infections, safer-sex counseling,
HIV testing, and pelvic exams, all of which contribute to reduced
risk of HIV infection.
Product development and the Population
Council's plans for further microbicide development
- Before drugs and other health products are available to the
public, they must go through a rigorous testing process—first in
laboratory and animal studies, then in humans—to ensure safety and
efficacy. Only one in five drugs entering human clinical trials ever
makes it to market.
- Product development typically takes more than ten years from the
time a promising compound is identified in the laboratory until
eventual marketing.
- Population Council research on future candidate microbicides
includes a range of formulations and delivery methods. The
Population Council’s microbicides program includes plans to continue
improving gel-based candidates for women to use regularly or just
when having sex.
- The Council will continue microbicide development as part of an
overall effort to achieve our mission of improving the well-being
and reproductive health of current and future generations around the
world.
Sources
International Center for Research on Women (ICRW). 2006. "Quick
facts,
women: The new face of AIDS." Washington, DC: ICRW.
South African National AIDS Council (SANAC). 2007. "HIV & AIDS and STI
Strategic Plan for South Africa: 2007–2011." Pretoria: SANAC.
UNAIDS. 2006. "AIDS epidemic update: Special report on HIV/AIDS: December 2006."
Geneva: UNAIDS and WHO.
Contact: microbicide@popcouncil.org
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