Microbicide Planned Trials
CAPRISA 008
CAPRISA 008 is a planned implementation study
in South Africa, which would assess the
feasibility and effectiveness of distributing
tenofovir gel through family planning clinics
in communities where the CAPRISA 004 trial took
place. During this trial, former CAPRISA 004
trial participants and women from these
communities will continue to have access to
tenofovir gel by following either the protocol
of monthly resupply, monitoring and testing
used in the trial, or a new quarterly protocol
at family planning clinics that mirrors service
provision for DMPA (or Depo-Provera) injectable
hormonal contraception. This three-year study
will provide information about implementation,
demonstrating how tenofovir gel could be
provided and monitored in service delivery
settings for “real world” use. The study is
awaiting funding and is planned to begin in
2011.
CAPRISA 009
CAPRISA 009 is a planned treatment outcome and
resistance study that will provide care,
treatment and monitoring for former CAPRISA 004
trial participants who became infected with HIV
while in the CAPRISA 004 trial. The study will
compare treatment outcomes for those who are on
combined antiretroviral treatment that includes
tenofovir with those who are on combined
antiretroviral treatment that does not include
tenofovir. This will help inform use of
tenofovir for prevention and treatment, as well
as treatment options for women who acquire HIV
while using tenofovir gel. The study is
awaiting funding and is planned to begin in
2011.
FACTS 001
FACTS 001 is a planned Phase III study of
safety and effectiveness of 1% tenofovir gel
using the same dosing as CAPRISA 004 (vaginal
gel used before and after sex). It will enroll
3,150 HIV-negative, sexually active women
between the ages of 16 and 30 in South Africa
and Kenya. The trial will provide important
safety data for women ages 16 to 17, filling a
critical gap in knowledge. Pending approvals
and funding, the trial could start enrolling by
mid-2011, with results expected by the end of
2013. The trial will be conducted by the Follow
on Africa Consortium for Tenofovir Studies
(FACTS).
IPM 009
IPM 009 is a planned Phase III effectiveness
trial to determine the safety and efficacy of a
dapivirine vaginal ring (inserted once every
four weeks) in preventing HIV infection in
women. The trial will also gather additional
adherence and acceptability data on the
dapivirine vaginal ring among 6,000 female
participants, ages 18 to 40 in Kenya, Malawi,
Rwanda, South Africa and Zimbabwe. The trial is
planned to start in 2011. More information is
available at www.ipmglobal.org/our-work/research/ipm-009a
and www.ipmglobal.org/our-work/research/ipm-009b.
MTN-018
MTN-018 is being planned as the follow-up study
to VOICE—Vaginal
and Oral Interventions to Control the
Epidemic. MTN-018 will be an open-label
study though which former VOICE trial
participants will be invited to join and if
interested, have access to the study product of
their choosing (gel or tablet, assuming both
methods are effective) for the duration of the
study. The study is expected to conclude before
the end of 2012, and results should be
available early 2013. Assuming that at least
one of the products is found effective in
VOICE, researchers would move forward with
MTN-018. Visit
here for more information.