For Immediate Release: July 25, 2007
Media Contact: Annette Larkin, 202.429.4929
Email: annettelarkin@rationalpr.com
FINAL HIV RESULTS OF USHERCELL TRIALS PRESENTED AT IAS CONFERENCE
IN
Final
analysis of the data from the CONRAD study showed that the difference in HIV
seroconversions between the CS group and the placebo group was not
statistically significant. There were more seroconversions in the CS group, but
the difference was not large enough to exclude the possibility that it could
have occurred by chance. Out of 1,425 women who were enrolled in the trial, 41
seroconverted — 25 using CS and 16 on the placebo.
A further exploratory analysis using a subset of the data that
excluded women after they stopped using the gel — for example, because of
pregnancy — showed that there were more infections among women using CS than
there were among those using the placebo product, and that difference was
statistically significant. In this secondary analysis, there were 34
seroconversions —23 among those using CS and 11 among those using the placebo.
This alternative analysis suggests that the use of CS gel may increase a
woman’s susceptibility to HIV infection. However, in a study conducted by
Family Health International (FHI) and collaborating investigators in
Taken together, these analyses confirm that CS is not effective
against HIV infection. In order to try to find a scientific explanation for the
higher number of seroconversions in the cellulose sulfate group in one of the
two studies, CONRAD will support a number of activities over the next six
months: additional analyses on the datasets from these two Phase III trials,
additional data gathering in ongoing animal studies of CS, additional in
vitrotesting,
and initiation of a small study in women at two U.S. sites to
explore specific vaginal responses to
CS.
Dr. Van Damme said, “The well being of the women who participate
in clinical trials is, and always will be, our top priority, and we made the
right decision to err on the side of caution when we halted the trial in
January.” Ushercell had undergone 11 safety and tolerance trials prior to the
start of the Phase III trials to determine whether it might be effective at
preventing HIV in humans. “While we are disappointed that cellulose sulfate was
not found to be effective for HIV prevention,” Dr. Van Damme continued,
“with a globally devastating epidemic such as HIV, it is crucial to
continue to evaluate a variety of potential prevention methods, particularly
those that are female-initiated.”
Each new infection that occurred during the trials must be viewed
in the context of a truly devastating pandemic. The studies were conducted in
countries and communities hard-hit by the HIV epidemic. In
During the course of the trials, each woman received medical care,
HIV/STI prevention counseling, and free condoms to help her avoid contracting
HIV. Women who nevertheless tested HIV-positive during these studies also have
been assured access to HIV care and antiretroviral treatment when needed.
CONRAD is a cooperating agency of the U.S. Agency for
International Development (USAID) committed to improving reproductive health by
expanding the contraceptive choices of women and men and by helping to prevent
the transmission of HIV and other sexually transmitted infections. CONRAD is
administered through the Department of Obstetrics and Gynecology at Eastern
Virginia Medical School (EVMS) in
Family Health International (FHI) is a nonprofit organization
dedicated to improving lives, knowledge, and understanding worldwide through a
highly diversified program of research, education, and services in family
health and HIV/AIDS prevention and care. Since its inception in 1971, FHI has
formed partnerships with national governments and local communities in
countries throughout the developing world to support lasting improvements in
the health of individuals and the effectiveness of entire health systems. FHI
has 1700 staff and offices in 40 countries. www.fhi.org
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For more information, contact:
Family Health International: Beth Robinson, Deputy Director for
Research Dissemination,
