[afro-nets] Cameroon Tenofovir Study Closure

[David Hock <DHock@fhi.org>]

Cameroon Tenofovir Study Closure
--------------------------------

Family Health International, in Conjunction with the Ministry of
Public Health, to Conclude Research on Oral Tenofovir at Camer-
oon Study Site

July 29, 2005

YAOUNDE, CAMEROON and RESEARCH TRIANGLE PARK, NC, USA

Nearly a year ago, Family Health International (FHI), in col-
laboration with global partners, began conducting a study to see
if a widely-used oral HIV treatment drug could safely prevent
acquisition of HIV infection. Women enrolled in the study in
Cameroon and other sites were randomized to receive the drug,
called tenofovir, plus condoms and HIV risk-reduction counsel-
ing, or a placebo, plus condoms and counseling. In conjunction
with the Ministry of Public Health of Cameroon, FHI is now for-
mally closing the Cameroon study after five months of suspen-
sion.

During the suspension period, the team was allowed to continue
to provide medical and counseling services to study partici-
pants, but not to provide the study drug. One of the major rea-
sons for the suspension was the need to work out a system for
the site to ensure long-term treatment for any participant who
became infected with HIV during the trial. This important inter-
national issue -- how to access long-term HIV treatment for par-
ticipants in research - is still being discussed by interna-
tional and national agencies in many venues, including one held
recently at UNAIDS in Geneva.

While important safety information has been learned from the
study, so much time has elapsed with participants not being able
to receive the study drug that the data will not be able to de-
termine the effectiveness of tenofovir in preventing HIV acqui-
sition.

Over the next month, women will return to the clinic for their
final visits. By the end of September 2005, the site will be
closed. FHI will ensure that the five women who have become HIV-
infected while enrolled in the tenofovir study in Cameroon will
have long-term access to HIV/AIDS state-of-the-art care and
treatment, as defined by the Cameroon National AIDS Control Pro-
gram.

Safety data on use of oral tenofovir for HIV prevention was ob-
tained from the Cameroon study, and will be combined with data
from the other sites to answer safety questions on this poten-
tial HIV prevention drug. Building partnership with the commu-
nity and media is a key issue in conducting preventive research
on HIV/AIDS.

FHI and the Ministry of Public Health of Cameroon will continue
to collaborate in HIV preventive research and other crucial pub-
lic health issues.

For more information, please mailto:media@fhi.org


--
David Hock
mailto:DHock@fhi.org