[afro-nets] Update: FHI Oral Tenofovir Study in Nigeria

[David Hock <DHock@fhi.org>]

Statement on Oral Tenofovir (TDF) Study in Nigeria
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Family Health International
March 11, 2005

International efforts are underway to evaluate a widely used HIV
treatment drug called tenofovir as a tool to prevent HIV in peo-
ple who are at high risk. As part of this initiative, Family
Health International is conducting studies in partnership with
local researchers in four African countries. Conducting clinical
trials is a complex endeavor and requires the ability to comply
with rigorous internationally accepted standards. Even with
skilled personnel and commitment to the goals of a given trial,
not all sites that start clinical trials will be able to com-
plete them for a variety of reasons. Regrettably, the tenofovir
study in Nigeria will not be continuing because FHI has deter-
mined that the study team is not at this point able to comply
with all of the standards that have been established for con-
ducting this study. The ability to meet these standards is
critical for ensuring the safety of participants and the quality
of the data from the study. This decision was made in conjunc-
tion with FHI's external, independent Data and Safety Monitoring
Committee. This decision is a reflection of the particular com-
plexity of this trial, and does not signal an overall lack of
ability to do research in this or other sites in Nigeria.

The tenofovir trials are critical to identifying new HIV preven-
tion tools to reduce the number of individuals who become in-
fected with HIV worldwide. New tools could make an especially
large impact in Africa, where more than 70 percent of all HIV
infections occur. The use of an oral preventive drug would be of
particular benefit to women, who often have difficulty negotiat-
ing condom use. Similar studies of tenofovir are occurring in
other parts of the world, including the United States and Asia.

Despite good faith efforts on the part of local staff to improve
the quality of study implementation, and efforts by FHI through
extensive monitoring and training since the study began, the lo-
cal study team has been unable to maintain the required opera-
tional and laboratory procedures at the level necessary for this
complex study. The safety and health of participants has been
closely monitored. There is no evidence that any participants
were harmed or put at risk as a result of the procedural prob-
lems at the Nigeria site, and there have been no serious medical
problems related to the study drug.

In terminating this trial, FHI has an obligation along with the
investigators to continue to follow up women currently enrolled
in this study for an additional three months. This follow-up pe-
riod will allow for further safety monitoring and for study
staff to explain to the women why the study is being closed.
Trained counselors will continue to provide prevention counsel-
ing and HIV testing during these three months. We will continue
to provide the women with information on reducing HIV risk be-
havior. Study participants will continue to be given condoms to
use during all sexual acts and be provided treatment for sympto-
matic sexually transmitted infections, all measures to reduce
HIV transmission.

FHI will continue this important research in the three other Af-
rican sites where FHI is studying tenofovir (Ghana, Cameroon and
Malawi). We will continue to monitor all research sites closely
for compliance with international research standards, and are
confident that the study protocols are being followed. Should
tenofovir eventually prove effective, FHI is committed to re-
turning the benefits of the research to the communities where we
have conducted it, including Nigeria. We want effective HIV pre-
vention tools to be available to everyone, especially the volun-
teers who have helped by their participation in this study. If
this and other studies prove that tenofovir is safe and effec-
tive for HIV-prevention, Gilead Sciences, the drug's manufac-
turer, will make it available at a no-profit cost in Nigeria and
other countries that have participated in research.

For more information, mailto:media@fhi.org

--
David Hock
mailto:DHock@fhi.org