NIAID's Review of HIVNET 012
On Friday March 22 the National Institutes
for Allergies and Infectious Diseases (NIAID) released information
regarding the clinical trial HIVNET 012. This trial, conducted
in Uganda, demonstrated the safety and effectiveness of
single-dose Nevirapine for the prevention of mother-to-child
transmission of HIV. During a review of the study, NIAID
found that some of the study's data collection did not conform
to Food and Drug Administration reporting requirements.
The U.S. Agency for International Development
(USAID) agrees with NIAID that this in no way negates the
scientific findings of HIVNET 012. In this and other trials,
Nevirapine has been shown to be safe and effective in preventing
the transmission of HIV from mother to infant. This use
of Nevirapine is also recommended by the U.S. Department
of Health and Human Services, the World Health Organization,
and UNICEF. Therefore, USAID reaffirms its support for the
use of Nevirapine to prevent mother to child transmission
of HIV. USAID is pleased that the manufacturer, Boehringer
Ingelheim, will continue to donate Nevirapine for this purpose.
USAID provides direct support to 10 programs
to prevent mother to child transmission of HIV in Kenya,
Zambia, Rwanda, and Ukraine; and provides indirect support
to other sites in Uganda and South Africa. Many of these
sites use Nevirapine and will continue to do so.
Last year 800,000 infants were born
with HIV infection, making this the second most common cause
of all new HIV infections. The use of Nevirapine is a simple
and effective method to prevent these infections has brought
hope to millions of people around the world. USAID remains
committed to providing access to this intervention in developing
countries.
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