This is a phase III randomized, blinded study of nevirapine vs. nevirapine placebo for the prevention of maternal to fetal transmission in pregnant women who present during the third trimester of pregnancy. Participating mothers will be given a single blinded dose during active labor. Neonates will be given a single dose of nevirapine elixir or placebo elixir by mouth at 2-3 days of life. The primary endpoint is incidence of transmission of HIV infection from mother to fetus. The secondary endpoints are monitoring of maternal and neonatal toxicities, determination of nevirapoine pharmacokinetics in neonates, determinine the relationship between maternal plasma viremia and risk of vertical transmission and the effect on neonate plasma viremia.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000083-37S1
Application #
6264524
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
37
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Type
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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