This is an open label Phase I study. At least 10 HIV-infected pregnant women between 14 and 28 weeks gestation will be enrolled. The women will receive triple combination therapy with indinavir, 3TC, and ZDV during the antepartum period, discontinue indinavir at the start of the intrapartum period while continuing 3TC, and ZDV, and restart indinavir, 3TC and ZDV during the post partum period thru the first 12 postpartum weeks. The mother and her primary care physicians will decide if the mother will continue the same regimen after 12 weeks post partum. The infant will receive 3TC and ZDV at birth and for six weeks following birth. Pharmacokinetic evaluations on cervical secretions and plasma will be performed at the antepartum, intrapartum, and postpartum visits in the women and postnatally in the infants. Baseline and study safety evaluations will include the monitoring of adverse experiences, clinical laboratory tests, physical examinations and vital signs. Temporarialy closed to enrollment awaiting FDA approval for modification.

Project Start
2000-12-01
Project End
2001-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
2001
Total Cost
$155,764
Indirect Cost
Name
Baylor College of Medicine
Department
Type
DUNS #
074615394
City
Houston
State
TX
Country
United States
Zip Code
77030
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