Safety Of VIRACEPT® 625mg Administered To HIV-Infected Women During Pregnancy

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is an evaluation of the safety of 625 mg formulation when administered to HIV-infected pregnant women from their second trimester through six weeks postpartum. The study will also evaluate the pharmacokinetics of VIRACEPT

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Lamivudine, zidovudine drug combination; Nelfinavir

Criteria

Inclusion Criteria:

• HIV infection

• Second trimester of pregnancy

Exclusion Criteria:

• Major current or prior history of obstetrical complications

• Serious current medical diseases

• Evidence of HIV virus resistance to antiretroviral agents