Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Lamivudine, zidovudine drug combination; Ritonavir

Criteria

Inclusion Criteria:

• HIV-infected pregnant women

• > 18 years of age

• Between week 12 and 32 gestation

• CD4 > 200 cells/mm³

• Treatment-naive with HIV RNA > 400 c/mL, on HAART with HIV RNA <50 c/mL, or previously treated with ATV (< 3 weeks) with HIV RNA>400 c/mL