The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Hoffmann-La Roche
• Treatments: Ritonavir; Saquinavir

Criteria

Inclusion Criteria:

• HIV infected woman

• 18 - 40 years of age

• able and willing to sign Informed Consent

• pregnant for a maximum of 31 weeks

Exclusion Criteria:

• history of sensitivity/idiosyncrasy to the drug

• relevant history of interference with drug metabolism

• inability to understand trial procedures

• abnormal specific serum levels

• use of specific concomitant medications

• active hepatobiliary or hepatic disease

• previous failure of saquinavir/ritonavir regimen