Pharmacokinetics of Generic Lopinavir/Ritonavir in Pregnant Women

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To investigate the possible influence of pregnancy and duration of pregnancy To determine the antiviral activity and safety of generic lopinavir/ritonavir® Compare pharmacokinetics parameters before and after pregnancy.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Documented positive test for HIV-1 infection

• Subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

• Pregnant for a maximum of 30 weeks at the day of first dosing of study medication

Exclusion Criteria:

• History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial.

• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

• Inability to understand the nature and extent of the trial and the procedures required.

• Abnormal serum transaminases or creatinine, determined as levels being > 3 times upper limit of normal.

• Concomitant use of medications that interfere with Generic lopinavir/ritonavir pharmacokinetics

• Active hepatobiliary or hepatic disease (N.B. chronic hepatitis B/C co-infection is allowed)

• Documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing