Pharmacokinetics of Low Dose Ritonavir

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare the Pharmacokinetics of ritonavir and saquinavir(using either Saquinavir /Ritonavir 1500/100 mg or 1500/50 mg) Evaluate short term tolerability, safety and toxicity Evaluate if there is any relation between RTV concentration levels and boosting effect

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

Details

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

Criteria

Inclusion Criteria:

• Age > 18 years

• Documented positive test for HIV-1 infection

• HIV RNA viral load 50 < copies for at least 3 months

• Written informed consent

• On a Saquinavir 1500 mg based HAART regimen for at least 3 months

Exclusion Criteria:

• Pregnant or lactating

• Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir/ritonavir

• Inability to understand the nature and extent of the study and the procedures required

• ALT/ AST more than 5x upper limit

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