Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

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

Summary

Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

Inclusion Criteria:

• Written informed consent

• Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs

• HIV RNA < 50 copies/ml

Exclusion Criteria:

• 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.

• Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir

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

• Active drug abuse or heavy alcoholic drinking

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

• Active drug abuse or heavy alcoholic drinking