The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: International Antiviral Therapy Evaluation Center; Kirby Institute; Roche Pharma AG
• Treatments: HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Ritonavir; Saquinavir

Criteria

Inclusion Criteria:

1. written informed consent

2. ARV-naïve

3. HIV-1 infected Thai male or female > 18 years old

4. Documented positive test for HIV-1 infection

Exclusion Criteria:

1. Inability to understand the nature and extent of the study and the procedures required.

2. Pregnancy or lactating

3. Active opportunistic infection

4. ALT/ AST more than 2x upper limit

5. creatinine more than 1.5 time the upper limit

6. Smoke cigarettes more than 10 cigarettes a day.

7. Drink alcohol more than 2 units a day

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

9. Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir