A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fosamprenavir; Ritonavir

Criteria

Inclusion criteria:

• Subjects with HIV-1 infection.

• Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria:

• Are pregnant or breastfeeding.

• Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.

• Have certain medical conditions that may make participation unsafe.

• Take medication that may interact with the study medication.

• Have a history of allergy to any of the study drugs or any excipients therein.

• Other inclusion/exclusion criteria to be evaluated by the physician.