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

Completed · Phase 3

Conditions studied: HIV Infection, Infection, Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT00363142

Run by

GlaxoSmithKline

People needed

211

Starts

2006-05-01

Expected to finish

2008-06-01

Last updated by the study team

2010-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with HIV-1 infection.
• Are willing and able to understand and provide written consent prior to participation in this study.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — West Hollywood, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Oakland Park, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Sarasota, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Macon, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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