A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications

Inclusion Criteria Patients must have: Documented HIV-1 infection. Two consecutive (at least 4 weeks apart) screening HIV-1 plasma RNA levels less than or equal to 10,000 copies/ml prior to open-label drug administration. Hyperlipidemia with or without lipodystrophy (Grade 1-4 toxicity for triglycerides or total cholesterol), be intolerant to standard protease inhibitor therapy and, in the judgment of the physician, be unable to construct a viable treatment regimen without APV. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Renal failure requiring dialysis. Hepatic failure. Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction which, in the opinion of the investigator, would compromise the safety of the patient. Malabsorption syndrome or other gastrointestinal dysfunction, which might interfere with drug absorption or render the patient unable to take oral medication. Concurrent Treatment: Excluded: Concomitant use of another protease inhibitor. Patients with the following prior condition are excluded: Clinically relevant history of pancreatitis or hepatitis within the last 6 months. Prior Treatment: Excluded: Previous treatment with APV. Risk Behavior: Excluded: Patients currently using alcohol or illicit drugs which, in the investigator's opinion, may interfere with the patient's ability to comply with the requirements of the study. Included: Prior treatment with at least one protease inhibitor.