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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe and effective to give the protease inhibitor (PI) amprenavir (APV) to patients with fat production and distribution problems associated with other PIs.

Protease inhibitors are very effective in treating HIV-1 disease. However, patients who take these drugs often have problems, such as hyperlipidemia (an increased level of fat in the blood) and lipodystrophy (problems with the way fat is produced and distributed in the body). Doctors do not know exactly how PIs are related to these problems. APV has been shown to be safe and effective in lowering plasma viral loads (level of HIV in the blood). APV may be useful for patients who develop complications associated with other PIs.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Amprenavir; HIV Protease Inhibitors; Protease Inhibitors

Criteria

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.