A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002417
- Run by
- Glaxo Wellcome
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Glaxo Wellcome Inc — Research Triangle Park, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.