A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications
|First Submitted Date ICMJE||November 2, 1999|
|First Posted Date ICMJE||August 31, 2001|
|Last Update Posted Date||December 9, 2005|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications|
|Official Title ICMJE||An Open-Label Study to Evaluate the Safety and Tolerance of Amprenavir (141W94) Combination Therapy in Protease Inhibitor Experienced Subjects Who Are Intolerant (Hyperlipidemia With or Without Lipodystrophy) But Not Failing Their Current Protease Inhibitor Therapy|
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.
Protease inhibitors are highly efficacious in the treatment of HIV-1 disease. Current drugs, however, are associated with a high incidence of adverse effects as well as metabolic complications such as lipodystrophy and hyperlipidemia. At the same time, though, a causal relationship linking these complications to the use of protease inhibitors remains to be established. Studies have shown APV to be well tolerated and effective in reducing plasma HIV-1 RNA levels. The safety profile of APV suggests it may offer therapeutic potential in subjects developing intolerance to other protease inhibitors.
Patients receive open-label APV plus at least 2 other antiretroviral drugs. Fasting blood samples and patient medication adherence questionnaires are collected at Weeks 12 and 24. Bodily assessments are collected at Day 1 and Weeks 12 and 24. Hematology, serum chemistry, plasma HIV-1 viral load determination and CD4+ cell count measurements are collected at pre-entry and every 12 weeks for the duration of the study.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Primary Purpose: Prevention|
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Amprenavir|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must have:
Patients with the following symptoms and conditions are 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.
Previous treatment with APV.
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.
Prior treatment with at least one protease inhibitor.
|Ages||13 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00002417|
|Other Study ID Numbers ICMJE||264J
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Glaxo Wellcome|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||NIH AIDS Clinical Trials Information Service|
|Verification Date||April 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP