Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002417
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Amprenavir in Patients With Protease Inhibitor-Related Complications
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
1999-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRO30012 | None | None | None |