Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002245
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of the Effects of Amprenavir a Protease Inhibitor on Carbohydrate and Fat Metabolism in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
2000-08
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 evaluate the effects of a 3-drug anti-HIV regimen amprenavir APV plus abacavir ABC plus lamivudine 3TC on the way carbohydrates sugars and fats are metabolized processed by the body in HIV-infected patients who have received little or no previous anti-HIV drug therapy
Detailed Description:
This single-site study uses an open-label single-arm design to evaluate the effects of APV a protease inhibitor PI plus concurrent nucleoside reverse transcriptase inhibitors NRTIs ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic HIV-1 infected patients initiating antiretroviral therapy Treatment duration is 24 weeks and patients serve as their own controls The combination therapy is evaluated for safety tolerability efficacy and effects on body composition The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor less than 400 copiesml and Ultrasensitive less than 50 copiesml is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC
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 |
|---|---|---|---|
| COL30309 | None | None | None |