Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002205
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir 141W94 and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir 141W94 and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects With HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen
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:
To assess the safety tolerance and efficacy of amprenavir APV plus abacavir ABC in patients who have previously failed antiretroviral treatment containing a protease inhibitor PI To provide open-label pre-approval access to APV for adults and adolescents with HIV-1 infection and limited treatment options
This study is being conducted to provide open-label APV to patients in danger of HIV disease progression as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies Despite unapproved status APV may prove highly efficacious in combatting HIV progression and may help those in need prior to regulatory approval
This study is being conducted to provide open-label APV to patients in danger of HIV disease progression as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies Despite unapproved status APV may prove highly efficacious in combatting HIV progression and may help those in need prior to regulatory approval
Detailed Description:
This study is being conducted to provide open-label APV to patients in danger of HIV disease progression as well as those who may benefit beyond the expected outcomes of current anti-retroviral therapies Despite unapproved status APV may prove highly efficacious in combatting HIV progression and may help those in need prior to regulatory approval
Patients are stratified into one of the following treatment options
Non-nucleoside reverse transcriptase inhibitor NNRTI-naive
Option 1- APV ABC PI NNRTI nucleoside reverse transcriptase inhibitors NRTI Option 2- APV ABC NNRTI NRTIs
NNRTI-Experienced Patients
Option 1- APV ABC PI NRTIs Option 2- APV ABC NRTIs To assess clinical efficacy lab values ie hematology serum chemistry plasma HIV-1 viral load determination and CD4 cell count measurements are collected at pre-entry and every 12 weeks thereafter
Patients are stratified into one of the following treatment options
Non-nucleoside reverse transcriptase inhibitor NNRTI-naive
Option 1- APV ABC PI NNRTI nucleoside reverse transcriptase inhibitors NRTI Option 2- APV ABC NNRTI NRTIs
NNRTI-Experienced Patients
Option 1- APV ABC PI NRTIs Option 2- APV ABC NRTIs To assess clinical efficacy lab values ie hematology serum chemistry plasma HIV-1 viral load determination and CD4 cell count measurements are collected at pre-entry and every 12 weeks thereafter
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?: