Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002405
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Amprenavir in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Amprenavir 141W94 Open Label Protocol for Subjects With HIV-1 Infection Who Have Experienced Treatment Failure or Are Intolerant to Previous 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 to give amprenavir APV to HIV-infected patients This study also examines the effect APV has on the level of HIV in the blood
Earlier studies have shown that APV is effective in slowing the growth of HIV in the body Patients who have failed previous anti-HIV treatment or who are unable to take other protease inhibitors PIs may benefit from the availability of a new PI such as APV
Earlier studies have shown that APV is effective in slowing the growth of HIV in the body Patients who have failed previous anti-HIV treatment or who are unable to take other protease inhibitors PIs may benefit from the availability of a new PI such as APV
Detailed Description:
Earlier Phase IIIII clinical trials indicate APV is effective in retarding HIV progression in the body Despite these data however the drug has yet to receive regulatory approval At the same time there is an urgent need to grant pre-approval access to specific groups of patients eager to benefit from the anti-HIV potential inherent in APV This study examines the relative effects APV has in patients with prior treatment failure or intolerance to previous protease inhibitor therapy
Patients are seen in the clinic at pre-entry baseline Day 1 and every 4 weeks thereafter Data on current antiretroviral treatment HIV-1 associated conditions and adverse events are collected at every scheduled visit Laboratory values ie hematology serum chemistry plasma HIV-1 viral load and CD4 cell count are collected and assessed at pre-entry and Weeks 12 24 36 and 48 Optimal therapeutic effectiveness dictates the combined use of 2 or more antiretroviral agents in patients failing current antiretroviral therapy APV therefore must be initiated as a component of a treatment regimen that also includes at least one other antiretroviral drug that the patient has not previously received
Patients are seen in the clinic at pre-entry baseline Day 1 and every 4 weeks thereafter Data on current antiretroviral treatment HIV-1 associated conditions and adverse events are collected at every scheduled visit Laboratory values ie hematology serum chemistry plasma HIV-1 viral load and CD4 cell count are collected and assessed at pre-entry and Weeks 12 24 36 and 48 Optimal therapeutic effectiveness dictates the combined use of 2 or more antiretroviral agents in patients failing current antiretroviral therapy APV therefore must be initiated as a component of a treatment regimen that also includes at least one other antiretroviral drug that the patient has not previously received
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?: