Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196625
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Salvage Therapy With Amprenavir Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Study on Safety and Efficacy of Salvage Therapy With Amprenavir Lopinavir and Ritonavir 200 Mgd or 400 Mgd in HIV-Infected Patients in Virological FailureANRS 104 PUZZLE 1
Status:
COMPLETED
Status Verified Date:
2005-09
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:
HIV infected patients are treated with highly active antiretroviral therapy HAART Side effects and the great number of pills reduces adherence to the treatment and induces therapeutic failure In order to maintain efficacy of HAART new combination is evaluated The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mgd or 400 mgd ritonavir together with nucleoside reverse transcriptase inhibitors over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed
Detailed Description:
HIV infected patients are treated with highly active antiretroviral therapy HAART Side effects and the great number of pills reduces adherence to the treatment and induces therapeutic failure In order to maintain efficacy of HAART new combination is evaluated The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mgd or 400 mgd ritonavir together with nucleoside reverse transcriptase inhibitors NRTI over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed 100 patients with CD4 cell count below 300mm3 and plasma HIV RNA over 30000 copiesml are to be included in four groups amprenavir lopinavir NRTI with ritonavir 200 mgd or not patients previously treated by additional ritonavir 200 or 400 mgd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None