Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122577
Status:
TERMINATED
Last Update Posted:
2005-07-28
First Post:
2005-07-19
Brief Title:
Efficacy and Safety of Tenofovir DFAtazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients
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:
Randomized Open Label Study Assessing the Antiviral Activity Toxicity and Pharmacologic Interaction of Tenofovir DFAtazanavir Enhanced With Low Dose of Ritonavir as Part of a Salvage Regimen in HIV Infected Patients With Multiple Treatment Failures ANRS 107 Trial PUZZLE 2
Status:
TERMINATED
Status Verified Date:
2005-07
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:
This trial is aimed at studying the antiviral activity toxicity and pharmacokinetic PK interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to HIV patients with multiple failure under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir
Detailed Description:
When licensed new drugs are widely used in patients failing antiretroviral therapy including patients with multiple failures In such patients having multi-resistant virus the introduction of one new drug only in the salvage regimen will infrequently result in undetectable virus load in the plasma Tenofovir DF and atazanavir appear promising because of their pharmacokinetic profile activity safety and resistance properties In addition pharmacokinetic data in healthy volunteers suggest that atazanavir could be optimized by adding ritonavir at low dose Thus one may speculate that atazanavir pharmacokinetic and antiviral activity could be optimized by adding ritonavir at low dose in patients exhibiting high rate of protease inhibitor mutations
This protocol is aimed at studying the antiviral activity toxicity and PK interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to patients with multiple failure under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir
EKG abnormalities increased PR and QTc intervals were observed in normal volunteers treated with atazanavir therefore EKG safety monitoring will be performed on all subjects during this study
This protocol is aimed at studying the antiviral activity toxicity and PK interactions of tenofovir DF and atazanavir enhanced with low dose of ritonavir given alone and then concomitantly as part of a salvage regimen to patients with multiple failure under conditions allowing to tease out the specific role of atazanavir combined with low dose of ritonavir
EKG abnormalities increased PR and QTc intervals were observed in normal volunteers treated with atazanavir therefore EKG safety monitoring will be performed on all subjects during this study
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