Viewing Study NCT00528060


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Study NCT ID: NCT00528060
Status: COMPLETED
Last Update Posted: 2011-12-22
First Post: 2007-09-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Organization:

Study Overview

Official Title: Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3
Status: COMPLETED
Status Verified Date: 2011-12
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: ANRS134COPHAR3
Brief Summary: the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Detailed Description: The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.

Study Oversight

Has Oversight DMC: True
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?: