Viewing Study NCT00116116



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00116116
Status: COMPLETED
Last Update Posted: 2011-04-26
First Post: 2005-06-27

Brief Title: DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
Sponsor: Bristol-Myers Squibb
Organization: Bristol-Myers Squibb

Study Overview

Official Title: Daily Antiretroviral Therapy DART-II An Open-Label Single-Arm Prospective Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release d4T XR in Combination With Lamivudine 3TC and Efavirenz EFV Once Daily in Anti-Retroviral Therapy ART Naive HIV-Infected Subjects
Status: COMPLETED
Status Verified Date: 2011-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release d4T XR lamivudine 3TC and efavirenz EFV leads to improved outcomes as measured by viral load CD4 counts adherence safety and tolerability
Detailed Description: None

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