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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00116415 |
The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.
Condition | Intervention |
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HIV Infections AIDS |
Drug: efavirenz; didanosine EC; lamivudine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Daily Antiretroviral Therapy (DART 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients |
Estimated Enrollment: | 65 |
Study Start Date: | March 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Local Institution | |
Washington, District of Columbia, United States | |
United States, Florida | |
Local Institution | |
Orlando, Florida, United States | |
United States, Georgia | |
Local Institution | |
Columbus, Georgia, United States | |
United States, Massachusetts | |
Local Institution | |
Boston, Massachusetts, United States | |
Local Institution | |
Springfield, Massachusetts, United States | |
United States, Missouri | |
Local Institution | |
Kansas City, Missouri, United States | |
United States, New Jersey | |
Local Institution | |
Hillsborough, New Jersey, United States | |
United States, New York | |
Local Institution | |
Bronx, New York, United States | |
United States, Texas | |
Local Institution | |
Dallas, Texas, United States |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | AI266-071 |
Study First Received: | June 29, 2005 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00116415 |
Health Authority: | United States: Institutional Review Board |
HIV/AIDS |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Didanosine HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |