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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00116116 |
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.
Condition | Intervention | Phase |
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HIV Infections AIDS |
Drug: efavirenz, stavudine extended release, lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 70 |
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, California | |
Local Institution | |
San Francisco, California, United States | |
Local Institution | |
Bakersfield, California, United States | |
United States, District of Columbia | |
Local Institution | |
Washington, District of Columbia, United States | |
United States, Florida | |
Local Institution | |
Miami, Florida, United States | |
Local Institution | |
Ft. Lauderdale, Florida, United States | |
Local Institution | |
Jacksonville, Florida, United States | |
United States, New York | |
Local Institution | |
New York, New York, United States | |
United States, North Carolina | |
Local Institution | |
Greenville, North Carolina, United States | |
United States, Oklahoma | |
Local Institution | |
Oklahoma City, Oklahoma, United States | |
United States, Texas | |
Local Institution | |
Dallas, Texas, United States |
Study ID Numbers: | AI455-131 |
Study First Received: | June 27, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00116116 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV/AIDS |
Antimetabolites Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |