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Sponsored by: |
Clinical Trial Agency of HIV Study Group |
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Information provided by: | Clinical Trial Agency of HIV Study Group |
ClinicalTrials.gov Identifier: | NCT00256828 |
The purpose of this study is to compare the antiviral activity of two treatment groups for HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the starting treatment of human immunodeficiency virus infection at Week 48.
Condition | Intervention | Phase |
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HIV Infections |
Drug: didanosine + lamivudine + efavirenz |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Open Label, Clinical Trial Comparing a QD Regimen of Didanosine, Lamivudine and Efavirenz With a Standard BID Regimen of Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of Human Immunodeficiency Virus Infection (GESIDA 39/03) |
Estimated Enrollment: | 360 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subjects should provide the baseline laboratory values measured during the 4 weeks prior to the start of the study drugs, specified below:
Exclusion Criteria:
Study Chair: | Juan Berenguer Berenguer, MD | Hospital Gregorio Marañón |
Study ID Numbers: | GESIDA-3903 |
Study First Received: | November 21, 2005 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00256828 |
Health Authority: | Spain: Spanish Agency of Medicines |
HIV infection Highly active antiretroviral therapy Treatment Naive |
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Didanosine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases 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 |