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| Sponsor: | Clinical Trial Agency of HIV Study Group |
|---|---|
| Information provided by: | Clinical Trial Agency of HIV Study Group |
| ClinicalTrials.gov Identifier: | NCT00256828 |
Purpose
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 |
|---|---|---|
|
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 |
Show Detailed Description
Eligibility| 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:
Contacts and Locations
Show 59 Study Locations| Study Chair: | Juan Berenguer Berenguer, MD | Hospital Gregorio Marañón |
More Information
| Study ID Numbers: | GESIDA-3903 |
| Study First Received: | November 21, 2005 |
| Last Updated: | October 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00256828 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
HIV infection Highly active antiretroviral therapy Treatment Naive |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral 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 Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |