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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 57 Study Locations| Study Chair: | Juan Berenguer Berenguer, MD | Hospital Gregorio Marañón |
More Information
| ClinicalTrials.gov Identifier: | NCT00256828 History of Changes |
| Other Study ID Numbers: | GESIDA-3903 |
| Study First Received: | November 21, 2005 |
| Last Updated: | October 15, 2007 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
HIV infection Highly active antiretroviral therapy Treatment Naive |
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Didanosine Zidovudine |
Lamivudine Efavirenz Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |