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Sponsored by: |
Hospital Clinic of Barcelona |
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Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00532168 |
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
Design:
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: tenofovir + emtricitabine + efavirenz Drug: tenofovir + emtricitabine + lopinavir-ritonavir Drug: tenofovir + emtricitabine + atazanavir-ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Once-Daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study. |
Estimated Enrollment: | 108 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
tenofovir plus emtricitabine plus efavirenz
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Drug: tenofovir + emtricitabine + efavirenz
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
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2: Experimental
tenofovir plus emtricitabine plus lopinavir-ritonavir
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Drug: tenofovir + emtricitabine + lopinavir-ritonavir
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
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3: Experimental
tenofovir plus emtricitabine plus atazanavir-ritonavir
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Drug: tenofovir + emtricitabine + atazanavir-ritonavir
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jose M Miró, MD | oo34932275430 | jmmiro@clinic.ub.es |
Spain, Catalonia | |
Hospital Clinic | Recruiting |
Barcelona, Catalonia, Spain, 08036 | |
Principal Investigator: Jose M Miró, MD |
Study Chair: | Jose M Miró, MD | Hospital Clinic Barcelona |
Responsible Party: | Hospital Clinic, Barcelona ( Josep M Miró ) |
Study ID Numbers: | ADVANZ-3, EudraCT: 2006-006268-42, FIS grant: EC07/90642 |
Study First Received: | September 18, 2007 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00532168 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
advanced HIV-infected patients late presenters antiretroviral therapy immune reconstitution Treatment Naive |
Anti-Infective Agents Efavirenz HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Atazanavir Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors |
Virus Diseases Anti-Retroviral Agents Emtricitabine Lopinavir HIV Infections Ritonavir Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Lopinavir Emtricitabine Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil Efavirenz |
RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Ritonavir HIV Infections Sexually Transmitted Diseases |