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| Sponsors and Collaborators: |
Hospital Clinic of Barcelona Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Germans Trias i Pujol Hospital Hospital Universitari Joan XXIII de Tarragona. Hospitales Universitarios Virgen del Rocío |
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| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00759070 |
Purpose
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Tenofovir + emtricitabine + efavirenz Drug: Tenofovir + emtricitabine + lopinavir/ritonavir |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-Naive HIV-Infected Subjects |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
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Drug: Tenofovir + emtricitabine + efavirenz
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)
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2: Active Comparator
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
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Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Esteban Martinez, MD | +34932275400 ext 3310 | esteban@fundsoriano.es |
| Contact: Felipe Garcia, MD | +34932275586 | fgarcia@clinic.ub.es |
| Spain | |
| Hospital Clinic | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Esteban Martinez, MD esteban@fundsoriano.es | |
| Contact: Felipe Garcia, MD fgarcia@clinic.ub.es | |
| Principal Investigator: Esteban Martinez, MD | |
| Principal Investigator: Felipe Garcia, MD | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Pere Domingo, MD +34932919343 pdomingo@hsp.santpau.es | |
| Principal Investigator: Pere Domingo, MD | |
| Hospital Universitario Virgen del Rocío | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact: Manuel Leal, MD mleal@telefonica.es | |
| Principal Investigator: Manuel Leal, MD | |
| Hospital Joan XXIII | Recruiting |
| Tarragona, Spain, 43007 | |
| Contact: Francesc Vidal, MD fvidal@comt.es | |
| Principal Investigator: Francesc Vidal, MD | |
| Spain, Barcelona | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Eugenia Negredo, MD +34934655374 | |
| Principal Investigator: Eugenia Negredo, MD | |
More Information
| Responsible Party: | Hospital Clinic of Barcelona ( Josep Mª Gatell Artigas ) |
| Study ID Numbers: | LIPOTAR-07, EudraCT number: 2007-002698-29 |
| Study First Received: | September 23, 2008 |
| Last Updated: | October 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00759070 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
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Treatment Naïve |
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Anti-Infective Agents Efavirenz HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome 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 |
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Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Lopinavir Emtricitabine Anti-Retroviral Agents 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 Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Ritonavir HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
