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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00711009 |
The purpose of this study is to compare the safety, tolerability and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with an HIV-1 integrase inhibitor in antiretroviral naive HIV-1 infected subjects.
Condition | Intervention | Phase |
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HIV Infection |
Drug: lopinavir/ritonavir (LPV/r) Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) Drug: raltegravir (RAL) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized, Open-Label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-Formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects |
Enrollment: | 206 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LPV/r + FTC/TDF: Active Comparator |
Drug: lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC/TDF 200/300 mg QD
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LPV/r + RAL: Experimental |
Drug: lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
Drug: raltegravir (RAL)
RAL 400 mg BID
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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:
Responsible Party: | Abbott ( Barry Bernstein, MD, Global Project Head ) |
Study ID Numbers: | M10-336 |
Study First Received: | July 3, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00711009 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sexually Transmitted Diseases, Viral HIV Protease Inhibitors 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 |
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 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 |