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Sponsored by: |
George Washington University |
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Information provided by: | George Washington University |
ClinicalTrials.gov Identifier: | NCT00632970 |
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada. It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Raltegravir Drug: Lopinavir/Ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy |
Estimated Enrollment: | 80 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Raltegravir: Experimental |
Drug: Raltegravir
1 400mg tablet twice a day
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Lopinavir/Ritonavir: Active Comparator |
Drug: Lopinavir/Ritonavir
2 tablets twice a day
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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:
United States, District of Columbia | |
George Washington University Medical Faculty Associates | |
Washington DC, District of Columbia, United States, 20037 |
Principal Investigator: | Gary Simon, MD, PhD | George Washington University |
Responsible Party: | George Washington University Medical Center ( Gary Simon, MD PhD ) |
Study ID Numbers: | GS001 |
Study First Received: | February 29, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00632970 History of Changes |
Health Authority: | United States: Institutional Review Board |
Raltegravir Lopinavir |
Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors |
Virus Diseases Lopinavir Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Retroviral Agents Lopinavir HIV Infections Ritonavir Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |