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| Sponsored by: |
University of Miami |
|---|---|
| Information provided by: | University of Miami |
| ClinicalTrials.gov Identifier: | NCT00654147 |
Purpose
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery rates associated with a Two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Raltegravir and Lopinavir/ritonavir Drug: Raltegravir, emtricitabine, tenofovir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Study to Assess Virologic Suppression and Immune Recovery of Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects |
| Estimated Enrollment: | 44 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Raltegravir 400 mg BID + Lopinavir/ritonavir 400 mg/100 mg BID
|
Drug: Raltegravir and Lopinavir/ritonavir
400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
|
|
B: Active Comparator
Raltegravir 400 mg BID + Emtricitabine 200 mg/tenofovir 300 mg QD
|
Drug: Raltegravir, emtricitabine, tenofovir
400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
|
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects. HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).
Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.
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: Juan Casuso | 305-243-3838 |
| United States, Florida | |
| University of Miami AIDS Clinical Research Unit | Not yet recruiting |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: Margaret A Fischl, M.D. | |
| University of Miami AIDS Clinical Research Unit | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Margaret A Fischl, MD 305-243-3838 mfischl@med.miami.edu | |
| Study Chair: | Margaret A Fischl, M.D. | University of Miami AIDS Clinical Research Unit |
More Information
| Responsible Party: | University of Miami AIDS Clinical Research Unit ( Margaret A. Fischl, M.D. ) |
| Study ID Numbers: | A009 |
| Study First Received: | April 2, 2008 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00654147 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
HIV antiretroviral therapy naive Integrase inhibitor HIV/AIDS treatment naïve |
|
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 Integrase Inhibitors 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 |
