Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects (HIV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00654147|
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : July 13, 2015
Last Update Posted : August 3, 2015
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir & Lopinavir/ritonavir Drug: Raltegravir and emtricitabine/tenofovir||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: Raltegravir & Lopinavir/ritonavir
Raltegravir 400 mg tablet and Lopinavir/ritonavir capsule by mouth, every 12 hours for 48 weeks
Drug: Raltegravir & Lopinavir/ritonavir
Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor
Active Comparator: Raltegravir & emtricitabine/tenofovir
Raltegravir 400 mg tablet bu mouth, every 12 hours for 48 weeks and tenofovir/embritcitabine 200 mg/100 mg table by mouth, once daily for 48 weeks
Drug: Raltegravir and emtricitabine/tenofovir
Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors
- Time to Confirmed Virologic Failure [ Time Frame: weeks ]time to confirmed viologic failure at 24 weeks (up to 48 weeks)
- Time to Virologic Failure [ Time Frame: week 24 (up to 48 weeks) ]time to virologic failure at week 24 (up to 48 weeks)
- Study Medication Toxicity-related Discontinuation . [ Time Frame: 48 weeks ]grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity
- Weeks to HIV-1 RNA <200 Copies/ml [ Time Frame: from date of treatment start to first week documented viral suppression ]time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml
- Change From Baseline CD4+ and CD8+ Cell Counts [ Time Frame: Baseline, Weeks 16 and 24 ]mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms
- Study Medication Tolerability [ Time Frame: date started study treatment to first week documented change study treatment up to week 48 ]study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654147
|United States, Florida|
|University of Miami AIDS Clinical Research Unit|
|Miami, Florida, United States, 33136|
|Study Chair:||Margaret A Fischl, M.D.||University of Miami AIDS Clinical Research Unit|