Expired Study
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Miami, Florida 33136


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. 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 RAL in the two treatment arms and their relationship with functional CD8 T cells and if RAL containing therapies lead to a decrease in markers of gut microbial translocation and of cellular and soluble markers of immune activation.


Study summary:

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.


Criteria:

Inclusion Criteria: - Documented HIV Infection - Genotypic resistance without major resistance mutations within 30 days - Antiretroviral drug-naïve - Screening HIV-1 RNA ≥5000 - Women of reproductive potential - Negative pregnancy test within 48 hours Exclusion Criteria: - Acute or recent HIV-1 infection - Currently breast feeding - Use of immunomodulators - Evidence of major resistance mutations - HBsAg positive - Acute hepatitis of any etiology or clinically significant liver disease - Current imprisonment or involuntary incarceration


NCT ID:

NCT00654147


Primary Contact:

Study Chair
Margaret A Fischl, M.D.
University of Miami AIDS Clinical Research Unit


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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