Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Margaret A. Fischl, M.D.
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Integrase Inhibitors; Lopinavir; Raltegravir Potassium; Ritonavir; Tenofovir

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