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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00654147

Run by

Margaret A. Fischl, M.D.

People needed

44

Starts

2008-04-01

Expected to finish

2012-01-01

Last updated by the study team

2015-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami AIDS Clinical Research Unit — Miami, Florida, United States

Full record on ClinicalTrials.gov

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