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

This study has been completed.
Information provided by (Responsible Party):
Margaret A. Fischl, M.D., University of Miami
ClinicalTrials.gov Identifier:
First received: April 2, 2008
Last updated: June 2, 2014
Last verified: June 2014

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.

Condition Intervention Phase
HIV Infections
Drug: Raltegravir and Lopinavir/ritonavir
Drug: Raltegravir, emtricitabine, tenofovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • time to confirmed virologic failure (plasma HIV-1 RNA levels ≥1000 copies/ml [ Time Frame: week 16, week 24, ≥200 copies/ml after week 24) ] [ Designated as safety issue: No ]
  • study medication toxicity-related discontinuation of any component of the initial randomized study regimen. [ Time Frame: anytime during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to compare virologic responses (confirmed plasma HIV-1 RNA <200 copies/ml and <50 copies/ml) in the two treatment arms. [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
  • evaluate immunologic response defined as increases in CD4+ and CD8+ cell counts in the two treatment arms [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
  • determine the safety and tolerability (proportion of subjects receiving study treatment) in the two treatment arms [ Time Frame: weeks 4, 8, 16, 24, 32, 40 and 48 ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir & Lopinavir/ritonavir
Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
Drug: Raltegravir and Lopinavir/ritonavir
400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
Other Names:
  • Isentress
  • Kaletra
Active Comparator: Raltegravir & emtricitabine/tenofovir
Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
Drug: Raltegravir, emtricitabine, tenofovir
400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48
Other Names:
  • Isentress
  • Truvada

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00654147

United States, Florida
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136
Sponsors and Collaborators
Margaret A. Fischl, M.D.
Study Chair: Margaret A Fischl, M.D. University of Miami AIDS Clinical Research Unit
  More Information

No publications provided

Responsible Party: Margaret A. Fischl, M.D., Professor of Medicine, Director AIDS Clinical Research Unit, University of Miami
ClinicalTrials.gov Identifier: NCT00654147     History of Changes
Other Study ID Numbers: A009
Study First Received: April 2, 2008
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
antiretroviral therapy naive
Integrase inhibitor
treatment naïve

Additional relevant MeSH terms:
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015