Clinical Trials


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

This study has been completed
Margaret A. Fischl, M.D.

Information provided by (Responsible Party)
Margaret A. Fischl, M.D., University of Miami Identifier

First received: April 2, 2008
Last updated: July 11, 2015
Last Verified: July 2015
History of Changes


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 Intervention Phase
HIV Infections

Drug : Raltegravir & Lopinavir/ritonavir
Drug : Raltegravir and emtricitabine/tenofovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Margaret A. Fischl, M.D., University of Miami:

Primary Outcome Measures

  • 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)
Secondary Outcome Measures:
  • 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

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
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

Other Name:
  • Isentress
  • Kaletra

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

Other Name:
  • 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  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its 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

More Information

Responsible Party: Margaret A. Fischl, M.D., Professor of Medicine, Director AIDS Clinical Research Unit, University of Miami Identifier: NCT00654147   History of Changes  
Other Study ID Numbers: A009  
Study First Received: April 2, 2008  
Last Updated: July 11, 2015  

Keywords provided by Margaret A. Fischl, M.D., University of Miami:

antiretroviral therapy naive
Integrase inhibitor
treatment naïve

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium processed this data on May 29, 2020
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