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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Margaret A. Fischl, M.D., University of Miami
ClinicalTrials.gov Identifier:
NCT00654147
First received: April 2, 2008
Last updated: June 2, 2014
Last verified: June 2014

April 2, 2008
June 2, 2014
April 2008
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • time to confirmed virologic failure (plasma HIV-1 RNA levels ≥1000 copies/ml [ Time Frame: at or after week 16 and before week 24, or ≥200 copies/ml at or 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 ]
Complete list of historical versions of study NCT00654147 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Raltegravir and Lopinavir/ritonavir
    400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks
    Other Names:
    • Isentress
    • Kaletra
  • 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
  • Experimental: Raltegravir & Lopinavir/ritonavir
    Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks
    Intervention: Drug: Raltegravir and Lopinavir/ritonavir
  • Active Comparator: Raltegravir & emtricitabine/tenofovir
    Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks
    Intervention: Drug: Raltegravir, emtricitabine, tenofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00654147
A009
Yes
Margaret A. Fischl, M.D., University of Miami
Margaret A. Fischl, M.D.
Not Provided
Study Chair: Margaret A Fischl, M.D. University of Miami AIDS Clinical Research Unit
University of Miami
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP