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Clinical Trials

MainTitle

Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

This study has been completed
Sponsor
Germans Trias i Pujol Hospital


Information provided by (Responsible Party)
Sílvia Gel, Germans Trias i Pujol Hospital

ClinicalTrials.gov Identifier
NCT00966329

First received: August 25, 2009
Last updated: January 23, 2013
Last Verified: January 2013
History of Changes
Purpose

Purpose

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

Condition Intervention Phase
HIV
HIV Infections

Drug : maraviroc
Drug : control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression

Further study details as provided by Sílvia Gel, Germans Trias i Pujol Hospital:

Primary Outcome Measures

  • Viral load [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Time to virological failure [ Time Frame: 48 weeks ]
  • Administration of lipid-lowering drugs [ Time Frame: 48 weeks ]
  • Changes in the SCORE equation [ Time Frame: 48 weeks ]
  • CD4 / CD8 cell counts [ Time Frame: 48 weeks ]
  • Antiretroviral resistance and viral tropism [ Time Frame: 48 weeks ]
  • Patients who withdraw [ Time Frame: 48 weeks ]
  • Total cholesterol [ Time Frame: 48 weeks ]
    Total cholesterol levels
  • HDL-cholesterol [ Time Frame: 48 weeks ]
    HDL-cholesterol levels
  • LDL-cholesterol [ Time Frame: 48 weeks ]
    LDL-cholesterol levels
  • Triglyceride [ Time Frame: 48 weeks ]
    Triglyceride levels

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: to switch from the NNRTI/PI to maraviroc
to switch from the NNRTI/PI to maraviroc
Drug: maraviroc

HAART regimen including 2 NRTI/NtRTIs plus maraviroc

Active Comparator: to continue with the same approach
to continue with the same approach
Drug: control group
    HAART regimen including 2 NRTI/NtRTIs plus one of the following :
    • 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir)
    • or ATV/unboosted (in a regimen without tenofovir)
    • or 1 NNRTI (nevirapine or efavirenz).

    Detailed Description:

    This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
    Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).
    Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
    The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    1. HIV-1 infected adults (=/+18 years old).
    2. Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
    3. Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
    4. Patient having at least one of the following conditions:
      • Antiretroviral-related gastrointestinal disturbances, or
      • Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or
      • Any toxicity drug related.
    5. Nadir CD4 cell count > 350 cells/mm3.
    6. Absence of resistance mutations in the RT or PR by (TrugeneTM)
    7. Good treatment adherence.
    8. Voluntary written informed consent.

  • Exclusion Criteria:
  • Virologic failure to a previous antiretroviral regimen.
  • Any antiretroviral resistance mutation in a previous resistance test.
  • Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
  • Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
  • Pregnancy or fertile women willing to be pregnant.

    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 ClinicalTrials.gov identifier: NCT00966329

    Locations

    Spain
    Germans Trias i Pujol Hospital
    Badalona, Barcelona, Spain, 08916
    Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
    Badalona, Barcelona, Spain, 08916
    Lluita contra la Sida Foundation, HIV Unit
    Badalona, Barcelona, Spain, 08916

    Sponsors and Collaborators

    Germans Trias i Pujol Hospital

    Investigators

    Principal Investigator: Eugènia Negredo, MD,PhD Lluita contra la Sida Foundation, HIV Unit
    More Information

    More Information


    Responsible Party: Sílvia Gel, Dra. Eugenia Negredo, Germans Trias i Pujol Hospital  
    ClinicalTrials.gov Identifier: NCT00966329   History of Changes  
    Other Study ID Numbers: MARAVI-SWITCH  
    Study First Received: August 25, 2009  
    Last Updated: January 23, 2013  

    Keywords provided by Sílvia Gel, Germans Trias i Pujol Hospital:

    Switching
    Maraviroc
    Virological efficacy
    Lipid profile
    Tropism

    Additional relevant MeSH terms:
    HIV Infections
    Maraviroc
    Protease Inhibitors
    Reverse Transcriptase Inhibitors

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.