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

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ClinicalTrials.gov Identifier: NCT00966329
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Sílvia Gel, Germans Trias i Pujol Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV HIV Infections Drug: maraviroc Drug: control group Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Viral load [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Time to virological failure [ Time Frame: 48 weeks ]
  2. Administration of lipid-lowering drugs [ Time Frame: 48 weeks ]
  3. Changes in the SCORE equation [ Time Frame: 48 weeks ]
  4. CD4 / CD8 cell counts [ Time Frame: 48 weeks ]
  5. Antiretroviral resistance and viral tropism [ Time Frame: 48 weeks ]
  6. Patients who withdraw [ Time Frame: 48 weeks ]
  7. Total cholesterol [ Time Frame: 48 weeks ]
    Total cholesterol levels

  8. HDL-cholesterol [ Time Frame: 48 weeks ]
    HDL-cholesterol levels

  9. LDL-cholesterol [ Time Frame: 48 weeks ]
    LDL-cholesterol levels

  10. Triglyceride [ Time Frame: 48 weeks ]
    Triglyceride levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  1. Virologic failure to a previous antiretroviral regimen.
  2. Any antiretroviral resistance mutation in a previous resistance test.
  3. 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.
  4. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
  5. Pregnancy or fertile women willing to be pregnant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Sílvia Gel, Germans Trias i Pujol Hospital:
Switching
Maraviroc
Virological efficacy
Lipid profile
Tropism

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Maraviroc
 Protease Inhibitors
Reverse Transcriptase Inhibitors
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors