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

This study has been completed.
Sponsor:
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

August 25, 2009
January 23, 2013
October 2009
May 2012   (final data collection date for primary outcome measure)
Viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00966329 on ClinicalTrials.gov Archive Site
  • Time to virological failure [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Administration of lipid-lowering drugs [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in the SCORE equation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • CD4 / CD8 cell counts [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Antiretroviral resistance and viral tropism [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Patients who withdraw [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Total cholesterol [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Total cholesterol levels
  • HDL-cholesterol [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    HDL-cholesterol levels
  • LDL-cholesterol [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    LDL-cholesterol levels
  • Triglyceride [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Triglyceride levels
  • Time to virological failure [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Administration of lipid-lowering drugs [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in the SCORE equation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • CD4 / CD8 cell counts [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Antiretroviral resistance and viral tropism [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Patients who withdraw [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Drug: maraviroc
    HAART regimen including 2 NRTI/NtRTIs plus maraviroc
  • 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).
  • Experimental: to switch from the NNRTI/PI to maraviroc
    to switch from the NNRTI/PI to maraviroc
    Intervention: Drug: maraviroc
  • Active Comparator: to continue with the same approach
    to continue with the same approach
    Intervention: Drug: control group
Bonjoch A, Pou C, Pérez-Álvarez N, Bellido R, Casadellà M, Puig J, Noguera-Julian M, Clotet B, Negredo E, Paredes R. Switching the third drug of antiretroviral therapy to maraviroc in aviraemic subjects: a pilot, prospective, randomized clinical trial. J Antimicrob Chemother. 2013 Jun;68(6):1382-7. doi: 10.1093/jac/dks539. Epub 2013 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00966329
MARAVI-SWITCH
No
Sílvia Gel, Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Eugènia Negredo, MD,PhD Lluita contra la Sida Foundation, HIV Unit
Germans Trias i Pujol Hospital
January 2013

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