Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
Badalona, Barcelona, Spain, 08916
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
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

No publications provided by Germans Trias i Pujol Hospital

Additional 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
Study First Received: August 25, 2009
Last Updated: January 23, 2013
Health Authority: Spain: Ministry of Health

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

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015