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

January 23, 2013 updated by: Sílvia Gel, Germans Trias i Pujol Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral load
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARAVI-SWITCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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