Back to resultsSwitching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
Primary Purpose
HIV, HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
maraviroc
control group
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism
Eligibility Criteria
Inclusion Criteria:
- HIV-1 infected adults (=/+18 years old).
- 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.
- Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
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.
- Nadir CD4 cell count > 350 cells/mm3.
- Absence of resistance mutations in the RT or PR by (TrugeneTM)
- Good treatment adherence.
- 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.
Sites / Locations
- Germans Trias i Pujol Hospital
- Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
- Lluita contra la Sida Foundation, HIV Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
to switch from the NNRTI/PI to maraviroc
to continue with the same approach
Arm Description
to switch from the NNRTI/PI to maraviroc
to continue with the same approach
Outcomes
Primary Outcome Measures
Viral load
Secondary Outcome Measures
Time to virological failure
Administration of lipid-lowering drugs
Changes in the SCORE equation
CD4 / CD8 cell counts
Antiretroviral resistance and viral tropism
Patients who withdraw
Total cholesterol
Total cholesterol levels
HDL-cholesterol
HDL-cholesterol levels
LDL-cholesterol
LDL-cholesterol levels
Triglyceride
Triglyceride levels
Full Information
NCT ID
NCT00966329
First Posted
August 25, 2009
Last Updated
January 23, 2013
Sponsor
Germans Trias i Pujol Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00966329
Brief Title
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Germans Trias i Pujol Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
to switch from the NNRTI/PI to maraviroc
Arm Type
Experimental
Arm Description
to switch from the NNRTI/PI to maraviroc
Arm Title
to continue with the same approach
Arm Type
Active Comparator
Arm Description
to continue with the same approach
Intervention Type
Drug
Intervention Name(s)
maraviroc
Intervention Description
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
Intervention Type
Drug
Intervention Name(s)
control group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Viral load
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Time to virological failure
Time Frame
48 weeks
Title
Administration of lipid-lowering drugs
Time Frame
48 weeks
Title
Changes in the SCORE equation
Time Frame
48 weeks
Title
CD4 / CD8 cell counts
Time Frame
48 weeks
Title
Antiretroviral resistance and viral tropism
Time Frame
48 weeks
Title
Patients who withdraw
Time Frame
48 weeks
Title
Total cholesterol
Description
Total cholesterol levels
Time Frame
48 weeks
Title
HDL-cholesterol
Description
HDL-cholesterol levels
Time Frame
48 weeks
Title
LDL-cholesterol
Description
LDL-cholesterol levels
Time Frame
48 weeks
Title
Triglyceride
Description
Triglyceride levels
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 infected adults (=/+18 years old).
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.
Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
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.
Nadir CD4 cell count > 350 cells/mm3.
Absence of resistance mutations in the RT or PR by (TrugeneTM)
Good treatment adherence.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugènia Negredo, MD,PhD
Organizational Affiliation
Lluita contra la Sida Foundation, HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Lluita contra la Sida Foundation, HIV Unit
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23354282
Citation
Bonjoch A, Pou C, Perez-Alvarez N, Bellido R, Casadella 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.
Results Reference
derived
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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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