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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV, HIV Infections

Intervention / Treatment
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* Drug: maraviroc
* Drug: control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: to switch from the NNRTI/PI to maraviroc<br>to switch from the NNRTI/PI to maraviroc | Drug: maraviroc<br>* HAART regimen including 2 NRTI/NtRTIs plus maraviroc<br>|
| Active Comparator: to continue with the same approach<br>to continue with the same approach | Drug: control group<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load |  | 48 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Switching, Maraviroc, Virological efficacy, Lipid profile, Tropism