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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
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).
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Barcelona, Spain
Lluita contra la Sida Foundation, HIV Unit
Badalona, Barcelona, Spain
Viral load
Time frame: 48 weeks
Time to virological failure
Time frame: 48 weeks
Administration of lipid-lowering drugs
Time frame: 48 weeks
Changes in the SCORE equation
Time frame: 48 weeks
CD4 / CD8 cell counts
Time frame: 48 weeks
Antiretroviral resistance and viral tropism
Time frame: 48 weeks
Patients who withdraw
Time frame: 48 weeks
Total cholesterol
Total cholesterol levels
Time frame: 48 weeks
HDL-cholesterol
HDL-cholesterol levels
Time frame: 48 weeks
LDL-cholesterol
LDL-cholesterol levels
Time frame: 48 weeks
Triglyceride
Triglyceride levels
Time frame: 48 weeks
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