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

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.

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.