Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression

Inclusion Criteria

• HIV-1 infection
• On ART for at least 48 weeks prior to study entry with a regimen that includes three or more antiretroviral medications
• No change in ART regimen for at least 24 weeks prior to study entry
• Screening CD4+ T-cell count less than 250 obtained within 60 days prior to study entry
• Stable CD4+ T-cell count for at least 48 weeks prior to study entry (as assessed by an estimated CD4+ T-cell count slope between -20 and +20 cells/year)
• Screening HIV-1 RNA below the limit of detection using an FDA-approved assay obtained within 60 days prior to study entry
• All other plasma HIV-1 RNA measurements in the 48 weeks prior to study entry must be below the limit of detection
• Laboratory values obtained within 60 days prior to study entry:
• Absolute neutrophil count (ANC) >=750/µL
• Hemoglobin >=9.0 g/dL for female subjects and >=10.0 g/dL for male subjects
• Platelet count >=50,000/ µL
• Calculated creatinine clearance (CrCl) >=30 mL/min
• Aspartate aminotransferase (serum glutamic oxaloacetic transaminase), alanine aminotransferase (serum glutamic pyruvic transaminase), and alkaline phosphatase <=5 X Upper Limit of Normal (ULN)
• Direct bilirubin <=2.5 X ULN
• Females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to study entry
• Agree not to participate in the conception process, and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable forms of contraceptives while receiving study treatment and for 6 weeks after stopping study treatment.

Exclusion Criteria

• Unstable clinical condition
• Currently breast-feeding or pregnant
• Use of immunomodulators or cancer chemotherapy or radiation treatment within 12 months prior to study entry
• An acute AIDS-defining illness within 60 days prior to study entry
• Known allergy/sensitivity or hypersensitivity to components of MVC, including allergy or hypersensitivity to soya lecithin, soya or peanuts
• Active drug or alcohol abuse that, in the opinion of the investigator, would interfere with adherence to study regimens
• Serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry
• Receipt of a vaccine within 30 days prior to study entry
• Current or previous use of a CCR5 inhibitor
• Plan to change background ART regimen within 24 weeks after study entry
• Receipt of experimental or non-experimental medications for the purpose of raising CD4+ T-cell counts within 6 months prior to study entry