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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite viral suppression, antiretroviral therapy (ART) does not restore CD4+ T-cell counts in some subjects. The purpose of this study is to assess whether adding maraviroc (MVC) to a suppressive ART will result in a significant CD4+ T-cell count increase over 24 weeks in subjects with suboptimal CD4+ T-cell recovery despite sustained virologic suppression.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Maraviroc

Criteria

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