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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00709111

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

34

Starts

2009-01-01

Expected to finish

2010-04-01

Last updated by the study team

2018-10-12

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alabama Therapeutics CRS (5801) — Birmingham, Alabama, United States
• UCLA CARE Center CRS (601) — Los Angeles, California, United States
• Stanford CRS (501) — Palo Alto, California, United States
• Ucsd, Avrc Crs (701) — San Diego, California, United States
• Ucsf Aids Crs (801) — San Francisco, California, United States
• Georgetown University CRS (GU CRS) (1008) — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS (901) — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS (5802) — Atlanta, Georgia, United States
• Northwestern University CRS (2701) — Chicago, Illinois, United States
• IHV Baltimore Treatment CRS (4651) — Baltimore, Maryland, United States
• Johns Hopkins Adult AIDS CRS (201) — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS (101) — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States
• Boston Medical Center ACTG CRS (104) — Boston, Massachusetts, United States
• Washington University CRS (2101) — St Louis, Missouri, United States
• Cornell CRS (7804) — New York, New York, United States
• NY Univ. HIV/AIDS CRS (401) — New York, New York, United States
• AIDS Care CRS (1108) — Rochester, New York, United States
• Univ. of Rochester ACTG CRS (1101) — Rochester, New York, United States
• Unc Aids Crs (3201) — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS (1601) — Durham, North Carolina, United States
• Univ. of Cincinnati CRS (2401) — Cincinnati, Ohio, United States
• MetroHealth CRS (2503) — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS (2301) — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS (6201) — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.