Status:
COMPLETED
Adding Maraviroc to Antiretroviral Therapy for Suboptimal CD4 T-Cell Recovery Despite Sustained Virologic Suppression
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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...
Detailed Description
The majority of HIV-infected subjects with virologic suppression on antiretroviral therapy (ART) have a marked increase in CD4+ T-cell counts over the first year on treatment. However, a portion of th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00709111
Start Date
January 1 2009
End Date
April 1 2010
Last Update
October 12 2018
Active Locations (29)
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1
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States, 35294
2
UCLA CARE Center CRS (601)
Los Angeles, California, United States, 90035
3
Stanford CRS (501)
Palo Alto, California, United States, 94304
4
Ucsd, Avrc Crs (701)
San Diego, California, United States, 92103