Status:
COMPLETED
Maraviroc as an Immunomodulatory Drug for Antiretroviral-treated HIV Infected Patients Exhibiting Immunologic Failure
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Pfizer
amfAR, The Foundation for AIDS Research
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Many people with HIV fail to regain normal CD4 counts despite effectively suppressing HIV replication with medications. Blocking the "co-receptor" for HIV might decrease inflammation of the immune sys...
Detailed Description
Our primary hypothesis is that CCR5 inhibitors may have protective immunomodulatory effects independent of their impact on HIV replication. Specifically, we predict that maraviroc will reduce the pers...
Eligibility Criteria
Inclusion
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Stable antiretroviral therapy for at least 12 months
- Screening CD4+ T cell count below 350 cells/mm3
- All available CD4+ T cell counts in the last year and at screening \< 350 cells/mm3
- Screening plasma HIV RNA levels below level of detection (\< 50 copies RNA/mL using Roche Amplicor or \< 75 copies/mL using Bayer bDNA)
- All available plasma HIV RNA levels within past year below the level of detection. Isolated values that are detectable but \< 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable.
- \> 90% adherence to therapy within the preceding 30 days, as determined by self-report.
- Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Ability and willingness of subject or legal guardian/representative to provide informed consent
Exclusion
- Increase in CD4 count of \> 100 cells/mm3 in past year.
- Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason.
- Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
- Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks.
- HBVsAg+ or active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks.
- Prior exposure to CCR5 inhibitors
- Screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<50,000 cells/mm3, hemoglobin \< 8mg/dL, estimated creatinine clearance \<40 mL/minute.
- Pregnant or breastfeeding women
- Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00735072
Start Date
September 1 2008
End Date
July 1 2010
Last Update
August 17 2020
Active Locations (4)
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1
University of California San Francisco - San Francisco General Hospital
San Francisco, California, United States, 94110
2
Stanford University
Stanford, California, United States, 94305
3
Rush University - Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
4
Case Western Reserve University
Cleveland, Ohio, United States, 44106