ABOUT THIS STUDY
1. 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.
2. Stable antiretroviral therapy for at least 12 months
3. Screening CD4+ T cell count below 350 cells/mm3
4. All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
5. Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA)
6. 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.
7. > 90% adherence to therapy within the preceding 30 days, as determined by self-report.
8. 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.
9. Ability and willingness of subject or legal guardian/representative to provide informed consent
1. Increase in CD4 count of > 100 cells/mm3 in past year.
2. Patients who are intending to modify antiretroviral therapy in the next 24 weeks for
3. Serious illness requiring hospitalization or parental antibiotics within preceding 3
4. Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory
drug in past 16 weeks.
5. HBVsAg+ or active hepatitis C or hepatitis B which will require treatment in the
subsequent 24 weeks.
6. Prior exposure to CCR5 inhibitors
7. Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000
cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.
8. Pregnant or breastfeeding women
9. Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.
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