Overview
Raltegravir Intensification in HIV-infected Patients
Status:
Completed
Completed
Trial end date:
2010-03-01
2010-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of California, San FranciscoCollaborator:
Merck Sharp & Dohme Corp.Treatments:
Raltegravir Potassium
Criteria
Inclusion Criteria:- Stable antiretroviral therapy for at least 12 months
- Screening CD4+ T cell count < 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 or < 40 copies/mL using Abbott
RT-PCR), and all available determinations in past 12 months also below level of
detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they
were preceded and followed by undetectable viral load determinations).
- >90% adherence to therapy within the preceding 30 days, as determined by self-report
- Both male and female adult (at least 18 years old) 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.
Exclusion Criteria:
- 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
- **Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study
period
- Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory
drug in past 16 weeks
- Concurrent treatment with phenobarbital, phenytoin, or rifampin.
- Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000
cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute
- Pregnant or breastfeeding women