Status:
COMPLETED
Raltegravir Intensification in HIV-infected Patients
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00631449
Start Date
February 1 2008
End Date
March 1 2010
Last Update
August 17 2020
Active Locations (2)
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1
San Francisco General Hospital, Clinical Research Center
San Francisco, California, United States, 94110
2
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121