Raltegravir Intensification in HIV-infected Patients
Completed · Phase 4 · Has a placebo group
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00631449
- Run by
- University of California, San Francisco
- People needed
- 30
- Starts
- 2008-02-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2020-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- San Francisco General Hospital, Clinical Research Center — San Francisco, California, United States
- San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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