Raltegravir Intensification in HIV-infected Patients

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