Raltegravir Intensification in HIV-infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir; Placebo
Intervention description: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.; For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Treatment intensification; Low level viremia; Suboptimal CD4+ T cell response; treatment experienced

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.
    

Eligibility 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