Raltegravir Intensification in HIV-infected Patients

Phase 4

Completed

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 to antiretroviral therapy.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Raltegravir	Raltegravir	For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.	Week 12

Secondary Outcome Measures

Name	Time	Method
Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24	Baseline and Week 24

Locations (2): San Francisco General Hospital, Clinical Research Center
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San Francisco, California, United States
San Francisco Veterans Affairs Medical Center
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San Francisco, California, United States