RAL-eve Study: Raltegravir Substitution Study

Inclusion Criteria

• •1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry.
• •2. ART for at least 6 months prior to study entry with a regimen that includes enfuvirtide.
• •3. Self-defined infusion site reaction to enfuvirtide (usually will be painful inflammatory nodules)
• •4. No change in ART regimen for at least 3 months prior to study entry.
• •5. CD4+ cell count \>50/mm3 at screening (obtained within 60 days prior to study entry).
• •6. Documentation of HIV-1 RNA below the limit of quantification of an ultrasensitive assay
• •7. All HIV-1 RNA levels obtained within 6 months prior to study entry are below the limits of quantification on all tests, except as explained above in section 4.1.6 for a single detectable viral load of \<50 copies but \<200 copies in last 6 months.
• •8. Laboratory values obtained within 60 days prior to entry:
• •* Absolute neutrophil count (ANC) \>750/mm3
• •* Hemoglobin \>9.0 g/dL for female subjects and\>10.0 g/dL for male subjects
• •* Platelet count \>50,000/mm3
• •* Calculated creatinine clearance (CrCl) \>30 mL/min, as estimated by the Cockcroft-Gault equation\*
• •* AST (SGOT), ALT (SGPT), and alkaline phosphatase \<5 x ULN
• •* Total bilirubin \<2.5 x ULN. If the subject is taking an indinavir- or atazanavir-containing regimen at the time of screening, total bilirubin \<5 x ULN is acceptable.
• •9. For females of reproductive potential will need a negative serum or urine pregnancy test within 48 hours prior to entry.
• •10. Men and women age \>18 years.
• •11. Ability and willingness of subject to provide informed consent.