A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, HAART (Highly Active Anti-Retroviral Therapy) partial immune response, no immune response, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: HIV Infection documented CD4+ count within the last 30 days (or drawn with screening labs) Currently on a stable 3-drug HAART regimen including 2 NRTIs for > 6 month viral load (VL) < 50/mm3 for > 6 months, last within the last 30 days (or drawn with screening labs) Partial immune responder or immune non-responder Age > 18 years Labs (drawn at screening) Alanine transaminase (ALT) < 5 X the upper limit of normal (ULN) Total bili < 2 X ULN Creatinine < 2.0 mg/dL Exclusion Criteria: Prior therapy with Kaletra Known hypersensitivity to Ritonavir Therapy the drugs with potential serious drug interactions: flecainide, propafenone, astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, lovastatin, simvastatin, midazolam, triazolam, and St. John's wart. Pregnancy; breast feeding Current malignancy requiring CT Use of systemic corticosteroids, immunosuppressive, or cytotoxic agents within the last 45 days Fever and/or evidence of an active infectious complication Currently in another interventional clinical trial Receiving Interleukin-2 (IL-2) or any other cytokine or growth factor Enrollment in another interventional clinical trial
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Kaletra + Current Dual NRTI Backbone
Current Regimen
Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
Patients in this study arm continued their current regimen.