A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders. We also are interested in knowing if this agent improves immune response by affecting cluster of differentiation 4 (CD4) + T cell death (apoptosis) or by further inhibiting (preventing) ongoing, low-level, viral replication to levels below detection by current viral load measurements. This will help us understand why immune responses to effective antiretroviral therapy are so different and help determine some possible guidelines for managing patients with poor immune responses.

Hypothesis: Patients with poor immune responses to HAART who receive Kaletra in place of their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) while continuing their current 2 NRTI backbone will have improved immune response to therapy compared to patients who continue their current regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Abbott
• Treatments: Lopinavir; Reverse Transcriptase Inhibitors; Ritonavir

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