At a glance
ClinicalIndex Comparison Record- ✓Documented HIV infection
- ✓CD4+ count documented within last 30 days (or at screening)
- ✓Currently on stable 3-drug HAART regimen with 2 NRTIs for >6 months
- ✓Viral load <50 copies/mm³ for >6 months, last result within 30 days (or at screening)
- ✕Prior therapy with Kaletra
- ✕Known hypersensitivity to Ritonavir
- ✕Use of contraindicated drugs with serious drug interactions (flecainide, propafenone, astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, lovastatin, simvastatin, midazolam, triazolam, St. John's wort)
- ✕Pregnancy or breast feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial of a Switch to a Kaletra + Current Dual Nucleoside Reverse Transcriptase Inhibitor (NRTI) Backbone Versus Continuation of the Current Regimen in Patients With Poor Immune Responses to Highly Active Antiretroviral Therapy (HAART) in Patients With Complete Viral Suppression: A Pilot Study
In Brief
A Phase 4 clinical trial evaluating Kaletra + Current Dual NRTI Backbone and Current Regimen for HIV Infections. Completed, enrolled 20 participants across 1 site.
Detailed 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.