A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Kaletra + Current Dual NRTI Backbone; Current Regimen
Intervention MeSH terms: Ritonavir; Lopinavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HIV; HAART (Highly Active Anti-Retroviral Therapy) partial immune response; no immune response; Treatment Experienced

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.
    

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