Phase 4
Completed N=20
A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
Source: ClinicalTrials.gov NCT00145795 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Immune Reconstitution [3 Months] — 41.56; 49.40 cells per cubic millimeter — p=0.81
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Reconstitution [3 Months] |
41.56; 49.40 | 0.81 |
| PRIMARY Immune Reconstitution [6 Months] |
116; 32 | 0.03 sig |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months] |
15.27; 24.53 | 0.08 |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months] |
16.60; 22.53 | 0.29 |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months] |
14.10; 17.94 | 0.29 |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months] |
10.03; 18.92 | 0.04 sig |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months] |
20.92; 16.74 | 0.21 |
| SECONDARY Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months] |
17.07; 19.01 | 0.61 |
| SECONDARY Clinical HIV-related Events |
0; 0 | — |
| SECONDARY Rates of Virologic Failure |
0; 0 | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT00145795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.