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NCT00145795 · ClinicalTrials.gov registry record · Phase 4
A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
A Phase 4 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00145795 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 20 participants.
The verdict
NCT00145795, a Phase 4 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG Kaletra + Current Dual NRTI Backbone
- DRUG Current Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00145795
The ClinicalTrials.gov registry entry for NCT00145795 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Kaletra + Current Dual NRTI Backbone is the first listed.
NCT00145795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00145795 about?
NCT00145795 is a clinical study titled "A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment". 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...
What is the current status of trial NCT00145795?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2004-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00145795?
The interventions under investigation include: Kaletra + Current Dual NRTI Backbone (DRUG), Current Regimen (DRUG).
Who is sponsoring clinical trial NCT00145795?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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