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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: Completed Phase 4 study, sponsored by University of Chicago.
NCT00145795 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 3 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortalit
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 |
What the finished NCT00145795 record still lists
NCT00145795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Kaletra + Current Dual NRTI Backbone is the first listed.
NCT00145795 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00145795's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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