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NCT00775606 · ClinicalTrials.gov registry record · Phase 4
Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease
A Phase 4 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00775606 is a Phase 4 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 15 participants.
The verdict
NCT00775606, a Phase 4 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regimens that do not contain protease inhibitors. This is a study that will determine the difference in immune enhancement capabilities between an anti-HIV regimen that contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz. Both medications are recommended as first line treatments for HIV-infected patients. This study will recruit HIV-positive patients that need to start anti-HIV treatment because their CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine the difference in immune reconstitution over 24 weeks of treatment with study medications. Among the immune parameters that will be measured is the ability of each subject to respond to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine. Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend to have a lower response rate to these vaccines.
Interventions
- DRUG Efavirenz
- DRUG Lopinavir 400 mg/ritonavir 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00775606
The ClinicalTrials.gov registry entry for NCT00775606 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Efavirenz is the first listed.
NCT00775606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00775606 about?
NCT00775606 is a clinical study titled "Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease". The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function better than regimens that do not contain protease inhibitors. This is a study that will determine the difference in ...
What is the current status of trial NCT00775606?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2008-10. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00775606?
The interventions under investigation include: Efavirenz (DRUG), Lopinavir 400 mg/ritonavir 100 mg (DRUG).
Who is sponsoring clinical trial NCT00775606?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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