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NCT00870363 · ClinicalTrials.gov registry record · Phase 4
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy
A Phase 4 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT00870363: Completed Phase 4 study, sponsored by University of California, Davis.
NCT00870363 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00870363, a Phase 4 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
This research study is being done to find out how the immune system in the small intestines improves after taking antiretroviral (anti-HIV) medications. Biopsies (small snips of tissue) will be taken from the part of the intestines just below the stomach, and will be studied in the laboratory. The main purpose of this study is to measure the increase in the numbers of immune cells in the intestines to see if this number is related to the amount of medication that reaches the intestinal tissue, and the amount of virus that is still hiding there. Subjects are either normal control subjects without HIV or, are HIV positive and are about to start HIV medications. As part of this study, HIV positive patients will be randomized to receive one of three possible combinations of medications. 1. maraviroc (Selzentry) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) or 2. maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) or 3. efavirenz (Sustiva) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) Both Maraviroc and Raltegravir each represent new classes of medications in the way that they interfere with HIV making copies of itself. Maraviroc attaches to the surface of the T-cell that the virus uses to get into the cell and is therefore known as an entry inhibitor. Raltegravir blocks the virus from inserting itself into the DNA of the infected cell's nucleus and is therefore known as an Integrase Inhibitor. We hope to learn more about how antiretroviral drugs affect T cells and how immune function restores itself when HIV infection is treated.
Primary Outcome
immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria
Interventions
- DRUG maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)
- DRUG maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor)
- DRUG efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT00870363 record still lists
NCT00870363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) is the first listed.
NCT00870363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00870363 about?
NCT00870363 is a clinical study titled "A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy". This research study is being done to find out how the immune system in the small intestines improves after taking antiretroviral (anti-HIV) medications. Biopsies (small snips of tissue) will be taken from the part of the intestines just below the stomach, and will be studied in the laboratory. The m...
What is the current status of trial NCT00870363?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2009-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00870363?
The interventions under investigation include: maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) (DRUG), maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) (DRUG), efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)] (DRUG).
Who is sponsoring clinical trial NCT00870363?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00870363's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 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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