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NCT01263938 · ClinicalTrials.gov registry record · Phase 4
Modulation of Monocyte Activation by Atorvastatin in HIV Infection
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT01263938: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01263938 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01263938, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Activated monocytes play a key role in the pathogenesis of HIV-associated neurocognitive disorders (HAND). Individuals with HAND have expanded populations of activated monocytes. These monocytes are thought to emigrate into the CNS, where they produce neurotoxic proinflammatory factors, and also carry virus into the CNS. Statins are cholesterol lowering drugs with pleiotropic immunomodulatory / anti-inflammatory properties that are currently being explored for immunomodulation of T cell activation in several diseases, in addition to their established role to treat hyperlipidemia and atherosclerosis. The investigators in vitro data suggests that these drugs can downregulate monocyte activation patterns seen in HIV infection. No in vivo studies have yet been carried out to assess the effects of statins on the pro-inflammatory monocyte population in chronic HIV disease. This will be a pilot study of whether statin treatment will reduce the inflammatory monocyte phenotype and downregulate the inflammatory cytokines that have been linked to neuropathogenesis in HIV infection. If so, they may have potential as adjunctive therapy in HIV-associated neurological disease. The investigators propose to: * Determine the effect of Atorvastatin on peripheral blood monocyte populations in a 12-week pilot study in chronically HIV-infected people on HAART therapy. * Determine the relationship between changes in monocyte phenotype following Atorvastatin treatment, and soluble markers of activation/inflammation linked to neuropathogenesis, as well as activation status of T cells.
Primary Outcome
Effects of Atorvastatin on immune activation associated surface markers (CD16, CD163 and CCR2) of monocytes were assessed in chronic HIV+/HAART+ subjects following 12 weeks of treatment. Whole blood drawn from these subjects were stained with fluorochrome tagged antibodies to the surface markers. Stained whole blood cells were then acquired on a flow cytometer and analyzed using the Flowjo software to determine the percentage of cells (monocytes) expressing the specific marker. This was done bef
Interventions
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
What the finished NCT01263938 record still lists
NCT01263938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin is the first listed.
NCT01263938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01263938 about?
NCT01263938 is a clinical study titled "Modulation of Monocyte Activation by Atorvastatin in HIV Infection". Activated monocytes play a key role in the pathogenesis of HIV-associated neurocognitive disorders (HAND). Individuals with HAND have expanded populations of activated monocytes. These monocytes are thought to emigrate into the CNS, where they produce neurotoxic proinflammatory factors, and also car...
What is the current status of trial NCT01263938?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2011-09. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01263938?
The interventions under investigation include: Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01263938?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01263938's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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