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NCT01600170 · ClinicalTrials.gov registry record · Phase 4
Downmodulating Monocyte Activation for HIV-1 Associated Neurocognitive Disorders (HAND)
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01600170: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01600170 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01600170, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
HIV associated neurological disorders (HAND), are a major problem even in ART treated people. HAND results from chronic inflammation which is largely attributed to expansion and activation of monocytes. These activated monocytes, some of which also carry virus to the brain, invade the CNS and release cytokines / chemokines resulting in further recruitment of monocytes, as well as release viral proteins which injure neurons and cause activation of other brain cells. Persistent monocyte/macrophage activation is thus a potential critical target for adjunctive therapy to treat or prevent HAND. The investigators therefore propose to study the effects of a statin drug (Atorvastatin), which has anti-inflammatory functions, on the monocyte activation status in ART treated HIV+ individuals. The investigators objectives are based on the hypothesis that Atorvastatin treatment will reduce the inflammatory and activated phenotype and function of monocytes which have been linked to HIV associated neuropathogenesis and occur in HIV infected subjects despite ART. In this study the investigators propose to 1\) define the effect of Atorvastatin on monocyte activation in HIV infected / ART treated subjects in a double blind, placebo controlled crossover study
Interventions
- DRUG placebo
- DRUG Atorvastatin (generic Lipitor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01600170
The ClinicalTrials.gov registry entry for NCT01600170 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01600170 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01600170 about?
NCT01600170 is a clinical study titled "Downmodulating Monocyte Activation for HIV-1 Associated Neurocognitive Disorders (HAND)". HIV associated neurological disorders (HAND), are a major problem even in ART treated people. HAND results from chronic inflammation which is largely attributed to expansion and activation of monocytes. These activated monocytes, some of which also carry virus to the brain, invade the CNS and releas...
What is the current status of trial NCT01600170?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2013-01. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01600170?
The interventions under investigation include: placebo (DRUG), Atorvastatin (generic Lipitor) (DRUG).
Who is sponsoring clinical trial NCT01600170?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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