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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). 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
Primary Outcome
Whole blood drawn from participants 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 change in percentage of monocytes expressing the specific marker (CD16) at 12 wk versus 0wk within each Period. Data is shown as fold change over 12 weeks, in percent positive monocytes expressing surface markers. Change in primary outcome measures in each treatment a
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 |
What the finished NCT01600170 record still lists
NCT01600170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01600170 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01600170's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 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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