CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Atorvastatin (generic Lipitor) +1 moredrug
Likely dose
Atorvastatin (generic Lipitor) 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01600170
NCT01600170Phase 4Completed

Statin Modulation of Monocyte/Macrophage Activation for HAND Treatment

University of Pennsylvania·interventional·Posted May 16, 2012·Updated Nov 23, 2020

In Brief

A Phase 4 clinical trial evaluating Atorvastatin (generic Lipitor) and placebo for HIV Dementia. Completed, enrolled 11 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Dementia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2012
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.1 years ago

Interventions

Atorvastatin (generic Lipitor)drug

Atorvastatin is an FDA approved prescription drug which is frequently used to lower cholesterol levels.It is available in the form of tablets ranging in dose from 10-80mg.

placebodrug

A substance containing no medication and prescribed or given to reinforce a patient's expectation to get well.