Modulation of Monocyte Activation by Atorvastatin in HIV Infection
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|ClinicalTrials.gov Identifier: NCT01263938|
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Dementia||Drug: Atorvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Evaluate Effects of Atorvastatin on Monocyte Activation in HAART-treated HIV Infected Individuals|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.
For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day.
Other Name: Lipitor
- Effect of statins on peripheral blood monocytes [ Time Frame: Subjects enrolled in the study following the screening visit will be assessed for the primary outcome measures at T=0 (drug intervention begins); T=2wks; T=6wks; T=12wks (intervention ends); T=16wks (study ends) ]
Primary outcome measures include:
- Surface marker analyses of monocyte phenotype
- Plasma levels of soluble inflammatory mediators
- Effect of statins on T cell markers [ Time Frame: Subjects enrolled in the study following the screening visit will be assessed for the secondary outcome measures at T=0 (drug intervention begins); T=2wks; T=6wks; T=12wks (intervention ends); T=16wks (study ends) ]
Secondary outcome measures include:
- T cell surface markers
- expanded plasma cytokine profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263938
|United States, Pennsylvania|
|University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ronald G Collman, MD||University of Pennsylvania|