Trial record 15 of 38 for:    " December 15, 2010":" January 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Modulation of Monocyte Activation by Atorvastatin in HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01263938
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 12, 2017
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Pennsylvania

December 17, 2010
December 21, 2010
December 12, 2017
September 2011
October 2017   (Final data collection date for primary outcome measure)
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:
  1. Surface marker analyses of monocyte phenotype
  2. Plasma levels of soluble inflammatory mediators
Same as current
Complete list of historical versions of study NCT01263938 on Archive Site
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:
  1. T cell surface markers
  2. expanded plasma cytokine profile
Same as current
Not Provided
Not Provided
Modulation of Monocyte Activation by Atorvastatin in HIV Infection
Pilot Study to Evaluate Effects of Atorvastatin on Monocyte Activation in HAART-treated HIV Infected Individuals

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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Dementia
Drug: Atorvastatin

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
Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2017
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Chronic HIV-1 infected individuals presently on HAART with no change in drug combination for at least 3 months at time of enrollment
  2. Plasma viral load <200 copies / ml for at least 6 months prior to enrollment in the study
  3. CD4 T cell count more than 350/ul
  4. Willingness to use a method of contraception during the study period
  5. Willingness to have blood drawn
  6. If female, willingness to undergo pregnancy testing on a monthly basis and are not breastfeeding
  7. Ability to understand and willingness to sign the informed consent
  8. hs-CRP levels above the upper limit of normal (>3mg/L)

Exclusion Criteria:

  1. Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe
  2. Use of any anti-inflammatory drugs (OTC or prescription) on a daily basis
  3. Pregnancy or breast feeding
  4. Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study
  5. Allergy or hypersensitivity to statins or any of its components
  6. History of myositis or rhabdomyolysis with use of any statins
  7. Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids will be ineligible for 3 months after completion of therapy with the immunomodulating agents
  8. History of inflammatory muscle disease such as poly or dermatomyositis
  9. Serious intercurrent illness requiring systemic treatment and/or hospitalization within 30 days of entry
  10. Evidence of active opportunistic infections requiring treatment or neoplasms that require chemotherapy during the study period
  11. Creatine phosphokinase elevations (CPK) greater than 3 times the upper limit of normal
  12. Known active liver disease or AST/ALT greater than 2x the upper limit of normal
  13. Renal insufficiency, indicated by serum creatinine 2 mg/dl
  14. Absolute neutrophil count (ANC) 1000/mm3, hemoglobin < 10.0 g/dL for males and <9 g/dL for females, platelet count 100,000/mm
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
IRB Protocol #: 812196
P30AI045008 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Ronald G Collman, MD University of Pennsylvania
University of Pennsylvania
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP