Status:
COMPLETED
Modulation of Monocyte Activation by Atorvastatin in HIV Infection
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Dementia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Chronic HIV-1 infected individuals presently on HAART with no change in drug combination for at least 3 months at time of enrollment
- Plasma viral load \<200 copies / ml for at least 6 months prior to enrollment in the study
- CD4 T cell count more than 350/ul
- Willingness to use a method of contraception during the study period
- Willingness to have blood drawn
- If female, willingness to undergo pregnancy testing on a monthly basis and are not breastfeeding
- Ability to understand and willingness to sign the informed consent
- hs-CRP levels above the upper limit of normal (\>3mg/L)
Exclusion
- Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe
- Use of any anti-inflammatory drugs (OTC or prescription) on a daily basis
- Pregnancy or breast feeding
- 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
- Allergy or hypersensitivity to statins or any of its components
- History of myositis or rhabdomyolysis with use of any statins
- Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids will be ineligible for 3 months after completion of therapy with the immunomodulating agents
- History of inflammatory muscle disease such as poly or dermatomyositis
- Serious intercurrent illness requiring systemic treatment and/or hospitalization within 30 days of entry
- Evidence of active opportunistic infections requiring treatment or neoplasms that require chemotherapy during the study period
- Creatine phosphokinase elevations (CPK) greater than 3 times the upper limit of normal
- Known active liver disease or AST/ALT greater than 2x the upper limit of normal
- Renal insufficiency, indicated by serum creatinine 2 mg/dl
- Absolute neutrophil count (ANC) 1000/mm3, hemoglobin \< 10.0 g/dL for males and \<9 g/dL for females, platelet count 100,000/mm
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01263938
Start Date
September 1 2011
End Date
October 1 2017
Last Update
May 1 2019
Active Locations (1)
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1
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104