Status:
COMPLETED
Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center
Lead Sponsor:
Alison Morris
Conditions:
HIV Seropositivity
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.
Detailed Description
Growing evidence indicates that chronic obstructive pulmonary disease (COPD) is an important cause of respiratory impairment in HIV+ persons and will likely increase as the HIV+ population continues t...
Eligibility Criteria
Inclusion
- HIV-1 infection, documented in medical record at any time prior to study entry.
- Men and women age18 years to 80 years.
- Presence of COPD (FEV1/FVC\<0.70 or DLco≤80% predicted)
- No lipid-lowering medication (prescription or non-prescription) within 60 days prior to study entry. This includes all statin drugs, omega-3-fatty acids/fish oil (if dose \> 1 g/day), red yeast rice (any dose), and niacin products (e.g., niacin, nicotinic acid, vitamin B3; if dose of \>100 mg/day)
- Normal liver and kidney function test at screening visit:
- Liver function: ALT 7 to 55 U/L; AST 8 to 48 U/L; ALP 45 to 115 U/L; Bilirubin 0.1 to 1.0 mg/dL; GGT 9 to 48 U/L; LDH 122 to 222 umol/L; PT 8.3 to 10.8 seconds
- Kidney function: BUN 8-20 mg/dl. Creatinine 0.8-1.2 mg/dl for males and 0.6-0.9 mg/dl for females. GFR normal results range from 90 - 120 mL/min/1.73 m2.) Participants will be on a stable ART regimen (i.e. no change in agents) with either suppressed HIV viral level or \<50 viral level for at least 3 months.
- If smoker, not planning on quitting smoking during the study period. If non-smoker, not planning on starting smoking during the study period.
- Able to provide informed consent.
- Able to participate in study procedures based on the investigator's assessment.
- For women of reproductive potential, negative urine pregnancy test and willingness to use birth control during study period (see Contraception requirements).
- Ability and willingness to complete all tests.
- Participant in MACS, Women's Interagency Health Study, or Attendee of UPMC HIV / AIDS Program.
Exclusion
- Pregnancy or breast-feeding.
- Known allergy/sensitivity or any hypersensitivity to HMG CoA reductase inhibitors, prior history of myopathy, rhabdomyolysis, or intolerance of statin therapy.
- Currently receiving a statin or should be taking a statin based on clinical criteria.
- Concurrent use of Coumadin.
- History of liver disease.
- Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
- Diagnosis of asthma with normal diffusing capacity.
- History of diabetes mellitus requiring medication of hemoglobin A1C\>6.5% on screening laboratories.
- Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
- Hospitalization within 4 weeks prior to study entry.
- Use of antibiotics within 4 weeks of study entry.
- Uncontrolled hypertension at screening visit (systolic \> 160 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
- Active cancer requiring systemic chemotherapy or radiation.
- Active infection of lungs, brain, or abdomen.
- Use of anti-inflammatory agents (such as aspirin), immunomodulators (e.g., interleukins, interferons, cyclosporine) or immunosuppressive medications within 60 days prior to study entry. Routine vaccinations are allowed if administered at least 7 days prior to study entry.
- Use of azole antifungals, erythromycin, or amiodarone.
- More than weekly use of magnesium hydroxide.
- The intention to quit smoking during the study period.
- Alcoholism defined as \>35 drinks per week or that will impair ability to complete study investigations in the opinion of the investigator.
- Active (within the past 6 months) intravenous drug use or that will impair ability to complete study investigations in the opinion of the investigator.
- Use of other investigational agents within 90 days of study entry or planning on entering another therapy trial during study period.
- No use of inhaled corticosteroids (beta-agonists are allowed).
- Viral load above 50 in past 3 months.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01881971
Start Date
May 1 2013
End Date
January 1 2016
Last Update
October 8 2020
Active Locations (3)
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1
University of California, Los Angelos
Los Angeles, California, United States, 90095
2
University of California, SF
San Francisco, California, United States, 94118
3
University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine
Pittsburgh, Pennsylvania, United States, 15213