Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary abnormalities in HIV.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alison Morris; University of Pittsburgh
• Treatments: Calcium; Calcium, Dietary

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.