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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: HIV Seropositivity

In brief

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

Key facts

Study ID

NCT01881971

Run by

Alison Morris

People needed

23

Starts

2013-05-01

Expected to finish

2016-01-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angelos — Los Angeles, California, United States
• University of California, SF — San Francisco, California, United States
• University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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