Status:
COMPLETED
The Effect of Lopinavir/Ritonavir on Endothelial Function
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Healthy
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This study will examine how the anti-HIV protease inhibitor lopinavir/ritonavir (Kaletra® (Registered Trademark)) affects the function of the endothelium (lining of the arteries). Medications such as ...
Detailed Description
With the advent of the highly active antiretroviral (ARV) therapy era, patients with human immunodeficiency virus (HIV) have had significantly decreased mortality and morbidity. Concomitant with more ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18-40.
- Healthy by medical history and physical examination.
- Negative serum pregnancy test for females.
- Females willing to use two forms of birth control including barrier contraception during period of study (lopinavir/ritonavir decreases ethinyl estradiol levels).
- Able to provide informed consent.
- Laboratory values on screening visit within: AST less than 40 units/liter, serum creatinine less than 1.5mg/dl; CPK less than 387, hemoglobin greater than 11.0 g/dL (females) or greater than 12.6 g/dL (males), platelets greater than 154,000/mm(3), total bilirubin less than or equal to 1.5 mg/d
- Total cholesterol less than 200 mg/dL, LDL cholesterol less than 160 mg/dL, HDL cholesterol greater than 30mg/dL, triglycerides less than 200 mg/dL.
- Non-smoker or not having smoked for the past 6 weeks.
- Negative for HIV by ELISA within 4 weeks of study participation.
- EXCLUSION CRITERIA:
- Concomitant therapy with any prescription, over-the-counter or alternative medication except intermittent use of acetaminophen, non-steroidal anti-inflammatory medications, loperamide or oral contraceptives.
- Inability to obtain venous access for sample collection.
- Presence of diabetes mellitus or fasting blood sugar greater than 126 mg/dL, or abnormal oral glucose tolerance test (2 hour post blood sugar greater than 200 mg/dL).
- Human immunodeficiency virus (HIV) infection.
- Cardiac disease, congestive heart disease, coronary artery disease, angina, carotid stenosis, peripheral vascular disease, cerebrovascular disease, myocardial disease, clinically significant valvular heart disease.
- Any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigator.
- Hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg) on screening visit.
- Observed abnormalities on EKG tracings that are significant in the opinion of the investigator (examples include, AV block, multifocal atrial tachycardia, frequent premature ventricular contractions, etc.).
- Hypotension (systolic blood pressure less than 80 mmHG).
- Pregnant or breastfeeding female.
- Inability to abstain from caffeine use (coffee, tea or soda) or alcohol for 12 hours prior to a blood flow study until the conclusion of the study.
- Heavy alcohol ingestion (4 or more drinks a day) or current substance abuse.
- Hypo or hyper thyroidism.
- Allergy to lidocaine.
- History of hepatitis or other liver disease.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00076414
Start Date
January 1 2004
End Date
September 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, United States, 20892