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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00720590 |
HIV protease inhibitors (PIs) are a class of antiretroviral drugs used to inhibit viral replication. They do so by interfering with a key step in the replication process. Some HIV PIs have been associated with an increased risk of adverse cardiovascular side effects. Further study is needed, however, to assess the full extent of effect of newer HIV PIs, including atazanavir and lopinavir/ritonavir, on cardiovascular disease risk. This study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors in healthy people without HIV.
Condition | Intervention |
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Endothelial Dysfunction |
Drug: Atazanavir Drug: Lopinavir/ritonavir Drug: Placebo |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Effect of HIV-1 Protease Inhibitors on Endothelial Function and Glucose Metabolism in Normal, HIV-Uninfected Subjects: Atazanavir or Lopinavir/Ritonavir or Placebo |
Enrollment: | 30 |
Study Start Date: | November 2003 |
Study Completion Date: | October 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive treatment with atazanavir and placebo lopinavir/ritonavir.
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Drug: Atazanavir
400 mg of atazanavir (two 200-mg capsules) per day for 4 weeks
Drug: Placebo
Daily dose of placebo for 4 weeks
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2: Experimental
Participants will receive treatment with lopinavir/ritonavir and placebo atazanavir.
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Drug: Lopinavir/ritonavir
400 mg/100 mg of lopinavir/ritonavir (three soft-gel capsules, each containing 133.3 mg lopinavir and 33.3 mg ritonavir) twice per day with food for 4 weeks
Drug: Placebo
Daily dose of placebo for 4 weeks
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3: Placebo Comparator
Participants will receive treatment with placebos for both drugs.
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Drug: Placebo
Daily dose of placebo for 4 weeks
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Antiretroviral therapy for HIV, particularly with the use of PIs, is associated with an increased risk of heart attack. Specific cardiovascular side effects seen with the use of some PIs include insulin resistance, abnormal blood lipid levels, and endothelial dysfunction (abnormalities in the cells that line the inner surface of blood vessels). Past studies have shown that treatment with indinavir, an older PI, results in significant endothelial dysfunction, which may be the main cause for the increase in cardiovascular risk. Indinavir is now seldom used in clinical practice, and the newer PIs atazanavir and combination lopinavir/ritonavir now account for nearly 70% of total PI use in the United States. It is not known what effect these new PIs have on endothelial dysfunction. This study will compare the effects of atazanavir, lopinavir/ritonavir, and placebo on certain cardiovascular disease risk factors, including abnormal glucose metabolism and endothelial dysfunction, in healthy people without HIV.
Participation in this study will last 4 weeks. All participants will undergo initial assessments that will include various vascular and metabolic evaluations. Body weight, height, basal heart rate, and systolic and diastolic blood pressure will also be measured. Participants will then be assigned randomly to receive 4 weeks of treatment with 400 mg of atazanavir per day plus placebo, 400 mg/100 mg of lopinavir/ritonavir twice per day plus placebo, or placebos for both drugs per day. Upon completing the 4 weeks of treatment, participants will repeat the initial assessments.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Michael P. Dubé, MD | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Michael P. Dubé, MD ) |
Study ID Numbers: | 573, R01 HL072711-01 |
Study First Received: | July 21, 2008 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00720590 |
Health Authority: | United States: Federal Government |
Lopinavir Ritonavir HIV Infections Acquired Immunodeficiency Syndrome Atazanavir |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Diseases Antiviral Agents Pharmacologic Actions Protease Inhibitors |