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Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors

NCT ID: NCT00720590

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Participants will receive treatment with atazanavir and placebo lopinavir/ritonavir.

Group Type EXPERIMENTAL

Atazanavir

Intervention Type DRUG

400 mg of atazanavir (two 200-mg capsules) per day for 4 weeks

Placebo

Intervention Type DRUG

Daily dose of placebo for 4 weeks

2

Participants will receive treatment with lopinavir/ritonavir and placebo atazanavir.

Group Type EXPERIMENTAL

Lopinavir/ritonavir

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Daily dose of placebo for 4 weeks

3

Participants will receive treatment with placebos for both drugs.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily dose of placebo for 4 weeks

Interventions

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Atazanavir

400 mg of atazanavir (two 200-mg capsules) per day for 4 weeks

Intervention Type 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

Intervention Type DRUG

Placebo

Daily dose of placebo for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy and lean with normal lipids
* Not infected with HIV or viral hepatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Indiana University School of Medicine

Principal Investigators

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Michael P. Dubé, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Dube MP, Shen C, Greenwald M, Mather KJ. No impairment of endothelial function or insulin sensitivity with 4 weeks of the HIV protease inhibitors atazanavir or lopinavir-ritonavir in healthy subjects without HIV infection: a placebo-controlled trial. Clin Infect Dis. 2008 Aug 15;47(4):567-74. doi: 10.1086/590154.

Reference Type RESULT
PMID: 18636958 (View on PubMed)

Other Identifiers

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R01HL072711

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL072711-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

573

Identifier Type: -

Identifier Source: org_study_id