Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-06-30

Brief Summary

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Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

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Detailed Description

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Conditions

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HIV Infections Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lovaza

Lovaza 1 gram by mouth twice a day for 24 weeks.

Group Type ACTIVE_COMPARATOR

Lovaza

Intervention Type DRUG

Lovaza one gram twice a day for 24 weeks

Placebo

Placebo capsule by mouth twice a day x 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Lovaza

Lovaza one gram twice a day for 24 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Omega-3 fatty acid

Eligibility Criteria

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Inclusion Criteria

* HIV+
* Ages 18-70
* HIV-1 RNA \<400 copies/ml.
* On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos.

Exclusion Criteria

* Active infection
* Inflammation or malignancy
* Uncontrolled diabetes or hypothyroidism
* LDL (low density lipoprotein) cholesterol \>160 and triglyceride levels \>750
* Framingham risk score \<6.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No