Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Heart Disease; HIV Infections

Treatments: Drug: Placebo; Drug: Lovaza

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01001767

AIDS 10-08-24

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

35 participants in 2 patient groups, including a placebo group

Lovaza

Active Comparator group

Description:

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

Treatment:

Drug: Lovaza

Placebo

Placebo Comparator group

Description:

Placebo capsule by mouth twice a day x 24 weeks.

Treatment:

Drug: Placebo