Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men (PERTH)

Tufts University

Status: Completed

Conditions: HIV Infection; Cardiovascular Risk; HIV Infections

Treatments: Other: Saturated fat study meal; Other: Omega-3 study meal

Study type: Observational

Funder types: Other

Identifiers

NCT00846599

SUB730

Details and patient eligibility

About

The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.

Full description

This study requires two visits. Once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. The participant will receive the other study meal during the second visit. At each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. The sample size is 50 subjects. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV-positive white male aged >18 years

• Under one of the following treatment categories:

  • Treatment naive or have never taken any HIV medications
  • Taking Kaletra
  • Taking Sustiva
  • Taking Atripla

Exclusion criteria

• Smoker

• Pre-existing diagnosis or treatment for the following:

  • Lipid disorder
  • Cardiovascular disease
  • High blood pressure
  • Diabetes

• Acute opportunistic infection or malignancy within last 3 months or current therapy for either

• Active IV drug use

Trial design

50 participants in 2 patient groups

1

Description:

High omega-3

Treatment:

Other: Omega-3 study meal

2

Description:

High saturated fat

Treatment:

Other: Saturated fat study meal