Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00429845
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART.

Detailed Description

Adult patients prescribed to HAART that met the exclusion criteria were consecutively enrolled in a randomized trial:

* control (receiving general guidelines on dietary education)

* intervention (receiving general guidelines on dietary education and nutritional follow-up every 3 months)

Study Timeline

• Study Start: 2004-03
• Status Verified: 2007-01
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-31
• Last Update Submitted: 2007-01-31
• Study Completion: 2007-02
• Study First Posted: 2007-02-01
• Last Update Posted: 2007-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• HIV-positive individuals naive to HAART, with clinical indication to start therapy

Exclusion Criteria

• Diabetes Mellitus
• Pregnancy
• Active opportunistic disease
• Any mental deficiency
• Use of lipid profile influencing drugs
• Use of illicit drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total cholesterol and of triglycerides levels

Secondary Outcome Measures

Name	Time	Method
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil