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

This study has been completed.

Sponsor:

Information provided by:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT00429845

First received: January 30, 2007

Last updated: January 31, 2007

Last verified: January 2007

History of Changes

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Nutritional


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:

Total cholesterol and of triglycerides levels

Secondary Outcome Measures:

HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio


Estimated Enrollment:	80
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2007

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)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429845

Locations


Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators


Principal Investigator:	Jorge P Ribeiro, MD, ScD	Associate Professor and Chief of Non-invasive Cardiology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lazzaretti RK, Kuhmmer R, Sprinz E, Polanczyk CA, Ribeiro JP. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1-infected individuals: a randomized trial. J Am Coll Cardiol. 2012 Mar 13;59(11):979-88. doi: 10.1016/j.jacc.2011.11.038.


ClinicalTrials.gov Identifier:	NCT00429845 History of Changes
Other Study ID Numbers:	HCPA2004-012
Study First Received:	January 30, 2007
Last Updated:	January 31, 2007

Keywords provided by Hospital de Clinicas de Porto Alegre:


HIV HAART Nutrition Dyslipidemia

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on June 29, 2017

To Top