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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
Endpoint Classification: Efficacy Study
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:

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
Genders Eligible for Study:   Both
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
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

No publications provided

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

Keywords provided by Hospital de Clinicas de Porto Alegre:
HIV
HAART
Nutrition
Dyslipidemia

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Food Habits
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Habits

ClinicalTrials.gov processed this record on May 16, 2013