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

January 30, 2007
January 31, 2007
March 2004
Not Provided
Total cholesterol and of triglycerides levels
Same as current
Complete list of historical versions of study NCT00429845 on ClinicalTrials.gov Archive Site
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio
Same as current
Not Provided
Not Provided
 
Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial
Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial

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.

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)
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Behavioral: Nutritional
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
February 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00429845
HCPA2004-012
Not Provided
Not Provided
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Jorge P Ribeiro, MD, ScD Associate Professor and Chief of Non-invasive Cardiology
Hospital de Clinicas de Porto Alegre
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP