ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00429845
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : February 1, 2007
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Nutritional Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Total cholesterol and of triglycerides levels

Secondary Outcome Measures :
  1. HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

ClinicalTrials.gov Identifier: NCT00429845     History of Changes
Other Study ID Numbers: HCPA2004-012
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 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