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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, HAART, Nutrition, Dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Outcomes

Primary Outcome Measures

Total cholesterol and of triglycerides levels

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2007
Last Updated
January 31, 2007
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT00429845
Brief Title
Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial
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 Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, HAART, Nutrition, Dyslipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Nutritional
Primary Outcome Measure Information:
Title
Total cholesterol and of triglycerides levels
Secondary Outcome Measure Information:
Title
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge P Ribeiro, MD, ScD
Organizational Affiliation
Associate Professor and Chief of Non-invasive Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22402068
Citation
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.
Results Reference
derived

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

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