NCT00429845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 1, 2007

Status Verified

January 1, 2007

First QC Date

January 30, 2007

Last Update Submit

January 31, 2007

Conditions

HIV Infections

Keywords

HIVHAARTNutritionDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Total cholesterol and of triglycerides levels

Secondary Outcomes (1)

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

Interventions

NutritionalBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-positive individuals naive to HAART, with clinical indication to start therapy

You may not qualify if:

  • Diabetes Mellitus
  • Pregnancy
  • Active opportunistic disease
  • Any mental deficiency
  • Use of lipid profile influencing drugs
  • Use of illicit drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 22402068DERIVED

MeSH Terms

Conditions

HIV InfectionsDyslipidemias

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jorge P Ribeiro, MD, ScD

    Associate Professor and Chief of Non-invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

March 1, 2004

Study Completion

February 1, 2007

Last Updated

February 1, 2007

Record last verified: 2007-01

Locations

BR(1)