Effect of Nutritional Intervention on the Lipid Profile o... | NCT00429845

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

NCT00429845

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Feb 1, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Nutritional

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Feb 2007

First Submitted Date

Jan 30, 2007

First Submission Date that Met QC Criteria

Jan 31, 2007

First Posted Date

Feb 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2007

Last Update Posted Date

Feb 1, 2007Estimated

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Nutritional	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total cholesterol and of triglycerides levels

Secondary Outcomes

Measure	Description	Time Frame
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorge P Ribeiro, MD, ScD	Associate Professor and Chief of Non-invasive Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90035-003	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22402068	Derived	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.

ID	Term
D015658	HIV Infections
D050171	Dyslipidemias

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral