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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Nutritional

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No