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Completed

NCT Number: NCT00429845

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

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

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional

Behavioral

Primary outcomes

  1. Total cholesterol and of triglycerides levels

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial

Important dates

Study start
2004
Study completion
2007
First posted
Feb 1, 2007
Registry last updated
Feb 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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