Skip to main content
OpenTrials
Completed

NCT Number: NCT02530827

Energy Expenditure of People Living With HIV/AIDS

Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome.

The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Lipodystrophy Syndrome HIV-Associated Lipodystrophy Syndrome Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

About this study

REE was measured by indirect calorimetry.

TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Use of antiretroviral therapy for at least 4 months
  • A cluster of differentiation 4 (CD4) T-cell count of >200 cells/mm3
  • Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering)

Exclusion criteria

  • Signs or symptoms of opportunistic infections
  • Thyroid disease

Treatment and study plan

use of lipid-lowering drugs.

Drug

The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.

Other names: statins and fibrates

Primary outcomes

  1. Total Energy Expenditure (kcal/d)

    Time frame: 14 day

  2. Resting Energy Expenditure (kcal/d)

    Time frame: 1 day

Secondary outcomes

  1. Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2015
Registry last updated
Aug 21, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.