Energy Expenditure of People Living With HIV/AIDS

NCT02530827 | Completed DMC

• 1 other identifier: CAAE 01848612.1.0000.5440
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV/AIDS; HIV Lipodystrophy Syndrome

Keywords

energy expenditure; doubly labeled water; accelerometer; HIV; lipodystrophy syndrome.

Outcome Measures

Primary Outcomes (2)

• Total Energy Expenditure (kcal/d)

  14 day

• Resting Energy Expenditure (kcal/d)

  1 day

Secondary Outcomes (1)

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

  14 days

Study Arms (3)

LIPO-HIPO-

HIV-seropositive without lipodystrophy and no use of lipid-lowering drugs.

LIPO+HIPO-

HIV-seropositive with lipodystrophy and no use of lipid-lowering drugs.

LIPO+HIPO+

HIV-seropositive with lipodystrophy and use of lipid-lowering drugs.

Drug: use of lipid-lowering drugs.

Interventions

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.

Also known as: statins and fibrates

LIPO+HIPO+

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Men previously diagnosed with HIV infection, on antiretroviral therapy.

You may qualify if:

• 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)

You may not qualify if:

• Signs or symptoms of opportunistic infections
• Thyroid disease

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

urine.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV-Associated Lipodystrophy Syndrome

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Fibric Acids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 21, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 21, 2015

Record last verified: 2015-08