Energy Expenditure of People Living With HIV/AIDS

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530827
• Other study ID #: CAAE 01848612.1.0000.5440
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: August 20, 2015
• Start date: March 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

REE was measured by indirect calorimetry.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Lipodystrophy Syndrome
• HIV-Associated Lipodystrophy Syndrome
• HIV/AIDS
• Lipodystrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Energy Expenditure (kcal/d)		14 day	No
Primary	Resting Energy Expenditure (kcal/d)		1 day	No
Secondary	Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)		14 days	No