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
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 |
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.
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo |
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 |
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