Energy Expenditure of People Living With HIV/AIDS

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02530827
• Date of registration: 04/08/2015
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Energy Expenditure of People Living With HIV/AIDS
• Scientific title: Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure
• Date of first enrolment: March 2013
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02530827
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
• Phase: N/A

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV/AIDS

HIV Lipodystrophy Syndrome

Intervention(s)

Drug: use of lipid-lowering drugs.

Primary Outcome(s)

Resting Energy Expenditure (kcal/d) [Time Frame: 1 day]

Total Energy Expenditure (kcal/d) [Time Frame: 14 day]

Secondary Outcome(s)

Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI) [Time Frame: 14 days]

Secondary ID(s)

CAAE 01848612.1.0000.5440

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo