Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02530827
Other study ID # CAAE 01848612.1.0000.5440
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A
Completed NCT03643705 - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention N/A
Completed NCT03923231 - Pharmacokinetics of Atazanavir in Special Populations