Energy Expenditure of People Living With HIV/AIDS | NCT02530827

Studies
Energy Expenditure of People Living With HIV/AIDS

NCT02530827

Sponsor

University of Sao Paulo General Hospital

Status

Completed

Last Update Posted

Aug 21, 2015Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

HIV/AIDS
HIV Lipodystrophy Syndrome

Interventions

use of lipid-lowering drugs.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 20, 2015

First Posted Date

Aug 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2015

Last Update Posted Date

Aug 21, 2015Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

REE was measured by indirect calorimetry.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	LIPO+HIPO+

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Energy Expenditure (kcal/d)		14 day
Resting Energy Expenditure (kcal/d)		1 day

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Men previously diagnosed with HIV infection, on antiretroviral therapy.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D039682	HIV-Associated Lipodystrophy Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D058607	Fibric Acids

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided