HIV/AIDSNCT02530827
Energy Expenditure of People Living With HIV/AIDS
An observational study of HIV/AIDS and HIV Lipodystrophy Syndrome, run by University of Sao Paulo General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- HIV/AIDS, HIV Lipodystrophy Syndrome
- What is being tested?
- use of lipid-lowering drugs.
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Men previously diagnosed with HIV infection, on antiretroviral therapy.
Who may be able to join
- 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)
Who cannot join
- Signs or symptoms of opportunistic infections
- Thyroid disease
About this study
Official title: Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure
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.
Read the 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).
- Conditions
- HIV/AIDS, HIV Lipodystrophy Syndrome
- Being tested
- use of lipid-lowering drugs.
- Keywords
- energy expenditure, doubly labeled water, accelerometer, HIV, lipodystrophy syndrome.
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of lipid-lowering drugs.Drug
Also called statins and fibrates
The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: use of lipid-lowering drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Energy Expenditure (kcal/d)
Measured: 14 day
Resting Energy Expenditure (kcal/d)
Measured: 1 day
Secondary outcomes (1)
Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530827
- Sponsor's protocol ID
- CAAE 01848612.1.0000.5440
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure
- ClinicalTrials.gov ID
- NCT02530827
- Acronym / sponsor ID
- CAAE 01848612.1.0000.5440
- Conditions
- HIV/AIDS, HIV Lipodystrophy Syndrome
- Keywords
- energy expenditure, doubly labeled water, accelerometer, HIV, lipodystrophy syndrome.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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+ | – | Drug: use of lipid-lowering drugs.HIV-seropositive with lipodystrophy and use of lipid-lowering drugs. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Men previously diagnosed with HIV infection, on antiretroviral therapy.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Signs or symptoms of opportunistic infections
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of lipid-lowering drugs.Also: statins and fibratesThe patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study. | Drug | LIPO+HIPO+ |
Primary outcome
Total Energy Expenditure (kcal/d)
Time frame: 14 day
Resting Energy Expenditure (kcal/d)
Time frame: 1 day
1 secondary outcome
Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and HIV Lipodystrophy Syndrome, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Energy Expenditure (kcal/d) (time frame: 14 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.