HIV InfectionsNCT00429845
Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial
A study testing Nutritional in people with HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nutritional
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2004to Feb 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive individuals naive to HAART, with clinical indication to start therapy
Who cannot join
- Diabetes Mellitus
- Pregnancy
- Active opportunistic disease
- Any mental deficiency
- Use of lipid profile influencing drugs
- Use of illicit drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial
Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART.
Read the detailed description
Adult patients prescribed to HAART that met the exclusion criteria were consecutively enrolled in a randomized trial:
- control (receiving general guidelines on dietary education)
- intervention (receiving general guidelines on dietary education and nutritional follow-up every 3 months)
- Conditions
- HIV Infections
- Being tested
- Nutritional
- Keywords
- HIV, HAART, Nutrition, Dyslipidemia
- Medical subject headings
- HIV Infections, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionalBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol and of triglycerides levels
Secondary outcomes (1)
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startMar 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Jorge P Ribeiro, MD, ScD, Principal investigator, Associate Professor and Chief of Non-invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429845
- Sponsor's protocol ID
- HCPA2004-012
- Status last verified
- Jan 2007
- First submitted
- 30 Jan 2007
- Last updated
- 1 Feb 2007
- Results posted
- No
Publications
Lazzaretti RK, Kuhmmer R, Sprinz E, Polanczyk CA, Ribeiro JP. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1-infected individuals: a randomized trial. J Am Coll Cardiol. 2012 Mar 13;59(11):979-88. doi: 10.1016/j.jacc.2011.11.038.
PubMed 22402068
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00429845
- Acronym / sponsor ID
- HCPA2004-012
- Conditions
- HIV Infections
- Keywords
- HIV, HAART, Nutrition, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Feb 2007
- First posted
- 1 Feb 2007 (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.
Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART.
Detailed description
Adult patients prescribed to HAART that met the exclusion criteria were consecutively enrolled in a randomized trial:
- control (receiving general guidelines on dietary education)
- intervention (receiving general guidelines on dietary education and nutritional follow-up every 3 months)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-positive individuals naive to HAART, with clinical indication to start therapy
Key exclusion criteria (6 listed)
- Diabetes Mellitus
- Pregnancy
- Active opportunistic disease
- Any mental deficiency
- Use of lipid profile influencing drugs
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 |
|---|---|---|
| Nutritional | Behavioural | – |
Primary outcome
Total cholesterol and of triglycerides levels
1 secondary outcome
HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio
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 1 Feb 2007.
- Derived from this study: PubMed 22402068Lazzaretti RK, Kuhmmer R, Sprinz E, Polanczyk CA, Ribeiro JP. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1-infected individuals: a randomized trial. J Am Coll Cardiol. 2012 Mar 13;59(11):979-88. doi: 10.1016/j.jacc.2011.11.038.
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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.
Jorge P Ribeiro, MD, ScD principal investigator
Associate Professor and Chief of Non-invasive Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional in people with HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 6 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 1 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 cholesterol and of triglycerides levels. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429845, which also lists 1 linked publication.
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 1 Feb 2007.