HIV InfectionsTNT-HIV 001NCT01899157
Nutritional Status Among naïve HIV Infected Patients and HIV Infected Patients Receiving Highly Active Antiretroviral Therapy
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
A prospective cross-sectional study evaluates nutritional status and its relationship to the related factors in Thai HIV-infected patients who attending in out patient clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 580 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2009to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 580 Thai HIV-infected patients who either did or did not receive treatment with antiretroviral therapy at The Thai Red Cross AIDS Research Centre, Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha.; These participants will be enrolled at TRCARC and Bamrasnaradura Infectious Disease Institute for amount 300 HIV infected patients and 70 HIV infected patients from each 4 region hospital.
Who may be able to join
- HIV positive
- 18 years of age or older
- Receiving ongoing care as part of the anonymous clinic, TRCARC, the antiretroviral therapy clinics at Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha.
- Either naïve HIV-infected patients and HIV-infected patients undergoing HARRT
Who cannot join
- HIV negative
- Patient who had active AIDS-related disorders within three months before participate the study
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Status Among naïve HIV-infected Patients and HIV-infected Patients Receiving Highly Active Antiretroviral Therapy
A prospective cross-sectional study evaluates nutritional status and its relationship to the related factors in Thai HIV-infected patients who attending in out patient clinic.
Read the detailed description
A prospective cross-sectional study evaluates nutritional status and its relationship to the related factors in Thai HIV-infected patients who attending in out patient clinic at The Thai Red Cross AIDS Research Centre, Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha .
General Objective: To determine nutritional status among Thai People Living with HIV (PLHIV).
Specific Objective:
- To assess nutritional problems including undernutrition, overnutrition and others such as lipodystrophy, dyslipidemia, hyperglycemia, cardiovascular disease, etc. among naïve HIV-infected patients and HIV-infected patients undergoing HARRT by using ABCDEF approach: Anthropometric, Biochemical, Clinical, Dietary, Exercise and Family assessment.
- To describe the relationship between the nutritional status and HIV disease staging and other related factors among naïve HIV-infected patients and HIV-infected patients undergoing HARRT.
- To describe the prevalence of CVD and its relationship to cardiac risk factors
- To validate the community screening tool developed by the Thai Nutrition Taskforce in HIV (TNT-HIV) by assessing the correlation of this tool and nutritional status.
- Conditions
- HIV Infections
- Keywords
- Nutritional status, Nutritional situation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survey | 1. Thai naive HIV-infected patients 2. Thai HIV-infected patient reciering highly active antiretroviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status and Nutritional situation
Nutritional status and Nutritional situation in Naïve HIV infected patients and HIV-infected patients undergoing HAART. It will be collected by using ABCDEF approch: Anthropometric, Biochemistry, Clinical, Dietary, Exercise and Family assesment.
Measured: 1 year
Secondary outcomes (1)
The prevalence of metabolic syndrome
The prevalence of metabolic syndrome in Naïve HIV infected patients and HIV-infected patients undergoing HARRT using American Heart Association (AHA) and National Heart Lung and Blood Institute (NHLBI) criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Bamrasnaradura Infectious Diseases Institute, Ministry of Health, Thailand, Mahidol University, Chulalongkorn University, BNH Hospital
- Responsible party
- Principal investigator, Nittaya Phanuphak, M.D., Thai Red Cross AIDS Research Centre
- Investigators
- Dr. Wisit Prasithsirikul, Principal investigator, Bamrasnaradura Infectious Disease Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899157
- Sponsor's protocol ID
- TNT-HIV001
- Acronym
- TNT-HIV 001
- Status last verified
- Jul 2013
- First submitted
- 6 Jun 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Among naïve HIV-infected Patients and HIV-infected Patients Receiving Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT01899157
- Acronym / sponsor ID
- TNT-HIV 001 / TNT-HIV001
- Conditions
- HIV Infections
- Keywords
- Nutritional status, Nutritional situation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- World Health Organization, Bamrasnaradura Infectious Diseases Institute, Ministry of Health, Thailand, Mahidol University, Chulalongkorn University, BNH Hospital
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jul 2013 (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.
A prospective cross-sectional study evaluates nutritional status and its relationship to the related factors in Thai HIV-infected patients who attending in out patient clinic.
Detailed description
A prospective cross-sectional study evaluates nutritional status and its relationship to the related factors in Thai HIV-infected patients who attending in out patient clinic at The Thai Red Cross AIDS Research Centre, Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha .
General Objective: To determine nutritional status among Thai People Living with HIV (PLHIV).
Specific Objective:
- To assess nutritional problems including undernutrition, overnutrition and others such as lipodystrophy, dyslipidemia, hyperglycemia, cardiovascular disease, etc. among naïve HIV-infected patients and HIV-infected patients undergoing HARRT by using ABCDEF approach: Anthropometric, Biochemical, Clinical, Dietary, Exercise and Family assessment.
- To describe the relationship between the nutritional status and HIV disease staging and other related factors among naïve HIV-infected patients and HIV-infected patients undergoing HARRT.
- To describe the prevalence of CVD and its relationship to cardiac risk factors
- To validate the community screening tool developed by the Thai Nutrition Taskforce in HIV (TNT-HIV) by assessing the correlation of this tool and nutritional status.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | – | –1. Thai naive HIV-infected patients 2. Thai HIV-infected patient reciering highly active antiretroviral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 580 Thai HIV-infected patients who either did or did not receive treatment with antiretroviral therapy at The Thai Red Cross AIDS Research Centre, Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha.; These participants will be enrolled at TRCARC and Bamrasnaradura Infectious Disease Institute for amount 300 HIV infected patients and 70 HIV infected patients from each 4 region hospital.
Key inclusion criteria (4 listed)
- HIV positive
- 18 years of age or older
- Receiving ongoing care as part of the anonymous clinic, TRCARC, the antiretroviral therapy clinics at Bamrasnaradura Infectious Disease Institute, Surat Thani hospital, Khonkaen hospital, Sanpathong hospital and the Queen Savang Vadhana Hospital at Sri Racha.
- Either naïve HIV-infected patients and HIV-infected patients undergoing HARRT
Key exclusion criteria (3 listed)
- HIV negative
- Patient who had active AIDS-related disorders within three months before participate the study
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional status and Nutritional situation
Time frame: 1 year
Nutritional status and Nutritional situation in Naïve HIV infected patients and HIV-infected patients undergoing HAART. It will be collected by using ABCDEF approch: Anthropometric, Biochemistry, Clinical, Dietary, Exercise and Family assesment.
1 secondary outcome
The prevalence of metabolic syndrome
Time frame: 1 year
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 15 Jul 2013.
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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.
Dr. Wisit Prasithsirikul principal investigator
Bamrasnaradura Infectious Disease Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
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 4 inclusion and 3 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 15 Jul 2013. 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 Thailand. 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?
Nutritional status and Nutritional situation (time frame: 1 year). 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 15 Jul 2013.