Nutritional Status Among naïve HIV Infected Patients and HIV Infected Patients Receiving Highly Active Antiretroviral Therapy (TNT-HIV 001)

July 10, 2013 updated by: Nittaya Phanuphak, M.D., Thai Red Cross AIDS Research Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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:

  1. 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.
  2. 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.
  3. To describe the prevalence of CVD and its relationship to cardiac risk factors
  4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumwan
      • Bangkok, Pathumwan, Thailand
        • Thai Red Cross Aids Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • HIV negative
  • Patient who had active AIDS-related disorders within three months before participate the study
  • Patients who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Survey
  1. Thai naive HIV-infected patients
  2. Thai HIV-infected patient reciering highly active antiretroviral therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prevalence of metabolic syndrome
Time Frame: 1 year
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
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The community screening tool
Time Frame: 1 year
To validate the community screening tool developed by the Thai Nutrition Task Force for HIV (TNT-HIV) by assessing the correlation of this tool and nutritional status.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thai Red Cross AIDS Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chulalongkorn University
Mahidol University
World Health Organization
Ministry of Health, Thailand
Bamrasnaradura Infectious Diseases Institute
BNH Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Wisit Prasithsirikul, Bamrasnaradura Infectious Disease Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNT-HIV001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings