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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Bamrasnaradura Infectious Diseases Institute
Ministry of Health, Thailand
Mahidol University
Chulalongkorn University
BNH Hospital
Information provided by (Responsible Party):
Nittaya Phanuphak, M.D., Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:
NCT01899157
First received: June 6, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Nutritional Status Among naïve HIV-infected Patients and HIV-infected Patients Receiving Highly Active Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures:
  • Nutritional status and Nutritional situation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The prevalence of metabolic syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • The community screening tool [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 580
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Survey
  1. Thai naive HIV-infected patients
  2. Thai HIV-infected patient reciering highly active antiretroviral therapy

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899157

Locations
Thailand
Thai Red Cross AIDS Research Centre
Bangkok, Pathumwan, Thailand
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
World Health Organization
Bamrasnaradura Infectious Diseases Institute
Ministry of Health, Thailand
Mahidol University
Chulalongkorn University
BNH Hospital
Investigators
Principal Investigator: Dr. Wisit Prasithsirikul Bamrasnaradura Infectious Disease Institute
  More Information

No publications provided

Responsible Party: Nittaya Phanuphak, M.D., Dr., Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01899157     History of Changes
Other Study ID Numbers: TNT-HIV001
Study First Received: June 6, 2013
Last Updated: July 10, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Thai Red Cross AIDS Research Centre:
Nutritional status
Nutritional situation

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014