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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:
ClinicalTrials.gov Identifier:
NCT01899157
First Posted: July 15, 2013
Last Update Posted: July 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
June 6, 2013
July 15, 2013
July 15, 2013
August 2009
December 2010   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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
Same as current
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.
Same as current
 
Nutritional Status Among naïve HIV Infected Patients and HIV Infected Patients Receiving Highly Active Antiretroviral Therapy
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.

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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
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.
HIV Infections
Not Provided
Survey
  1. Thai naive HIV-infected patients
  2. Thai HIV-infected patient reciering highly active antiretroviral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
580
December 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01899157
TNT-HIV001
No
Not Provided
Not Provided
Nittaya Phanuphak, M.D., Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre
  • World Health Organization
  • Bamrasnaradura Infectious Diseases Institute
  • Ministry of Health, Thailand
  • Mahidol University
  • Chulalongkorn University
  • BNH Hospital
Principal Investigator: Dr. Wisit Prasithsirikul Bamrasnaradura Infectious Disease Institute
Thai Red Cross AIDS Research Centre
July 2013