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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:
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

June 6, 2013
July 10, 2013
August 2009
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01899157 on ClinicalTrials.gov Archive Site
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
Same as current
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.
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01899157
TNT-HIV001
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP