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

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: Completed
• Conditions: HIV Infections

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: Observational
• Enrollment (Actual): 580

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Survey; Thai naive HIV-infected patients; Thai HIV-infected patient reciering highly active antiretroviral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The community screening tool	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

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: Chulalongkorn University; Mahidol University; World Health Organization; Ministry of Health, Thailand; Bamrasnaradura Infectious Diseases Institute; BNH Hospital
• Investigators: Principal Investigator: Dr. Wisit Prasithsirikul, Bamrasnaradura Infectious Disease Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Nutritional status; Nutritional situation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: TNT-HIV001