Nutritional Status Among naïve HIV Infected Patients and HIV Infected Patients Receiving Highly Active Antiretroviral Therapy

HIV Infections Clinical Trial

— TNT-HIV 001  

Official title:

Nutritional Status Among naïve HIV-infected Patients and HIV-infected Patients Receiving Highly Active Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899157
• Other study ID #: TNT-HIV001
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: July 10, 2013
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Thailand	Thai Red Cross AIDS Research Centre	Bangkok	Pathumwan

Sponsors (7)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Bamrasnaradura Infectious Diseases Institute, BNH Hospital, Chulalongkorn University, Mahidol University, Ministry of Health, Thailand, World Health Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No