Clinical trial NCT01899157: Nutritional Status Among naïve HIV Infected Patients and HIV Infected Patients Receiving Highly Active Antiretroviral Therapy
Official title: Nutritional Status Among naïve HIV-infected Patients and HIV-infected Patients Receiving Highly Active Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Nutritional status
Nutritional situation
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Bamrasnaradura Infectious Diseases Institute
name: Ministry of Health, Thailand
name: Mahidol University
name: Chulalongkorn University
name: BNH Hospital
First posted: 2013-07-15
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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 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

Primary outcomes:
measure: Nutritional status and Nutritional situation
timeFrame: 1 year
Secondary outcomes:
measure: The prevalence of metabolic syndrome
timeFrame: 1 year
Other outcomes:
measure: The community screening tool
timeFrame: 1 year
Locations:
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre
state: Pathumwan
Study officials:
affiliation: Bamrasnaradura Infectious Disease Institute
name: Dr. Wisit Prasithsirikul
role: PRINCIPAL_INVESTIGATOR
References: