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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01328275
Other study ID # HIV-NAT 153
Secondary ID
Status Completed
Phase N/A
First received March 2, 2011
Last updated May 9, 2016
Start date December 2007
Est. completion date June 2015

Study information

Verified date May 2016
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult.


Description:

This is a multicenter, observational prospective cohort study. All HIV-infected patients from Bamrasnaradura Institute, Sanpatong Hospital and HIV-NAT, Thai Red Cross AIDS Research Centre, are followed to assess HIV disease progression.


Recruitment information / eligibility

Status Completed
Enrollment 5600
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. There is evidence that HIV infection true (blood positive results by ELISA (ELISA) has been confirmed or detected evidence co-infection. HIV in the body by PCR, HIV-RNA PCR).Currently on PI regimens

2. Signed consent form

3. Age> 18 years

Exclusion Criteria:

1. Patients who came for treatment in a department other than out patient, such as inpatient or emergency room.

2. Patients are not willing to receive treatment on a regular basis in all 3 hospitals as patients normally receive treatment at other hospitals on a regular basis. However, due to urgent events. Need to receive treatment in hospital and three of.

3. Patients who have been diagnosed by doctors as a Psychological disorder that can not store the data.

4. Patients who have been diagnosed by a medical condition that Alcoholism

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
standard regimens according to the Thai Ministry of Public Health national guidelines
Participants may receive any of the standard regimens. These regimens are recommended in the Thai Ministry of Public Health National guidelines for the treatment of HIV in children. Change of treatment will be according to the treating physicians.

Locations

Country Name City State
Thailand HIV-NAT, Thai Red Cross AIDS Research Centre Bangkok
Thailand Sanpatong Hospital Chiang Mai
Thailand Bamrasnaradura infectious disease institute Nonthaburi

Sponsors (3)

Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration Bamrasnaradura Infectious Diseases Institute, Sanpatong Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary HIV related adverse events Time until patient has HIV related adverse events 1 year Yes
Secondary Immunological failure time to immunological failure 1 year Yes
Secondary virological failure time to virological failure 1 year Yes
Secondary the change of quality of life time to change of quality of life 1 year No
Secondary depression time when patient develops depression 1 year No
Secondary genotypic resistance time to developing genotypic resistance 1 year Yes
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