Trial record 13 of 33 for:    " February 09, 2011":" March 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Progress Adult Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
Collaborators:
Bamrasnaradura Institute
Sanpatong Hospital
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01328275
First received: March 2, 2011
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention
Acquired Immunodeficiency Syndrome
Depression
Drug: standard regimens according to the Thai Ministry of Public Health national guidelines

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai HIV Disease Progression: An Observational Database

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • HIV related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Time until patient has HIV related adverse events


Secondary Outcome Measures:
  • Immunological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to immunological failure

  • virological failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to virological failure

  • the change of quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    time to change of quality of life

  • depression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    time when patient develops depression

  • genotypic resistance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    time to developing genotypic resistance


Biospecimen Retention:   Samples With DNA

serum


Estimated Enrollment: 5600
Study Start Date: December 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
long-term follow-up of HIV-infected patients on ART
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-infected patients currently receiving ART at Bamrasnaradura Institute, Sanpatong Hospital or HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328275

Contacts
Contact: Wisit Prasithsirikul, MD 6625903408 drwisit_p@yahoo.com
Contact: Jintanat Ananworanich, MD, PHD 662-652-3040 ext 280 jintanat.a@hivnat.org

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Jintanat Ananworanich, MD, PhD    662-652-3040 ext 280    jintanat.a@hivnat.org   
Principal Investigator: Jintanat Ananworanich, MD, PhD         
Sanpatong Hospital Recruiting
Chiang Mai, Thailand
Contact: Wirat Klinbuayam, MD         
Principal Investigator: Wirat Klinbuayam, MD         
Bamrasnaradura infectious disease institute Recruiting
Nonthaburi, Thailand, 11000
Contact: Wisit Prasithsirikul, MD         
Principal Investigator: Wisit Prasithsirikul, MD         
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Bamrasnaradura Institute
Sanpatong Hospital
Investigators
Principal Investigator: Wisit Prasithsirikul, MD Bamrasnaradura infectious disease institute
Principal Investigator: Wirat Klinbuayam, MD Sanpatong Hospital
Principal Investigator: Jintanat Ananworanich, MD, PhD HIV-NAT, Thai Red Cross AIDS Research Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Wisit Prasithsirikul, Bamrasnaradura Infectious Disease Institute
ClinicalTrials.gov Identifier: NCT01328275     History of Changes
Other Study ID Numbers: HIV-NAT 153
Study First Received: March 2, 2011
Last Updated: April 1, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV related adverse events
immunological failure
virological failure
quality of life
depression
genotypic resistance

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Depression
Depressive Disorder
Immunologic Deficiency Syndromes
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014