Progress Adult Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bamrasnaradura Institute
Sanpatong Hospital
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01328275
First received: March 2, 2011
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention
HIV
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: December 2020
Estimated Primary Completion Date: December 2020 (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

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330
Sanpatong Hospital
Chiang Mai, Thailand
Bamrasnaradura infectious disease institute
Nonthaburi, Thailand, 11000
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: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01328275     History of Changes
Other Study ID Numbers: HIV-NAT 153
Study First Received: March 2, 2011
Last Updated: March 27, 2015
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

ClinicalTrials.gov processed this record on May 29, 2015