Progress Adult Study
This study is currently recruiting participants.
Verified April 2011 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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
- Signed consent form
- Age> 18 years
Exclusion Criteria:
- Patients who came for treatment in a department other than out patient, such as inpatient or emergency room.
- 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.
- Patients who have been diagnosed by doctors as a Psychological disorder that can not store the data.
- Patients who have been diagnosed by a medical condition that Alcoholism
Contacts and Locations
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 March 07, 2013
