NCT01328288

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

6.7 years

First QC Date

March 2, 2011

Last Update Submit

February 19, 2016

Conditions

HIVDepression

Keywords

HIV related adverse eventsImmunological failurevirological failurequality of lifedepressiongenotypic resistance

Outcome Measures

Primary Outcomes (1)

  • HIV related adverse events

    time to HIV related adverse events

    1 year

Secondary Outcomes (5)

  • Immunological failure

    1 year

  • virological failure

    1 year

  • quality of life

    1 year

  • depression

    1 year

  • genotypic resistance

    1 year

Study Arms (1)

1

long-term follow-up of HIV-infected children

Drug: standard ART according to the Thai Ministry of Public Health national guidelines

Interventions

standard ART according to the Thai Ministry of Public Health national guidelinesDRUG

Patients 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.

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

long-term follow-up of HIV-infected children from: 1. Bamrasnaradura infectious disease institute, 2. Faculty of Medicine Siriraj Hospital, Mahidol University, 3. Chiangrai Prachanukroh Hospital, Chiang Rai, 4. Sanpatong Hospital, Chiang Mai, and 5. HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok

You may qualify if:

  • age \< 18 years old
  • Have confirmed HIV infection (ELISA,HIV-DNA PCR,HIV-RNA PCR)
  • Signed consent form

You may not qualify if:

  • Hospitalization
  • Emergency case
  • Incomplete Medical Record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chiangrai Prachanukroh Hospital

Chiang Rai, Changwat Chiang Rai, Thailand

Location

Bamrasnaradura infectious disease institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Sanpatong Hospital

Sanpathong, Chiang Mai, Thailand

Location

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Related Publications (1)

  • Bunupuradah T, Sricharoenchai S, Hansudewechakul R, Klinbuayaem V, Teeraananchai S, Wittawatmongkol O, Akarathum N, Prasithsirikul W, Ananworanich J; Pediatric PROGRESS Study Team. Risk of first-line antiretroviral therapy failure in HIV-infected Thai children and adolescents. Pediatr Infect Dis J. 2015 Mar;34(3):e58-62. doi: 10.1097/INF.0000000000000584.

    PMID: 25478649RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Wisit Prasithsirikul, MD

    Bamrasnaradura infectious disease institute

    PRINCIPAL INVESTIGATOR

  • Rawiwan Hansudewechakul, MD

    Chiangrai Prachanukroh Hospital

    PRINCIPAL INVESTIGATOR

  • Wirat Klinbuayam, MD

    Sanpatong Hospital

    PRINCIPAL INVESTIGATOR

  • Jintanat Ananworanich, MD, PhD

    HIV-NAT, Thai Red Cross - AIDS Research Centre

    PRINCIPAL INVESTIGATOR

  • Kulkanya Chokephaibulkit, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

April 4, 2011

Study Start

January 1, 2009

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

TH(5)