NCT02406768

Brief Summary

To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
2 countries

10 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

October 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

March 31, 2014

Last Update Submit

March 30, 2015

Conditions

Neurocognitive Development

Keywords

normal controls

Outcome Measures

Primary Outcomes (1)

  • neurodevelopment changes (composite of cognitive, fine motor and behavioral)

    measured by cognitive test, fine motor test and behavioral assessment test

    up to 96 weeks

Study Arms (2)

HIV negative unexposed

HIV negative controls

HIV negative exposed

HIV-negative children born to HIV-infected mothers

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

HIV negative unexposed and HIV-negative children born to HIV-infected mothers

You may qualify if:

  • Child from a HIV-positive mother
  • Documented negative test for HIV-1 infection
  • Between the age from 1-15 years
  • Caregiver of the subject is willing and able to sign informed consent, prior to the study
  • Thai or Cambodian origin
  • HIV negative and not HIV exposed:
  • Child from a HIV-negative mother (by history)
  • Documented negative test for HIV-1 infection
  • Between the age from 1-15 years
  • Caregiver of the subject is willing and able to sign informed consent, prior to the study
  • Thai or Cambodian origin

You may not qualify if:

  • The inability of the caregivers to understand the nature and extend of the trial and the procedure required
  • Patients with psychiatric disorder
  • Patients with a syndrome that affects cognitive performance
  • for HIV negative and not HIV exposed
  • The inability of the caregivers to understand the nature and extent of the trial and the procedure required
  • Patients with psychiatric disorder
  • Patients with a syndrome that affects cognitive performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

National Center for HIV/AIDS, Dermatology and STDs (NCHADS)

Phnom Penh, Cambodia

Location

National Pediatric Hospital

Phnom Penh, Cambodia

Location

Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center

Bangkok, Bangkok, 10330, Thailand

Location

Prapokklao Hospital

Chanthaburi, Changwat Chanthaburi, 22000, Thailand

Location

Chiangrai Regional Hospital

Chiang Rai, Changwat Chiang Rai, 57000, Thailand

Location

Queen Savang Vadhana Memorial Hospital, Pediatric Department,

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Department of Pediatrics Faculty of Medicine Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Nakornping Hospital

Chiang Mai, Chiang Mai, 50180, Thailand

Location

Related Publications (1)

  • Puthanakit T, Ananworanich J, Vonthanak S, Kosalaraksa P, Hansudewechakul R, van der Lugt J, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vibol U, Pruksakaew K, Suwarnlerk T, Apornpong T, Ratanadilok K, Paul R, Mofenson LM, Fox L, Valcour V, Brouwers P, Ruxrungtham K; PREDICT Study Group. Cognitive function and neurodevelopmental outcomes in HIV-infected Children older than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study. Pediatr Infect Dis J. 2013 May;32(5):501-8. doi: 10.1097/INF.0b013e31827fb19d.

    PMID: 23263176RESULT

Related Links

Study Officials

  • Kiat Ruxrungtham, MD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 2, 2015

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

TH(8)CA(2)