NCT01002612

Brief Summary

To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

November 9, 2009

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

October 23, 2009

Last Update Submit

November 6, 2009

Conditions

HIV InfectionHIV Infections

Keywords

Nutritional statusThai HIV-infected children

Outcome Measures

Primary Outcomes (1)

  • Growth parameters (weight and height), blood lipid levels and dietary intakes

    6 months

Secondary Outcomes (1)

  • Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children

    6 months

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Thai HIV-infected children living in a family style community located in rural central region of Thailand

You may qualify if:

  • Children age 4-15 years old
  • Confirmed HIV-1 diagnosis
  • Reside at the community
  • The guardian must be able and willing to provide written informed consent. Oral consent in the presence of witness is acceptable in the case of illiteracy

You may not qualify if:

  • non-HIV infected children
  • Age 0-3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Praphan Phanuphak, MD

    The Thai Red Cross AIDS Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 27, 2009

Study Start

December 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 9, 2009

Record last verified: 2009-10

Locations

TH(1)