NCT00477308

Brief Summary

In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

3 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, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

3.2 years

First QC Date

May 20, 2007

Last Update Submit

July 15, 2020

Conditions

HIV Infections

Keywords

HIV childrengenotypic resistancedual NRTIsSalvage therapytreatment outcomeSalvage therapy based on genotyping resultsTreatment Failure

Outcome Measures

Primary Outcomes (1)

  • Clinical, immunologic and virologic outcome of children who had genotyping directed salvage therapy

    1 time point (Cross Sectional Study)

Secondary Outcomes (3)

  • Comparison outcome of children in the 3 groups,

    1 time point

  • Changes of mutation in children within the 3 groups, and

    1 time point

  • Effect of previously unreported mutations, minor and others, on treatment outcome

    1 time point

Study Arms (1)

salvage therapy

OTHER

Children with drug resistance were treated using the drug resistant profile

Procedure: salvage therapy

Interventions

salvage therapyPROCEDURE
salvage therapy

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All children from HIV-NAT 013 phase I

You may not qualify if:

  • No inform consent obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Queen Sirikit National Institute of Child Health, Bangkok

Bangkok, 10330, Thailand

Location

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Bunupuradah T, Suntarattiwong P, Li A, Sirivichayakul S, Pancharoen C, Boonrak P, Puthanakit T, Kerr SJ, Ruxrungtham K, Chotpitayasunondh T, Hirschel B, Ananworanich J; HIV-NAT 013 Study Team. Antiretroviral treatment outcome following genotyping in Thai children who failed dual nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2010 Apr;14(4):e311-6. doi: 10.1016/j.ijid.2009.05.017. Epub 2009 Aug 21.

    PMID: 19699673RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kiat Ruxrungtham, MD

    The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

    PRINCIPAL INVESTIGATOR

  • Tawee Chotpitayasunondh, MD

    Queen Sirikit National Institute of Child Health, Bangkok

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: salvage therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 23, 2007

Study Start

January 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(3)