Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children

NCT01225406 | Completed

• 1 other identifier: HIV-NAT 113
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 9

Brief Summary

This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.

Conditions

This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy

Keywords

Third line ARV therapy; HIV RNA; Absolute CD4+ T cell count; serious adverse events (SAEs); Drug resistance

Outcome Measures

Primary Outcomes (1)

• undetectable viral load

  Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.

  48 weeks

Secondary Outcomes (1)

• Hyperlipidemia

  48 weeks

Study Arms (2)

third line naive

Children on second line or other regimen who switch or start third line regimen

Drug: Tenofovir

third line experienced

children who are on third line regimen

Drug: Tenofovir

Interventions

Tenofovir DRUG

third line experienced; third line naive

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Thai children aged \< 18 years old who are on or are switching to third line antiretroviral therapy

You may qualify if:

• Children (\< 18 years old) with HIV infection may enroll if one of the following criteria is met:
• Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA \> 1000 copies/ml prior to switching to third line ARV therapy
• Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir

You may not qualify if:

• Have hepatic impairment with ALT ≥ 5 upper limit of normal
• Pregnant or breastfeeding

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Ministry of Education, Thailand: collaborator
• National Health Security Office, Thailand: collaborator

Study Sites (9)

Prapokklao Chantaburi

Chanthaburi, Changwat Chanthaburi, 22000, Thailand

Location

Chulalongkorn University

Bangkok, 10330, Thailand

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Nakornping Hospital

Chiang Mai, 50180, Thailand

Location

Chiang Rai Regional Hospital

Chiang Rai, 57000, Thailand

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, 11000, Thailand

Location

Surin Hospital

Surin, 32000, Thailand

Location

Related Publications (1)

• Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged >/=7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6.

  PMID: 22954687 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and PBMC

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thanyawee Puthanakit, MD

  Chulalongkorn University Bangkok

  PRINCIPAL INVESTIGATOR

• Kulkanya Chokephaibulkit, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 21, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (9)