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

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

Official title:

Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225406
• Other study ID #: HIV-NAT 113
• Status: Completed
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.

Third line ARV therapy is defined as an 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:

1. 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

2. Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir

Exclusion Criteria:

1. Have hepatic impairment with ALT = 5 upper limit of normal

2. Pregnant or breastfeeding

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tenofovir

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok
Thailand	HIV-NAT	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok
Thailand	Prapokklao Chantaburi	Chantaburi
Thailand	Nakornping Hospital	Chiang Mai
Thailand	Chiang Rai Regional Hospital	Chiang Rai
Thailand	Khon Kaen University	Khon Kaen
Thailand	Bamrasnaradura Institute	Nonthaburi
Thailand	Surin Hospital	Surin

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Ministry of Education, Thailand, National Health Security Office, Thailand

Country where clinical trial is conducted

Thailand, 

References & 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 da — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hyperlipidemia	Number of subjects with hyperlipidemia as a measure of safety	48 weeks

External Links

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