Clinical trial NCT01225406: Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Thailand
name: National Health Security Office, Thailand
First posted: 2010-10-21
Enrollment: 56
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai children aged \< 18 years old who are on or are switching to third line antiretroviral therapy

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: undetectable viral load
timeFrame: 48 weeks
Secondary outcomes:
measure: Hyperlipidemia
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Bangkok
country: Thailand
facility: HIV-NAT
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
city: Chantaburi
country: Thailand
facility: Prapokklao Chantaburi
city: Chiang Mai
country: Thailand
facility: Nakornping Hospital
city: Chiang Rai
country: Thailand
facility: Chiang Rai Regional Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Institute
city: Surin
country: Thailand
facility: Surin Hospital
Study officials:
affiliation: Chulalongkorn University Bangkok
name: Thanyawee Puthanakit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siriraj Hospital, Mahidol University, Bangkok, Thailand.
name: Kulkanya Chokephaibulkit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.