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

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration (Other)

Overall Status

Completed

CT.gov ID

NCT01225406

Collaborator

Ministry of Education, Thailand (Other), National Health Security Office, Thailand (Other)

Enrollment

Locations

Duration (Months)

6.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy	Drug: Tenofovir

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

Study Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Cohort

Time Perspective:

Other

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 Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Hyperlipidemia [48 weeks]
Number of subjects with hyperlipidemia as a measure of safety

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chulalongkorn University	Bangkok	Thailand	10330
2	HIV-NAT	Bangkok	Thailand	10330
3	Siriraj Hospital, Mahidol University	Bangkok	Thailand	10700
4	Prapokklao Chantaburi	Chantaburi	Thailand	22000
5	Nakornping Hospital	Chiang Mai	Thailand	50180
6	Chiang Rai Regional Hospital	Chiang Rai	Thailand	57000
7	Khon Kaen University	Khon Kaen	Thailand	40002
8	Bamrasnaradura Institute	Nonthaburi	Thailand	11000
9	Surin Hospital	Surin	Thailand	32000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Thanyawee Puthanakit, MD, Chulalongkorn University Bangkok
Principal Investigator: Kulkanya Chokephaibulkit, MD, Siriraj Hospital, Mahidol University, Bangkok, Thailand.