Treatment Interruption in Children with Chronic Human immunodeficiency virus infection: the TICCH Trial

Not Applicable

Completed

• Conditions: Paediatric Human Immunodeficiency Virus (HIV); Infections and Infestations

• Registration Number: ISRCTN36694210
• Lead Sponsor: The Paediatric European Network for the Treatment of AIDS (PENTA) Foundation (Italy)

Brief Summary

2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18419497 results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20010073 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23135172 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34475868/ Follow up study (added 06/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-02-25
• Study Completion: 2008-06-18
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria amended as of 24/09/2007:
1. Aged 2 to 15 years inclusive
2. Parents/guardians, and children where appropriate, willing and able to give informed consent
3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks
4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls to <20% (children aged 2-6 years) or CD4% falls to <20% or CD4 count falls to <350 cells/mm3 (children aged >7 years) (confirmed on a second sample) or after 48 weeks on a PTI
5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart)
6. Most recent two CD4% >30% (children aged 2-6 years) or most recent two CD4% >25% and CD4 count >500 cells/mm3 (children aged >7 years); most recent two CD4% should be stable (different by no more than 4%)
7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart)
8. Willing to attend 4 weekly monitoring visits if CD4 declines to <400 cells/mm3 or CD4% <22%

Inclusion criteria provided at time of registration:
1. Aged 2 to 15 years inclusive
2. Parents/guardians, and children where appropriate, willing and able to give informed consent
3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks
4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls below 20% (aged two to six years) or CD4% falls to less than 20% and CD4 count falls to less than 350 cells/mm^3 (confirmed on a second sample). Children and parents prepared to continue on current therapy until clinical or virological failure if randomised to the continuous therapy arm
5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart)
6. Most recent two CD4% equal 30% (children aged two to six years) or most recent two CD4% equals 25% and CD4 count is more than 350 cells/mm^3. Most recent two CD4% should be stable (different by no more than 4%)
7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart)

Exclusion Criteria

Exclusion criteria amended as of 24/09/2007:
1. Cannot or unwilling to attend regularly
2. Unwilling to restart ART if CD4 percent or count indicates this is necessary
3. Intercurrent illness (randomisation can take place after the illness)
4. Pregnancy or risk of pregnancy in girls of child-bearing potential
5. Previous symptomatic thrombocytopaenia with platelets <50 x 10 (to the power of 9)/l
6. Positive for hepatitis B surface antigen and receiving either lamivudine or tenofavir

Exclusion criteria provided at time of registration:
1. Cannot or unwilling to attend regularly
2. Unwilling to restart ART if CD4 percent or count indicates this is necessary
3. Intercurrent illness (randomisation can take place after the illness)
4. Pregnancy or risk of pregnancy in girls of child-bearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified