Treatment Interruption in Children with Chronic HIV-Infection: the TICCH Trial - The TICCH trial

Phase 1

• Conditions: Infected with Human Immunodeficiancy Virus - (HIV-Infection)

• Registration Number: EUCTR2004-002050-66-IE
• Lead Sponsor: PENTA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

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

Inclusion Criteria

1. Aged 2-15 years inclusive.
2. Parents/guardians, and children where appropriate, willing and able to give informed consent .
3. Children currently on the same regimen of 3 or more antiretroviral drugs for at least 24 weeks.
4. Children and parents prepared to restart the same regimen after treatment interruption if CD4% falls to < 20% (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 RNA viral load <50 copies/ml (at least one month apart)
6. Most recent two CD4% > 30% with TLC >1000 (at least one month apart); most recent two CD4% should be stable (different by no more than 4%).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Cannot and unwilling to attend regularly
2. Unwilling to restart ART if CD4% 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the role of planned treatment interruptions (PTIs) in the management of HIV infected children who have responded well to antiretroviral therapy and to determine whether children undergoing a PTI are disadvantaged clinically, immunologically or virologically by having spent periods of time off antiretroviral therapy (ART).;Primary end point(s): CD4% < 15%<br>new CDC stage C diagnosis;Secondary Objective: 1. To assess HIV-specific immune responses during and after interruption of ART, compared with continuous ART, in an immunology and Virology substudy.<br><br>2. To assess the pharmacokinetics of agents with long half-lives - NNRTI and Lamivudine and their association with the development of resistance in the context of planned treatment interruptions.