Treatment Interruption in Children with Chronic Human immunodeficiency virus infection: the TICCH Trial
| ISRCTN | ISRCTN36694210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36694210 |
| Secondary identifying numbers | PENTA 11 |
- Submission date
- 09/01/2004
- Registration date
- 25/02/2004
- Last edited
- 06/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=25
Contact information
Dr Carlo Giaquinto
Scientific
Scientific
Dipartimento di Pediatria
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy
| Phone | +39 (0)49 821 3563 |
|---|---|
| carlog@pediatria.unipd.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Sample information sheets can be found in the full protocol at: http://www.pentatrials.org/p11v4100907.pdf |
| Scientific title | Treatment Interruption in Children with Chronic Human immunodeficiency virus infection: the TICCH Trial |
| Study acronym | TICCH |
| Study objectives | The overall aim of the PENTA 11 trial is to evaluate the role of planned treatment interruptions in the management of Human Immunodeficiency Virus (HIV) infected children who have responded well to Anti-Retroviral Therapy (ART). The specific objectives are: 1. To determine whether children with chronic HIV infection undergoing planned ART treatment interruptions are disadvantaged clinically, immunologically or virologically by periods of time off ART. 2. To assess HIV-specific immune responses during and after interruptions of ART, compared with continuous ART, in an immunology/virology substudy. |
| Ethics approval(s) | Added as of 24/09/2007: Favourable ethics approval by Trent Multi-Centre Research Ethics Committee on 14/06/2004. |
| Health condition(s) or problem(s) studied | Paediatric Human Immunodeficiency Virus (HIV) |
| Intervention | Status of trial as of 24/09/2007: Closed to recruitment. In follow-up. Randomised controlled trial of planned treatment interruptions in children who are taking antiretoviral therapy for HIV infection. Randomised to one of two arms: continue therapy or CD4 driven planned treatment interruptions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Anti-Retroviral Therapy (ART) |
| Primary outcome measure | Primary outcome measures amended as of 24/09/2007: CD4% less than 15% and/or new Centers for Disease Control and Prevention (CDC) stage C diagnosis: 1. CD4% less than 15% (age 2-6 years) 2. CD4% less than 15% and CD4 <200 cells/mm3 (age >7 years) 3. New CDC stage C diagnosis 4. Death Primary outcome measures provided at time of registration: CD4% less than 15% and/or new CDC (Centers for Disease Control and Prevention) stage C diagnosis. |
| Secondary outcome measures | 1. Change in ART (defined as any change from the ART regimen at randomisation) 2. Acute retroviral syndrome 3. ART-related grade three and four clinical and laboratory adverse events 4. HIV-1 RNA equals 400 copies/ml at week 72 having received ART continuously for the preceding 12 weeks 5. HIV-1 RNA equals 50 copies/ml at week 72 having received ART continuously for the preceding 12 weeks 6. Number of HIV mutations present at 72 weeks conferring resistance to drugs taken at entry or during the trial 7. Adherence to ART as assessed by caregiver completed questionnaire 8. Acceptability of the two strategies of ART administration to paediatricians and families |
| Overall study start date | 01/11/2004 |
| Completion date | 18/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 100 (110 recruited) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 18/06/2008 |
Locations
Countries of recruitment
- France
- Germany
- Ireland
- Italy
- Spain
- Switzerland
- Thailand
- United Kingdom
- United States of America
Study participating centre
Dipartimento di Pediatria
Padova
35128
Italy
35128
Italy
Sponsor information
The Paediatric European Network for the Treatment of AIDS (PENTA) Foundation (Italy)
Other
Other
Dipartimento di Pediatria
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy
| Phone | +39 (0)49 821 3563 |
|---|---|
| carlog@pediatria.unipd.it | |
| Website | http://www.pentatrials.org.uk |
"ROR" |
https://ror.org/03ash3475 |
Funders
Funder type
Government
European Union funding (ref: QLK2-2000-00150)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/05/2008 | Yes | No | |
| Results article | results | 16/01/2010 | Yes | No | |
| Results article | results | 20/02/2013 | Yes | No | |
| Results article | Follow up study | 29/07/2021 | 06/09/2021 | Yes | No |
Editorial Notes
06/09/2021: Publication reference added.
