Clinical Trial Page

Summary
EudraCT Number:2004-002050-66
Sponsor's Protocol Code Number:PENTA 11
National Competent Authority:Ireland - HPRA
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2004-09-14
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedIreland - HPRA
A.2EudraCT number2004-002050-66
A.3Full title of the trial
Treatment Interruption in Children with Chronic HIV-Infection: the TICCH Trial
A.3.2Name or abbreviated title of the trial where available
The TICCH trial
A.4.1Sponsor's protocol code numberPENTA 11
A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number36694210
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorPENTA Foundation
B.1.3.4CountryItaly
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Strategy trial therefore this section is NOT APPLICABLE. All products that are to be used in the trial are alreay licensed. Please find enclosed a copy of the DDX.
D.2.1.1.2Name of the Marketing Authorisation holderDr Gibb
D.2.1.2Country which granted the Marketing AuthorisationIreland
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameN/A
D.3.2Product code N/A
D.3.4Pharmaceutical form
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 2
D.1.2 and D.1.3IMP Role
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Strategy trial therefore this section is NOT APPLICABLE. All products that are to be used in the trial are alreay licensed. Please find enclosed a copy of the DDX.
D.2.1.1.2Name of the Marketing Authorisation holderDr Gibb
D.2.1.2Country which granted the Marketing AuthorisationIreland
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameN/A
D.3.4Pharmaceutical form
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Infected with Human Immunodeficiancy Virus - (HIV-Infection)
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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).
E.2.2Secondary objectives of the trial
1. To assess HIV-specific immune responses during and after interruption of ART, compared with continuous ART, in an immunology and Virology substudy.

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.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal 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%).
E.4Principal 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
E.5 End points
E.5.1Primary end point(s)
CD4% < 15%
new CDC stage C diagnosis
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy No
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Yes
E.6.13.1Other scope of the trial description
Management Trial
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Continuous therapy vs. planned treatment interruptions
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
It is planned to recruit 100 children over 12 months. All children will be followed until the last child enrolled has completed 72 weeks follow-up.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months6
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) Yes
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-09-14. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Incapable of giving consent because they are minors - in which case consent will be obtained from parents and legal guardians.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 85
F.4.2.2In the whole clinical trial 100
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
No difference from expected normal treatmemnt.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-09-30
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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