Clinical Trials Nct Page

Summary
EudraCT Number:2004-002633-39
Sponsor's Protocol Code Number:SHCS-Projekt Nr. 408
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2004-12-13
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 ConcernedGermany - BfArM
A.2EudraCT number2004-002633-39
A.3Full title of the trial
Prospective study of switch to 3TC monotherapy with evaluation of replication capacity in patients with virologic failure and 3TC resistance
(a multicenter prospective clinical study within the SHCS) SHCS-Projekt Nr. 408
A.3.2Name or abbreviated title of the trial where available
3TC Mono Study
A.4.1Sponsor's protocol code numberSHCS-Projekt Nr. 408
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 SponsorProf. Dr. med. Milos Opravil, Universitätsspital Zürich
B.1.3.4CountrySwitzerland
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 RoleTest
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 Epivir
D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd.
D.2.1.2Country which granted the Marketing AuthorisationGermany
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 nameEpivir
D.3.2Product code 3TC
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
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 No
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
HIV patients with virological treatment failure due to multi-drug-resistant virus including 3TC resistance
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 whether in patients with virologic failure due to multi-drug resistant virus including 3TC resistance, maintenance of CD4 lymphocytes within a level that implies no severe immune deficiency may be achievable with 3TC monotherapy. This would be of particular benefit for patients who suffer from adverse events of their current ART. With 3TC monotherapy, future treatment options with other drugs and drug classes will be preserved and adverse events associated with a new salvage therapy avoided.
The study endpoints will be:
- Time to CD4 decrease by 30% or below 200 cells/µl
- Number of patients who will need to re-start HAART again within 12 months
- Adverse events associated with 3TC monotherapy
E.2.2Secondary objectives of the trial
At study end, we will evaluate whether the study endpoints correlate with any of the following:
- highly impaired RC (<30%) vs. less impaired or normal RC (>30%) at baseline
- CD4 lymphocyte levels at baseline and as nadir
- HIV RNA set point prior to ART (if available)
- HIV RNA at baseline and during the study
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
Documented HIV-1 infection with clade B virus.
•Patients undergoing resistance testing because of virologic failure, defined as two consecutive HIV RNA values >400 copies/ml with the second one >1000 copies/ml.
•Currently on (for at least 3 months) stable HAART (3 or more antiretroviral drugs).
•CD4 >300/µl and no active opportunistic infection.
•HIV RNA 1000 – 100'000 copies/ml.
•Presence of the 184V or 184I RT mutation, or 3TC phenotypic resistance.
•Additional resistance, defined as either genotypic mutations to at least one additional major NRTI (K65R; 69 insertion; T69D,N; L74I,V; V75A,T; Q151L,M; T215F,Y) and at least one major PI (D30N; G48V; I50N; V82A,F,S,T; I84V,A; L90M) mutation; or as a phenotypic resistance to at least one additional NRTI and one protease inhibitor.
•Written informed consent.
E.4Principal exclusion criteria
Prior documented intolerance of 3TC.
•Patients participating in other clinical trials.
•Patients receiving immunomodulators or undergoing structured treatment interruptions.
E.5 End points
E.5.1Primary end point(s)
CD4 from baseline (average week –2 and 0) to week 24 and 48.
Secondary endpoints: Time course of RC, genotypic and phenotypic resistance, HIV RNA, p24 antigen, RT activity, adverse events, and clinical course.
Secondary endpoints: Time course of RC, genotypic and phenotypic resistance, HIV RNA, p24 antigen, RT activity, adverse events, and clinical course.
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 Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
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 No
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) Information not present in EudraCT
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
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
Individual end of trial: week 48
End of trial: last visit of the last subject undergoing the trial

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 months
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 No
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) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
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 2004-12-13. 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 No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state5
F.4.2 For a multinational trial
F.4.2.1In the EEA 5
F.4.2.2In the whole clinical trial 30
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 Decision2004-12-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-02-17
P. End of Trial
P.End of Trial StatusOngoing

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