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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-003827-10
    Sponsor's Protocol Code Number:APV102002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-10
    Trial results View 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-003827-10
    A.3Full title of the trial
    A Phase III, Randomized, Controlled, Open-label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-boosted HIV-1 Protease Inhibitor (PI) regimen of Fosamprenavir (FPV)/ Lopinavir (LPV)/Ritonavir (RTV)/1400mg/533mg/133mg Twice Daily (BID) and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-infected Adults Experiencing Virological Failure
    A.4.1Sponsor's protocol code numberAPV102002
    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 SponsorGlaxoSmithKline R&D
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 TELZIR
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTelzir
    D.3.2Product code GW433908
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfosamprenavir
    D.3.9.2Current sponsor codeGW433908
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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
    Treatment of heavily pretreated patients
    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 test the superiority of the increased FPV dose (FPV/RTV 1400mg/100mg BID; Group B) and the dual boosted PI combination FPV/LPV/RTV (700mg/533mg/133mg BID) based therapy (Group C) over the standard FPV/RTV (700mg/100mg BID) based therapy (Group A) as measured by the average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
    E.2.2Secondary objectives of the trial
    To compare the antiviral response of the increased FPV dose (Group B) and FPV/LPV/RTV based therapy (Group C) versus the standard FPV/RTV based therapy (Group A) over 24 weeks of therapy;
    To compare the safety and tolerability of Group B and Group C versus Group A over 24 weeks of therapy;
    To compare the occurrence of events related to metabolic abnormalities of Group B and Group C versus Group A over 24 weeks of therapy;
    To compare the immunologic response of Group B and Group C versus Group A over 24 weeks of therapy;
    To characterise steady-state plasma APV trough concentrations and, where applicable, LPV trough concentrations;
    To evaluate the impact of absolute values in GIQ on virological outcome at Week 24;
    To assess viral resistance patterns at baseline and those which emerge in subjects with virological failure, and to correlate these patterns with treatment outcome.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Adult male and female PI-experienced HIV-infected subjects ≥18 years.
    2. Three antiretroviral class (N(t)RTI, NNRTI and PI) therapy experienced subjects
    3. ≥2 prior PI-based regimen with a documented history of virological failure (a confirmed plasma HIV-1 RNA concentration of  400 copies/mL)
    4. Documented evidence of a viral genotype with at least one primary protease mutation other than the D30N.
    5. HIV-1 RNA assay ≥1000 copies/mL at screening
    6. No antiretroviral therapy (ART) modifications between Screening and Day 1.
    7. A female subject is eligible to enter and participate in the study if she is of:
    a Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal);
    b Childbearing potential, has a negative serum beta human chorionic gonadotropin (beta-HCG, pregnancy) test at screen and negative urine pregnancy test at Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician):
     Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products or permitted substitution medications, throughout the study, and for at least 2 weeks after discontinuation of all investigational products or permitted substitution medications;
     Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
     Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year;
     Sterilization (female subject or male partner of female subject).
    Hormonal contraception is not acceptable for inclusion into this study.
    All subjects participating in this study should be counselled on the practice of safe sex.
    8. The subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
    9. Subject or subject’s legal representative is willing and able to understand and provide written informed consent prior to participation in this study
    E.4Principal exclusion criteria
    1. Subjects with virus harboring the I50V mutation, the V32I with I47V mutations or six or more of the following PRO mutations in the screening genotype (APV/RTV resistance algorithm):
    L10F/I/V, K20M/R, E35D, R41K, I54V, L63P, V82A/F/T/S or I84V
    2. Subjects with virus harboring eight or more of the following PRO mutations in the screening genotype (LPV/RTV mutation score [Kempf et al., 2001]):
    L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V, or L90M
    3. Known non-adherence as key cause for detectable viral load
    4. Planned use of NNRTIs as part of the study salvage regimen
    5. Planned use of atazanavir or hydroxyurea as part of the study salvage regimen
    6. Evidence of current active hepatitis or any clinically relevant hepatitis within 28 days prior to entry.
    7. History of clinically relevant pancreatitis or any clinically relevant hepatitis within the last 6 months.
    8. If, in the opinion of the examining physician, an unstable hepatic, cardiovascular, renal, pulmonary, endocrine, metabolic, neurological, haematological, or gastrointestinal condition is present or any other medical condition which the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial or constitutes an unacceptable risk to the subject.
    9. Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the subject’s participation in the study of an investigational compound.
    10. Any grade 4 laboratory abnormality would exclude a subject from study participation
    11. Subject has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.
    12. Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression
    13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) within 28 days prior to Day 1.
    14. Total bilirubin >2.5 times ULN within 28 days prior to Day 1.
    15. Subject has an estimated creatinine clearance <60 mL/min via the Cockcroft-Gault method. NOTE: Creatinine clearance should be estimated using the following formula:
    - For serum creatinine concentration in mg/dL:
    - ((140-age)(weight in kg)/ serum creatine x 72 ) x (0.85 for women only)
    - For serum creatinine concentration in µmol/L:
    - ((140-age)(weight in kg) / serum creatine x 0.8) x (0.85 for women only)
    16. Subjects who require treatment with any of the following medications within 28 days of commencement of investigational product, or an anticipated need during the study:
     Amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, triazolam (these drugs have been excluded due to potential drug interactions with either FPV, LPV and/or RTV leading to safety problems)
     Carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, St Johns Wort (Hypericum perforatum), troglitazone (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations).
     Investigators should consult the most current prescribing information for each Investigational product for medications that are "Contraindicated" as well as Section 8.2 "Prohibited Medications"
    17. Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.
    18. Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to Screen.
    19. Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which may interfere with drug absorption or render the subject unable to take oral medication.
    20. Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject’s ability to comply with the dosing schedule and protocol evaluations and assessments.
    21. Subject is, in the opinion of the investigator, unable to complete the 24-week dosing period and protocol evaluations and assessments
    22. Subject is either pregnant or breastfeeding.
    23. Female subjects who are lactating.
    24. Subject has a history of allergy to any of the investigational products or any excipients therein.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the average area under the curve minus baseline (AAUCMB) in log10 plasma HIV-1 RNA at Week 24.
    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) No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2005-02-10. 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 150
    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 Decision2005-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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