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    Summary
    EudraCT Number:2006-002864-24
    Sponsor's Protocol Code Number:UMCN-AKF 06.02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-002864-24
    A.3Full title of the trial
    Drug interactions between ATOvaquone used in MAlaria prophylaxis and antiretroviral agents in HIV-1 infected patients (ATOMA)
    A.3.2Name or abbreviated title of the trial where available
    ATOMA
    A.4.1Sponsor's protocol code numberUMCN-AKF 06.02
    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 SponsorDept. of Clinical Pharmacy, Radboud UMC Nijmegen, The Netherlands
    B.1.3.4CountryNetherlands
    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 Yes
    D.2.1.1.1Trade name Malarone
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline
    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.3.4Pharmaceutical form 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 INNATOVAQUONE
    D.3.9.1CAS number 95233184
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGUANIL HYDROCHLORIDE
    D.3.9.1CAS number 637321
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.100
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeanti malarial agent with two agents (atovaquone and proguanil). Both are from chemical origin.
    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
    malaria prophylaxis in HIV patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10025494
    E.1.2Term Malaria prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of antiretroviral agents (low-dose ritonavir + lopinavir, low dose ritonavir + atazanavir, efavirenz) on the pharmacokinetics of single dose atovaquone determined by intersubject comparison.
    E.2.2Secondary objectives of the trial
    -To determine the effect of antiretroviral agents (low-dose ritonavir + lopinavir, low dose ritonavir + atazanavir, efavirenz) on the pharmacokinetics of single dose proguanil determined by intersubject comparison.

    -To evaluate the safety of combined use of single dose atovaquone/proguanil and lopinavir/ritonavir, atazanavir/ritonavir and efavirenz.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy volunteers:
    1.Subject is at least 18 and not older than 65 years of age on the day of dosing of atovaquone/proguanil.
    2.Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
    3.Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
    4.Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
    5.Subject is in good age-appropriate health condition as established by medical history, physical examination, results of biochemistry, haematol-ogy and urinalysis testing within 4 weeks prior to the first dose.Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A of study protocol). If not, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
    6.Subject has a normal blood pressure and pulse rate, according to the In-vestigator's judgement.

    HIV patients:
    1.HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
    2.CD4+ > 200 * 106 /L.
    3.Subject is at least 18 and not older than 65 years of age at the day of dosing of atovaquone/proguanil.
    4.Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
    5.Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
    6.Use of lopinavir/ritonavir, atazanavir/ritonavir or efavirenz for at least 1 month in a dose of 400/100mg bid, 300/100 mg QD, or 600 mg QD respectively.
    E.4Principal exclusion criteria
    Healthy volunteers:
    1.History of sensitivity/idiosyncrasy to atovaquone/proguanil or chemically related compounds or excipients.
    2.Positive HIV test.
    3.Positive HbsAg test (hepatitis B) or positive hepatitis C test.
    4.Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
    5.Creatinine clearance < 60 mL/min (calculated from serum creatinine).
    6.Current diarrhoea.
    7.Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
    8.History of or current abuse of drugs, alcohol or solvents.
    9.Inability to understand the nature and extent of the trial and the procedures required.
    10.Participation in a drug trial within 60 days prior to the first dose.
    11.Donation of blood within 60 days prior to the first dose.
    12.Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
    13.Abnormal serum transminases, determined as levels being > 3 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
    14.Febrile illness within 3 days before the first dose

    HIV infected patients:
    1.History of sensitivity/idiosyncrasy to atovaquone/proguanil or chemically related compounds or excipients.
    2.Suspicion of non-adherence to the HIV medication.
    3.Current diarrhoea.
    4.Relevant history or current condition that might interfere with drug absorp-tion, distribution, metabolism or excretion.
    5.Inability to understand the nature and extent of the trial and the procedures required.
    6.Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
    7.Abnormal serum transminases determined as levels being > 3 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
    8.Creatinine clearance < 60 mL/min (calculated from serum creatinine).
    9.Any change in antiretroviral medication within 1 month immediately preceding the dose of atovaquone/proguanil.
    10.Concomitant use of medications that interfere with atovaquone or proguanil pharmacokinetics: anti-coagulants, aurothioglucose, chloroquine, cimetidine, fluoxetine, fluvoxamine, metoclopramide, omeprazole, magnesiumtrisilicate, rifabutin, rifampin, tetracycline, thyphoid vaccine, topiramate.
    11.Use of a HAART regime containing both lopinavir/ritonavir and an other protease inhibitor or an NNRTI.
    12.Use of a HAART regime containing both atazanavir/ritonavir and an other protease inhibitor or an NNRTI.
    13.Use of a HAART regime containing both efavirenz and one or more prote-ase inhibitors or nevirapine.
    14.Active hepatobiliary or hepatic disease
    15.Alcohol abuse
    E.5 End points
    E.5.1Primary end point(s)
    The effect of lopinavir/ritonavir, atazanavir/ritonavir and efavirenz on atovaquone pharmacokinetics (AUC, Cmax).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    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
    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 years1
    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 years1
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 2006-06-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2006-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-17
    P. End of Trial
    P.End of Trial StatusCompleted
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