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    Summary
    EudraCT Number:2007-000950-30
    Sponsor's Protocol Code Number:HPH116-104-PoC-2007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-06-04
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2007-000950-30
    A.3Full title of the trial
    Estudio piloto, doble ciego, aleatorizado, controlado con placebo, de dosis repetida, para la evaluación de la seguridad y la eficacia antiviral de HPH116 en pacientes infectados por VIH-1 que no hayan recibido tratamiento previo

    A pilot, double-blinded, randomized, placebo-controlled, repeated dose, assessing HPH116 antiviral safety and efficacy in naïve HIV-1 infected patients.
    A.3.2Name or abbreviated title of the trial where available
    PoC
    A.4.1Sponsor's protocol code numberHPH116-104-PoC-2007
    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 SponsorH-PHAR,sa
    B.1.3.4CountryBelgium
    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 No
    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 nameazodicarbonamide
    D.3.2Product code HPH116
    D.3.4Pharmaceutical form Capsule*
    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.3.9.1CAS number 123-77-3
    D.3.9.2Current sponsor codeHPH116
    D.3.9.3Other descriptive nameazodicarbonamide/HPH116 (formely ADA)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberphase 1 : 600mg to phase2 : 1.200 mg
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad medica investigada = SIDA (pacientes infectados con VIH-1)
    Pacientes infectados por VIH-1 que no hayan recibido tratamiento previo recibirán 600 mg ó 1200 mg de HPH116 dos veces al día frente a placebo equivalente durante 28 días. Los objetivos son la evaluación de la seguridad y la eficacia (primeros resultados preliminares) de HPHP116 en la población de estudio.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020180
    E.1.2Term HIV positive
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the safety and tolerability of the drug in HIV-1 infected patients.
    E.2.2Secondary objectives of the trial
    Secondary endpoint:
    - Viral load reduction
    - CD4+ increase
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Pacientes que hayan firmado voluntariamente el Consentimiento informado aprobado por el Comité de Ética tras la explicación de la naturaleza y el objetivo del estudio, antes de efectuar cualquier procedimiento específico:
    - Las pacientes en edad fértil son idóneas para participar en el estudio si utilizan un método anticonceptivo aceptado médicamente. La paciente debe comprender las consecuencias y riesgos que puede tener la actividad sexual sin la debida protección, recibir formación y entender el uso correcto del método anticonceptivo (estar informada de los datos limitados de toxicidad para el embrión humano) y comprometerse a informar al investigador de cualquier posible cambio en su estado.
    - Las pacientes en edad fértil deben hacerse una prueba de embarazo en la orina.
    - Preferiblemente, las mujeres deben ser posmenopáusicas o utilizar otro método anticonceptivo o estar esterilizadas:

    • Carga viral de base ≥ 5.000 copias/ml.
    • CD4+ ≥ 200 células/µl, como mínimo;
    • Pacientes de 18 a 64 años con infección por VIH documentada.
    • Los pacientes incluidos en el estudio no han recibido estrictamente TAR previa.
    • No necesitan otra TAR aparte de HPH116 durante el periodo del estudio.
    E.4Principal exclusion criteria
    • Antecedentes o sospecha de antecedentes de alcoholismo o adicción a las drogas ilícitas activa.
    • Embarazo o mujeres lactantes.
    • Medicación concomitante diferente de la destinada a la profilaxis de las infecciones oportunistas.
    • N-acetilcisteína como suplemento alimentario o fármacos.
    • Sujetos con un historial de alergia farmacológica significativa.
    • Sujetos con un historial de enfermedad gastrointestinal significativa.
    • Sujetos con antecedentes de escaso cumplimiento con el calendario de visitas o la ingesta del medicamento.
    • Infección oportunista activa o neoplasia maligna con una esperanza de vida < 6 meses.
    • Fiebre de causa desconocida > 38,5ºC durante 7 días consecutivos.
    • Disfunción cardiaca significativa.
    • Insuficiencia renal: creatinina sérica > 1,5 X LSN.
    • Amilasa pancreática, lipasa > 1,3 X LSN.
    • Hemoglobina < 9,6 g/dl.
    • Recuento plaquetario < 75.109 c/l.
    • Recuento absoluto de neutrófilos < 1.000/mm3.
    • SGOT, SGPT o γGT > 2,5 X LSN.
    • Cualquier otro cuadro clínico que, según el criterio del investigador, pudiera comprometer el cumplimiento con el estudio o la posibilidad de evaluación de la seguridad y la eficacia
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    Haematology, biochemistry and urinalysis, vital signs and Adverse Events.
    HPH116 surrogate marker dosage:
    Urine analysis will be performed day 1, 3, 7, 14, 21 and 28 to evaluate HPH116 concentration associated with the VL load reduction. Urine analysis allows determining patient compliance.
    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 Yes
    E.6.10Pharmacogenetic No
    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 Yes
    E.7.1.3.1Other trial type description
    IIa proof of concept
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned6
    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 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 Yes
    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
    End of study = phone contact with the patient one week after the last dose intake
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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 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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    After end of trial, subject will receive standard care.
    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 Decision2007-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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