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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2007-005769-36
    Sponsor's Protocol Code Number:GS-EU-177-0111
    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:2008-03-19
    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 number2007-005769-36
    A.3Full title of the trial
    A Phase IV, Open-label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV-1 infected Subjects Switching to Atripla (efavirenz/emtricitabine/tenofovir DF) on an Empty Stomach
    A.3.2Name or abbreviated title of the trial where available
    ONCE - Only Nocturnal Combination Evaluation
    A.4.1Sponsor's protocol code numberGS-EU-177-0111
    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 SponsorGilead Sciences Limited
    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 Yes
    D.2.1.1.1Trade name Atripla
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameefavirenz/emtricitabine/tenofovir disoproxil fumarate
    D.3.2Product code ATR
    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 INNefavirenz
    D.3.9.1CAS number 154598-52-4
    D.3.9.2Current sponsor codeEFV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNemtricitabine
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeFTC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenofovir disoproxil fumarate
    D.3.9.1CAS number 52232-67-4
    D.3.9.2Current sponsor codeTDF
    D.3.9.3Other descriptive nametenofovir DF
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 typeAntiretroviral agent
    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
    Antiretroviral-experienced HIV 1 infected subjects on their first and stable HAART regimen of efavirenz, emtricitabine, and tenofovir DF.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    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 pure virological response rates (defined as subjects who do not have pure virologic failure at HIV-1 RNA threshold of 50 copies/mL) in antiretroviral-experienced subjects receiving Atripla for 48 weeks on an empty stomach.
    E.2.2Secondary objectives of the trial
    •To assess how closely dosing recommendations are adhered to through the use of a subject-reported questionnaire
    •To assess change in absolute CD4 cell count
    •To describe the safety and tolerability through the reporting of adverse events and laboratory abnormalities
    •To evaluate acceptability by using three subject-reported questionnaires, HAART
    Intrusiveness Scale (m-HIS), Perceived Ease of Regimen for Condition (PERC), and
    Preference of Medicine (POM) questionnaires, through 48 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects must have documented HIV-1 infection by Roche Amplicor® (Version 1.5
    Ultra-sensitive) or equivalent assay – either at screening or previously documented in the patient’s medical record.
    • Stable HAART regimen of efavirenz, emtricitabine and tenofovir DF or Truvada and
    efavirenz for ≥ 24 weeks prior to Screening. (Subjects can have been previously treated with tenofovir DF, lamivudine, and efavirenz or tenofovir DF, emtricitabine, and efavirenz prior to switching to Truvada and efavirenz. They must have switched in order to simplify his/her HAART regimen and must not have had a treatment interruption prior to the switch).
    •Undetectable plasma HIV-1 RNA (< 50 copies/mL) at Screening and ≥12 weeks prior to Screening).
    •≥18 years old
    •Adequate renal function by:
    - Estimated creatinine clearance ≥60 mL/min according to the Cockcroft Gault formula
    •Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
    •Total bilirubin ≤ 1.5 mg/dL
    •Adequate hematologic function (absolute neutrophil count ≥1,000/mm3; platelets ≥25,000/mm3; hemoglobin ≥8.0 g/dL
    •Serum amylase ≤ 1.5 x ULN (subjects with serum amylase > 1.5 x ULN will remain eligible if serum lipase is ≤ 1.5 x ULN)
    •Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least two years post-menopausal)
    •Women of childbearing potential (WOCBP) must be willing to use two methods of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drugs in such a manner that the risk of pregnancy is minimized.
    •Female subjects who utilize hormone contraceptive as one of their birth control methods must have used the same methods for at least three months prior to study dosing.
    •Female subjects who are postmenopausal for less than two years are required to have FSH ≥ 40 mIU/mL. If the FSH is < 40 mIU/mL, the subject must agree to use highly effective method of birth control (as described above) to participate in the study
    •Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condom with spermicide) during heterosexual intercourse from screening through completion of the study and continuing for up to 12 weeks after the last dose of study drugs
    •Life expectancy ≥1 year
    •The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    E.4Principal exclusion criteria
    •Subjects who have been treated with any ARV other than Truvada, tenofovir DF,
    emtricitabine, lamivudine or efavirenz
    • Known hypersensitivity or toxicities to emtricitabine (FTC), tenofovir DF (TDF) or
    Truvada
    • Known hypersensitivity or toxicities to lamivudine (3TC) if the subject initiated HAART with tenofovir DF, lamivudine, and efavirenz
    •Known hypersensitivity or toxicities to Sustiva
    •Have a history of resistance to any of the study agents at the time of screening (documented presence of resistance mutation(s) as defined by the IAS-USA 2005 Guidelines
    •A new AIDS-defining condition diagnosed within the 30 days prior to the Baseline visit.
    •Pregnant or lactating or breastfeeding females
    •Severe hepatic impairment (> 5 times upper limit of normal as defined by laboratory transaminases) or deemed clinically significant by investigator.
    •Any current know clinical or laboratory parameter of GSI grade 4. However asymptomatic grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding AEs and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment.
    •Receiving on-going therapy with any of the prohibited medications. Administration of any of the medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period.
    •Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy within 30 days prior to Screening visit.
    •Current acute illness or infection (e.g., opportunistic) – including an active AIDS defining condition within the previous six months.
    •Hepatitis B co-infection or Hepatitis C co-infection
    •Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS with 30 days of Baseline visit and are not anticipated to require systemic therapy during the study.
    •Prior history of renal or bone disease deemed significant by the investigator.
    •Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied has been stopped for more than 1 month.
    •Evidence of alcohol and/or drug or substance abuse that in the judgment of the investigator would likely result in the patient being unreliable in fulfilling the conditions of the protocol.
    •History of psychological illness or conditions that in the judgment of the investigator might interfere with the patient’s ability to understand the requirements of the study.
    •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements and cause the patient to be unable to complete the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who maintain pure virologic response at HIV-1 RNA threshold of 50 copies /mL (PVR50; lack of confirmed HIV-1 RNA level ≥50 copies/mL) through Week 48.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Assessment of adherence of dosing recommendations and acceptability via questionnaires through Wk 48
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Last Patient Last Visit (LPLV) is defined as the last protocol required follow up visit
    completed by a subject enrolled in this study.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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 state150
    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 Decision2008-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-20
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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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