Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003197-27
    Sponsor's Protocol Code Number:RC13_0230
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-09-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-003197-27
    A.3Full title of the trial
    Phase 2 multicentric open-label study of switch from abacavir/lamivudine fixed dose combination plus nevirapine to abacavir/lamivudine/dolutegravir in virologically suppressed HIV-1 infected adults
    A.3.2Name or abbreviated title of the trial where available
    SWAD
    A.4.1Sponsor's protocol code numberRC13_0230
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Nantes
    B.1.3.4CountryFrance
    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 supportViiV Healthcare
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointKarine NEAU
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'Ile Gloriette
    B.5.3.2Town/ cityNANTES
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0253482850
    B.5.5Fax number0253482836
    B.5.6E-mailkarine.neau@chu-nantes.fr
    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 nameDolutegravir/Abacavir/Lamivudine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 Viramune LP
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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-1 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate virologic safety, e.g. maintenance of virologic suppression, after 12 weeks of switch from NVP + ABC/3TC to DTG/ABC/3TC.
    E.2.2Secondary objectives of the trial
    - to evaluate pharmacokinetic of NVP and DTG after swtiching from NVP to DTG. The objective is to assess residual concentrations of NVP over 2 weeks following NVP cessation and Cmin of DTG over the first 12 weeks following NVP-DTG switch to determine the extent of potential inducing effect of NVP on DTG.
    - to assess DTG PK with and without concomitant NVP administration
    - to assess maintenance of virologic suppression through 48 weeks
    - to evaluate safety and tolerability
    - to evaluate treatment satisfaction
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics evaluation.
    To further address potential drug-drug interaction, a subgroup of 10 patients (Group 2) will have an overlap of 5 days, receiving both NVP-XR and ABC/3TC/DTG, before stopping NVP-XR and continuing solely ABC/3TC/DTG. A 24h pharmacokinetics evaluation of both NVP and DTG will be performed in these 10 patients at Day 0 (at steady-state, 5 days after concomitant intake of NVP-XR + ABC/3TC/DTG) and of DTG at Week 2 (14 days after NVP discontinuation).
    E.3Principal inclusion criteria
    • Patient with confirmed HIV-1 infection (HIV antibody positive confirmation prior to screening)
    • Age ≥ 18 years
    • Written informed consent
    • Male patient or non-pregnant, non-lactating female patient
    (Women of childbearing age must have a negative serum pregnancy test at screening. All female participants of childbearing potential must use contraception for the month preceding study entry and for the entire duration of the study. Recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
    • On antiretroviral treatment with nevirapine (400 mg per day) plus abacavir/lamivudine for more than 6 months
    • No history of prior virologic failure on antiretroviral therapy
    • HIV-1 RNA < 50 copies/ml for more than 1 year,
    • No major IAS-USA nucleoside reverse transcriptase inhibitors or integrase inhibitors resistance mutations on genotypic testing on last plasma sample with HIV-1 RNA > 500 c/mL (if available)
    • HLA-B*5701 negative test
    • Subjects covered by Health Insurance
    E.4Principal exclusion criteria
    • Woman of child-bearing potential without effective contraception method.
    For contraception during the trial all women must use a combination of mechanical method and a second method other than an oral contraceptive. Oral contraceptives are not to be used during the trial. Pregnant or breastfeeding woman.
    • Woman expecting to conceive during the study period
    • HIV-2 co-infection
    • Any prior exposure to integrase inhibitor(s)
    • plasma HIV-1 RNA > 50 c/mL in the past year
    • Creatinine clearance < 60 ml/mn (estimated glomerular filtration rate according to the MDRD equation),
    • Alkaline phosphatase, ASAT or ALAT ≥ 5 times the upper limit of the norm (ULN)
    • Patient with history of decompensated liver disease
    • Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or integrase inhibitors on genotypic testing at screening (DNA genotype) or on any historical plasma genotype if available. Any previous genotype result is valid, with no time limit, as long as the original test result is documented.
    • Mycobacteriosis under treatment
    • Malignancy requiring chemotherapy or radiotherapy
    • Positive HBs Ag
    • HCV infection for which specific treatment is ongoing or planned during the study
    • Known hypersensitivity to one of the trial drugs, the metabolites or formulation excipients
    • Concomitant therapy with antacids or H2 antagonists
    • Contraindicated concomitant treatment
    • Anticipated non-compliance with the protocol
    • Participation in another clinical trial with an on-going exclusion period at screening
    • Subject under legal guardianship or incapacitation
    • Subject, who in the opinion of the investigator, is unable to complete the study period
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients maintaining plasma HIV-1 RNA below 50 copies/mL at week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    - 24h PK parameters of DTG (D0, after 5 days of combination of ABC/3TC + NVP + DTG) with and without NVP (D14)
    - Plasma HIV-1 RNA < 50 c/ml at W24
    - Plasma HIV-1 RNA < 50 c/ml at W48
    - Proportion of patients with undetectable plasma viral load (< 1 c/ml or signal not detected) at D0, W12, W24, W36, W48
    - Proportion with AE of any Grade over 12 weeks
    - Proportion of patients with AE of Grade 3 or 4 over 48 weeks
    - Proportion of patients with AE leading to treatment discontinuation
    - Changes in CD4 and CD8 counts over 48 weeks
    - Changes in serum creatinine, and GFR (MDRD) from W2 to W48
    - Change in urinary albumine:creatinine ratio over 48 weeks
    - Changes in fasting lipids over 48 weeks
    - Mean Cmin of nevirapine between W0 and W2 (D0, W1, W2)
    - Mean Cmin of dolutegravir between W0 and W12 (W1, W2, W4, W12)
    - Patient’s satisfaction, evaluated with self-administered questionnaires HIVTSQs and HIVTSQc
    - Changes in sCD14 and usCRP over 48 weeks (stored plasma)
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 concerned2
    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 No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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 Yes
    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 state53
    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)
    If Dolutegravir/Abacavir/Lamivudine is not yet labelled at the end of the study, ViiV Healthcare will provide the drug until its marketing.
    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 Decision2013-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 04 05:35:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA