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Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

20. August 2018 aktualisiert von: ViiV Healthcare

A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

210

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, 1141
        • GSK Investigational Site
      • Buenos Aires, Argentinien, 1202
        • GSK Investigational Site
      • Córdoba, Argentinien, X5000JJS
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinien, C1181ACH
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentinien, 2000
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8360159
        • GSK Investigational Site
      • Santiago, Chile, 7560994
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
  • Deutschland
      • Berlin, Deutschland, 13353
        • GSK Investigational Site
      • Berlin, Deutschland, 12157
        • GSK Investigational Site
      • Dortmund, Deutschland, 44137
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Deutschland, 80335
        • GSK Investigational Site
      • Muenchen, Bayern, Deutschland, 80336
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Deutschland, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Deutschland, 53127
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Deutschland, 40225
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Deutschland, 45122
        • GSK Investigational Site
  • Frankreich
      • Le Kremlin-Bicêtre, Frankreich, 94276
        • GSK Investigational Site
      • Lyon cedex 04, Frankreich, 69317
        • GSK Investigational Site
      • Nantes, Frankreich, 44093
        • GSK Investigational Site
      • Nice, Frankreich, 06202
        • GSK Investigational Site
      • Paris, Frankreich, 75013
        • GSK Investigational Site
      • Paris, Frankreich, 75012
        • GSK Investigational Site
      • Paris Cedex 10, Frankreich, 75475
        • GSK Investigational Site
  • Italien
    • Lombardia
      • Bergamo, Lombardia, Italien, 24127
        • GSK Investigational Site
      • Milano, Lombardia, Italien, 20127
        • GSK Investigational Site
      • Milano, Lombardia, Italien, 20157
        • GSK Investigational Site
      • Monza, Lombardia, Italien, 20900
        • GSK Investigational Site
  • Kanada
      • Quebec, Kanada, G1V 4G2
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2G3
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3A 1R9
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada, H3A 1T1
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H4A 3J1
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2L 5B1
        • GSK Investigational Site
  • Mexiko
      • DF, Mexiko, 14000
        • GSK Investigational Site
      • Durango, Mexiko, 34000
        • GSK Investigational Site
      • Mexico City, Mexiko, CP 14080
        • GSK Investigational Site
    • Aguascalientes
      • Fracc. Las Americas, Aguascalientes, Mexiko, 20020
        • GSK Investigational Site
    • Guanajuato
      • León, Guanajuato, Mexiko, 37000
        • GSK Investigational Site
  • Polen
      • Bydgoszcz, Polen, 85-030
        • GSK Investigational Site
      • Szczecin, Polen, 71-252
        • GSK Investigational Site
      • Warszawa, Polen, 01-201
        • GSK Investigational Site
      • Wroclaw, Polen, 50-220
        • GSK Investigational Site
  • Spanien
      • Alcala de Henares, Spanien, 28805
        • GSK Investigational Site
      • Badalona, Spanien, 08916
        • GSK Investigational Site
      • Madrid, Spanien, 28040
        • GSK Investigational Site
      • Madrid, Spanien, 28034
        • GSK Investigational Site
      • Santiago de Compostela, Spanien, 15706
        • GSK Investigational Site
  • Südafrika
    • Free State
      • Bloemfontein, Free State, Südafrika, 9301
        • GSK Investigational Site
  • Vereinigte Staaten
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • GSK Investigational Site
      • Los Angeles, California, Vereinigte Staaten, 90036
        • GSK Investigational Site
    • Florida
      • DeLand, Florida, Vereinigte Staaten, 32720
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30312
        • GSK Investigational Site
      • Decatur, Georgia, Vereinigte Staaten, 30033
        • GSK Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, Vereinigte Staaten, 87505
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74135
        • GSK Investigational Site
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • GSK Investigational Site
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich, E1 1BB
        • GSK Investigational Site
      • London, Vereinigtes Königreich, W2 1NY
        • GSK Investigational Site
      • London, Vereinigtes Königreich, SW10 9NH
        • GSK Investigational Site
      • Tooting, London, Vereinigtes Königreich, SW17 0QT
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, Vereinigtes Königreich, EH4 2XU
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Men and non-pregnant women, at least 18 years of age
  • Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug
  • Plasma HIV-1 RNA ≥ 1000 copies/mL
  • CD4 T-cell count > 200 cells/mm3

Exclusion Criteria:

  • Resistance or partial resistance to any study drug determined by tests at Screening
  • Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
  • Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
  • Blood tests that indicate normal liver function
  • Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm 1: BMS-955176 60 mg + TDF/FTC
BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally
Arzneimittel: BMS-955176
HIV-Reifungsinhibitor
Arzneimittel: TDF/FTC
TDF/FTC
Experimental: Arm 2: BMS-955176 120 mg + TDF/FTC
BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally
Arzneimittel: BMS-955176
HIV-Reifungsinhibitor
Arzneimittel: TDF/FTC
TDF/FTC
Experimental: Arm 3: BMS-955176 180 mg + TDF/FTC
BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally
Arzneimittel: BMS-955176
HIV-Reifungsinhibitor
Arzneimittel: TDF/FTC
TDF/FTC
Aktiver Komparator: Arm 4: EFV + TDF/FTC
BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day
Arzneimittel: TDF/FTC
TDF/FTC
Arzneimittel: EFV
EFV

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm
Zeitfenster: Week 24
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.
Week 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
Zeitfenster: Weeks 48 and 96
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Weeks 48 and 96
Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm
Zeitfenster: Week 24
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.
Week 24
Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
Zeitfenster: Weeks 48 and 96
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Weeks 48 and 96
Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates
Zeitfenster: Week 24
The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.
Week 24
Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates
Zeitfenster: Week 24
Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.
Week 24
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time
Zeitfenster: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time
Zeitfenster: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Change From Baseline in the Percentage of CD4+ T-cells Over Time
Zeitfenster: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)
Zeitfenster: Up to Week 96
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized.
Up to Week 96
Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events
Zeitfenster: Up to Week 96
The occurrence of new AIDS defining events that is CDC class C events is presented.
Up to Week 96
Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795
Zeitfenster: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.
Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795
Zeitfenster: Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Serial blood samples were collected at indicated time points for intensive PK assessment.
Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795
Zeitfenster: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Serial blood samples were collected at indicated time points for intensive PK assessment.
Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ViiV Healthcare

Mitarbeiter

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Mai 2015

Primärer Abschluss (Tatsächlich)

26. Mai 2016

Studienabschluss (Tatsächlich)

21. August 2017

Studienanmeldedaten

Zuerst eingereicht

11. März 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. April 2015

Zuerst gepostet (Schätzen)

14. April 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. September 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. August 2018

Zuletzt verifiziert

1. August 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 205891
  • 2013-005487-26 (EudraCT-Nummer)
  • AI468-038 (Andere Kennung: Bristol-Myers Squibb)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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