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Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)

10. oktober 2019 opdateret af: Babafemi Taiwo

Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study

HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

DESIGN HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24

All subjects will undergo routine monitoring including plasma HIV-1 RNA, CD4/CD8 count, hematology, chemistry and fasting lipids. Resistance testing will be done in all patients who experience virologic failure. Single-copy HIV-1 assay will be done to quantify residual viremia.

DURATION 48 weeks

SAMPLE SIZE 90 subjects

POPULATION HIV-1-infected men and women, 18 years and older, with CD4 nadir > 200 cells/mm3, no baseline resistance, no history of virologic failure, and HIV RNA <50 copies/mL for at least 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug regimen

REGIMEN Subjects will be randomized (1:1) to:

Arm 1: dolutegravir 50 mg plus lamivudine 300 mg once daily OR Arm 2: Continue current DHHS recommended or alternative three-drug antiretroviral regimen

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

89

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater
        • University of California San Diego
    • Georgia
      • Atlanta, Georgia, Forenede Stater
        • Emory University
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Brigham and Women's Hospital
    • New York
      • New York, New York, Forenede Stater
        • Cornell University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • University of Cincinnati
      • Columbus, Ohio, Forenede Stater
        • The Ohio State University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • HIV-1 Infection
  • HIV-1 RNA <50 copies/mL on all measurements within 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug antiretroviral regimen. (A history of switching for simplification and/or tolerability is allowed. At least two measurements within the previous 48 weeks are required prior to study screening.)
  • No history of virologic failure, defined as consecutive HIV RNA > 50 copies/mL after 12 months of initiating ART. An isolated (non-consecutive) HIV RNA > 50 copies/mL (but less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the 48-week window prior to study entry.
  • Screening plasma HIV RNA < 20 copies/mL using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test V2.0, obtained within 45 days prior to study entry
  • Nadir CD4 count >200 cells/mm
  • Pretreatment genotype documenting no mutations in the protease or reverse transcriptase genes
  • No known resistance to integrase inhibitors
  • Laboratory values obtained within 45 days prior to study entry:

ANC >750 Hemoglobin >10 g/dL Platelets >50,000 Calculated creatinine clearance (CrCl) >50 mL/min

  • Negative serum or urine pregnancy test
  • Men and women age greater or equal to 18 years.
  • Ability to continue current regimen (i.e, have uninterrupted access)
  • No evidence of chronic hepatitis B

Exclusion Criteria:

  • Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
  • Treatment within 30 days prior to study entry with immune modulators
  • Vaccination within 7 days
  • Active HCV treatment or anticipated need for treatment within study period. (HCV infection alone is not exclusionary)
  • Unstable liver disease or severe hepatic impairment
  • Known allergy or hypersensitivity to DTG or lamivudine.
  • Active drug or alcohol use or dependence that could interfere with adherence to study requirements
  • ALT (alanine aminotransferase) >5 x ULN (upper limit of normal) OR ALT >3 x ULN and total bilirubin >1.5 x ULN (with 35% direct bilirubin)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: dolutegravir plus lamivudine
dolutegravir 50 mg plus lamivudine 300 mg once daily
Medicin: dolutegravir
50 mg tablet by mouth once daily for 48 weeks
Andre navne:
  • TIVICAY, DTG
Medicin: lamivudine
300 mg tablet by mouth once daily for 48 weeks
Andre navne:
  • EPIVIR, 3TC
Aktiv komparator: Continue current ART regimen
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
Medicin: Continue current antiretroviral regimen
Continue current DHHS recommended or alternative three-drug antiretroviral regimen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Treatment Failure
Tidsramme: 24 weeks
Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Virologic Success
Tidsramme: 48 weeks
Proportion of participants with virologic success (<50 copies/mL) based on FDA snapshot definition
48 weeks
Change in CD4 Count From Baseline to Week 48
Tidsramme: Baseline and 48 weeks
Change in CD4 count between arms will be presented in the attached statistical analysis table
Baseline and 48 weeks
Change in Total Cholesterol From Baseline to Week 48
Tidsramme: Baseline and 48 weeks
Change in Total Cholesterol between arms will be presented in the attached statistical analysis table
Baseline and 48 weeks
Change in LDL Cholesterol From Baseline to Week 48
Tidsramme: Baseline and Week 48
Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table
Baseline and Week 48
Change in Creatinine Clearance From Baseline to Week 48
Tidsramme: Baseline and Week 48
Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table
Baseline and Week 48
Drug Resistance Associated Mutations
Tidsramme: 48 weeks
Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure
48 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residual Viremia by HIV-1 Single-copy Assay
Tidsramme: 48 weeks
Difference in HIV-1 detection by the HIV-1 single copy assay between arms will be presented in statistical analysis
48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Babafemi Taiwo

Samarbejdspartnere

ViiV Healthcare

Efterforskere

  • Ledende efterforsker: Babafemi Taiwo, MBBS, Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2014

Primær færdiggørelse (Faktiske)

1. juli 2017

Studieafslutning (Faktiske)

1. september 2017

Datoer for studieregistrering

Først indsendt

6. oktober 2014

Først indsendt, der opfyldte QC-kriterier

8. oktober 2014

Først opslået (Skøn)

13. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ASPIRE

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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