- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02263326
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
California
-
San Diego, California, Förenta staterna
- University of California San Diego
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna
- Emory University
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna
- Brigham and Women's Hospital
-
-
New York
-
New York, New York, Förenta staterna
- Cornell University
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna
- University of Cincinnati
-
Columbus, Ohio, Förenta staterna
- The Ohio State University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: dolutegravir plus lamivudine
dolutegravir 50 mg plus lamivudine 300 mg once daily
|
50 mg tablet by mouth once daily for 48 weeks
Andra namn:
300 mg tablet by mouth once daily for 48 weeks
Andra namn:
|
Aktiv komparator: Continue current ART regimen
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
|
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of Participants With Treatment Failure
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of Participants With Virologic Success
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 48 weeks
|
Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure
|
48 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Residual Viremia by HIV-1 Single-copy Assay
Tidsram: 48 weeks
|
Difference in HIV-1 detection by the HIV-1 single copy assay between arms will be presented in statistical analysis
|
48 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Babafemi Taiwo, MBBS, Northwestern University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- HIV-infektioner
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Omvända transkriptashämmare
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Anti-HIV-medel
- HIV-integrashämmare
- Integrashämmare
- Lamivudin
- Antiretrovirala medel
- Dolutegravir
Andra studie-ID-nummer
- ASPIRE
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HIV-infektion
-
Institut PasteurRekrytering
-
Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
-
Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
-
University of MalayaTeleflexRekryteringCLABSI - Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
-
National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
Boston Children's HospitalSterileCare Inc.Anmälan via inbjudanCentral Line komplikation | Central Line-associated Bloodstream Infection (CLABSI)Förenta staterna
Kliniska prövningar på dolutegravir
-
ViiV HealthcareAvslutad
-
ViiV HealthcareGlaxoSmithKlineAvslutadHIV-infektionerFörenta staterna
-
University of KwaZuluCentre for the AIDS Programme of Research in South AfricaRekryteringTuberkulos | HivSydafrika
-
ViiV HealthcareGlaxoSmithKlineAvslutadInfektion, humant immunbristvirusFörenta staterna
-
Fundación HuéspedViiV HealthcareAvslutadDolutegravir-Lamivudin som dubbelterapi hos naiva HIV-infekterade patienter: en pilotstudie (PADDLE)HIV-1-infektionArgentina
-
ViiV HealthcareGlaxoSmithKline; ShionogiAvslutadInfektioner, humant immunbristvirus och HerpesviridaeFörenta staterna
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development... och andra samarbetspartnersRekryteringHIVFörenta staterna, Brasilien, Puerto Rico, Sydafrika, Thailand
-
ViiV HealthcareJanssen Research & Development, LLCRekryteringHIV-infektionerFörenta staterna
-
Thomas BenfieldRekryteringHjärt-kärlsjukdomar | HIV-infektioner | Hiv | Viktförändring, kropp | HIV-lipodystrofi | HIV kardiomyopatiDanmark
-
ViiV HealthcareGlaxoSmithKline; ShionogiAvslutad