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A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)

7. prosince 2015 aktualizováno: ViiV Healthcare

A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit.

ViiV Healthcare is the sponsor of this study.

Typ studie

Intervenční

Zápis (Aktuální)

183

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Bruxelles, Belgie, 1000
        • GSK Investigational Site
      • Liege, Belgie, 4000
        • GSK Investigational Site
  • Francie
      • Aulnay-sous-Bois, Francie, 93602
        • GSK Investigational Site
      • Bobigny, Francie, 93009
        • GSK Investigational Site
      • Bordeaux, Francie, 33000
        • GSK Investigational Site
      • Garches, Francie, 92380
        • GSK Investigational Site
      • Gonesse cedex, Francie, 95503
        • GSK Investigational Site
      • Marseille, Francie, 13003
        • GSK Investigational Site
      • Marseille, Francie, 13009
        • GSK Investigational Site
      • Nice, Francie, 06202
        • GSK Investigational Site
      • Orléans Cedex 2, Francie, 45067
        • GSK Investigational Site
      • Paris, Francie, 75018
        • GSK Investigational Site
      • Paris Cedex 10, Francie, 75475
        • GSK Investigational Site
      • Paris Cedex 13, Francie, 75651
        • GSK Investigational Site
      • Paris Cedex 20, Francie, 75970
        • GSK Investigational Site
      • Paris cedex 14, Francie, 75679
        • GSK Investigational Site
      • Paris cedex 15, Francie, 75743
        • GSK Investigational Site
  • Itálie
    • Liguria
      • Genova, Liguria, Itálie, 16138
        • GSK Investigational Site
    • Lombardia
      • Bergamo, Lombardia, Itálie, 24127
        • GSK Investigational Site
      • Milano, Lombardia, Itálie, 20127
        • GSK Investigational Site
    • Piemonte
      • Torino, Piemonte, Itálie, 10149
        • GSK Investigational Site
    • Toscana
      • Bagno a Ripoli (FI), Toscana, Itálie, 50011
        • GSK Investigational Site
      • Firenze, Toscana, Itálie, 50134
        • GSK Investigational Site
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6Z 2C7
        • GSK Investigational Site
      • Vancouver, British Columbia, Kanada, V6Z 1Y6
        • GSK Investigational Site
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 3Z5
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M4N 3M5
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M5B 1L6
        • GSK Investigational Site
      • Toronto, Ontario, Kanada, M4T 3A7
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada, H3G 1A4
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2X 2P4
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2W 1T8
        • GSK Investigational Site
      • Montreal, Quebec, Kanada, H2L 5B1
        • GSK Investigational Site
  • Portugalsko
      • Amadora, Portugalsko
        • GSK Investigational Site
      • Coimbra, Portugalsko, 3030
        • GSK Investigational Site
      • Lisboa, Portugalsko, 1649-035
        • GSK Investigational Site
      • Lisboa, Portugalsko, 1150
        • GSK Investigational Site
      • Lisboa, Portugalsko, 1349-019
        • GSK Investigational Site
  • Spojené státy
    • California
      • Beverly Hills, California, Spojené státy, 90211
        • GSK Investigational Site
      • Fountain Valley, California, Spojené státy, 92708
        • GSK Investigational Site
      • Los Angeles, California, Spojené státy, 90069
        • GSK Investigational Site
      • Los Angeles, California, Spojené státy, 90033
        • GSK Investigational Site
      • San Diego, California, Spojené státy, 92103-8208
        • GSK Investigational Site
      • San Francisco, California, Spojené státy, 94109
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Spojené státy, 06510
        • GSK Investigational Site
      • Norwalk, Connecticut, Spojené státy, 06850
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Spojené státy, 20007
        • GSK Investigational Site
      • Washington, District of Columbia, Spojené státy, 20009
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, Spojené státy, 33316
        • GSK Investigational Site
      • Fort Pierce, Florida, Spojené státy, 34982
        • GSK Investigational Site
      • Miami Beach, Florida, Spojené státy, 33139
        • GSK Investigational Site
      • Orlando, Florida, Spojené státy, 32804
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30308
        • GSK Investigational Site
      • Augusta, Georgia, Spojené státy, 30912
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Spojené státy, 70506
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02115
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, Spojené státy, 39216-4505
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89106
        • GSK Investigational Site
    • New Jersey
      • Newark, New Jersey, Spojené státy, 07103
        • GSK Investigational Site
    • New York
      • Albany, New York, Spojené státy, 12209
        • GSK Investigational Site
      • Bronx, New York, Spojené státy, 10461
        • GSK Investigational Site
      • Bronx, New York, Spojené státy, 10467
        • GSK Investigational Site
      • Buffalo, New York, Spojené státy, 14215
        • GSK Investigational Site
      • New York, New York, Spojené státy, 10016
        • GSK Investigational Site
      • New York, New York, Spojené státy, 10011
        • GSK Investigational Site
      • Valhalla, New York, Spojené státy, 10595
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • GSK Investigational Site
      • Durham, North Carolina, Spojené státy, 27710
        • GSK Investigational Site
    • Ohio
      • Toledo, Ohio, Spojené státy, 43614
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Spojené státy, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02906
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Spojené státy, 78705
        • GSK Investigational Site
      • Dallas, Texas, Spojené státy, 75246
        • GSK Investigational Site
      • Dallas, Texas, Spojené státy, 75204
        • GSK Investigational Site
      • Houston, Texas, Spojené státy, 77004
        • GSK Investigational Site
      • Houston, Texas, Spojené státy, 77098
        • GSK Investigational Site
    • Virginia
      • Annandale, Virginia, Spojené státy, 22003
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Spojené státy, 98104
        • GSK Investigational Site
  • Španělsko
      • Alicante, Španělsko, 03010
        • GSK Investigational Site
      • Badalona, Španělsko, 08916
        • GSK Investigational Site
      • Barcelona, Španělsko, 08036
        • GSK Investigational Site
      • La Coruña, Španělsko, 15006
        • GSK Investigational Site
      • Madrid, Španělsko, 28046
        • GSK Investigational Site
      • Madrid, Španělsko, 28034
        • GSK Investigational Site
      • Madrid, Španělsko, 28029
        • GSK Investigational Site
      • Sevilla, Španělsko, 41013
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Screening plasma HIV-1 RNA ≥500 copies/mL
  • ART-experienced, INI-experienced, DTG naïve
  • Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen
  • The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time point of virological failure on RAL or ELV
  • Documented resistance to at least one drug from each of three or more of all approved classes of ART
  • Be able to receive at least one fully active drug as part of the OBR from Day 8
  • Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
  • Willing and able to understand and provide signed and dated written informed consent prior to Screening.

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3)
  • Moderate to severe hepatic impairment as defined by Child-Pugh classification
  • Anticipated need for HCV therapy during the first 24 weeks of the study
  • Recent history of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
  • Allergy or intolerance to the study drugs or their components or drugs of their class
  • Malignancy within the past 6 months
  • Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening
  • Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
  • Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
  • Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinivir/ritonavir or darunavir/ritonavir)
  • Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening
  • Verified Grade 4 laboratory abnormality at Screening
  • ALT> 5 times the upper limit of normal (ULN) at Screening
  • ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: dolutegravir
dolutegravir plus background antiretroviral therapy optimised at Day 8
Lék: dolutegravir
50 mg twice daily

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8
Časové okno: Baseline and Day 8
Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.
Baseline and Day 8
Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24
Časové okno: Week 24
The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.
Week 24
Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
Časové okno: Week 48
The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.
Week 48
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Časové okno: Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48
The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window
Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion
Časové okno: From Week 48 every 12 weeks up to study completion.
The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
From Week 48 every 12 weeks up to study completion.
Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion
Časové okno: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)
Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)
Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48
Časové okno: Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.
Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion
Časové okno: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v
Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v
Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48
Časové okno: Baseline; Weeks 4, 12, 24, and 48
The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.
Baseline; Weeks 4, 12, 24, and 48
Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
Cmax and Ctau of DTG
Časové okno: Day 8, Week 4, and Week 24
The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.
Day 8, Week 4, and Week 24
AUC(0-tau) and AUC(0-24) of DTG
Časové okno: Day 8, Week 4, and Week 24
The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.
Day 8, Week 4, and Week 24
C0 Assessment of DTG
Časové okno: Day 8, Week 4, and Week 24
The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.
Day 8, Week 4, and Week 24
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
Časové okno: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)
The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).
From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

ViiV Healthcare

Spolupracovníci

GlaxoSmithKline
Shionogi

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2011

Primární dokončení (Aktuální)

1. května 2012

Dokončení studie (Aktuální)

1. května 2015

Termíny zápisu do studia

První předloženo

31. března 2011

První předloženo, které splnilo kritéria kontroly kvality

31. března 2011

První zveřejněno (Odhad)

4. dubna 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

7. ledna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. prosince 2015

Naposledy ověřeno

1. prosince 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 112574

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

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