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Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02246998
Collaborator
(none)
72
Enrollment
20
Locations
4
Arms
14.1
Actual Duration (Months)
3.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min
Actual Study Start Date :
Dec 15, 2014
Actual Primary Completion Date :
Jan 20, 2016
Actual Study Completion Date :
Feb 17, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: STB+iohexol

Participants will receive STB+iohexol for 24 weeks.

Drug: STB
150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
Other Names:
  • Stribild®

    • Drug: Iohexol
    1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
    Other Names:
  • Omnipaque™

    		•
    Experimental: RTV+ATV+TVD+iohexol

    Participants will receive RTV+ATV+TVD+iohexol for 24 weeks.

    Drug: TVD
    200/300 mg FDC tablet administered orally once daily with food
    Other Names:
  • Truvada®

    • Drug: RTV
    100 mg tablet administered orally once daily with food
    Other Names:
  • Norvir®

    • Drug: ATV
    300 mg capsule administered orally once daily with food
    Other Names:
  • Reyataz®

    • Drug: Iohexol
    1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
    Other Names:
  • Omnipaque™

    		•
    Experimental: ATR+iohexol

    Participants will receive ATR+iohexol for 24 weeks.

    Drug: ATR
    600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
    Other Names:
  • Atripla®

    • Drug: Iohexol
    1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
    Other Names:
  • Omnipaque™

    		•
    Experimental: RTV+ATV+ABC/3TC+iohexol

    Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.

    Drug: RTV
    100 mg tablet administered orally once daily with food
    Other Names:
  • Norvir®

    • Drug: ATV
    300 mg capsule administered orally once daily with food
    Other Names:
  • Reyataz®

    • Drug: ABC/3TC
    600/300 mg FDC tablet administered orally once daily with food
    Other Names:
  • Kivexa®

    • Drug: Iohexol
    1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
    Other Names:
  • Omnipaque™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24 [Week 24]

    2. Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24 [Week 24]

      GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL

    3. Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24 [Week 24]

      MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL

    Secondary Outcome Measures

    1. Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick) [Up to 24 weeks plus 30 days]

    2. Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting) [Up to 24 weeks plus 30 days]

    3. Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24 [Baseline; Week 24]

    4. Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24 [Baseline; Week 24]

    5. Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24 [Baseline; Week 24]

    6. Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24 [Baseline; Week 24]

    7. Pharmacokinetic (PK) Parameter: Cmax for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Cmax is defined as the maximum observed concentration of drug in plasma.

    8. PK Parameter: Tmax for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Tmax is defined as the time of Cmax.

    9. PK Parameter: Clast for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Clast is defined as the last observable concentration of drug.

    10. PK Parameter: Tlast for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Tlast is defined as the time of Clast. Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

    11. PK Parameter: Ctau for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Ctau is defined as the observed drug concentration at the end of the dosing interval.

    12. PK Parameter: λz for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      λz is defined as the terminal elimination rate constant.

    13. PK Parameter: AUCtau for COBI [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).

    14. PK Parameter: t1/2 for COBI [Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

    15. PK Parameter: Cmax for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    16. PK Parameter: Tmax for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    17. PK Parameter: Clast for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    18. PK Parameter: Tlast for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

    19. PK Parameter: Ctau for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    20. PK Parameter: AUCtau for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    21. PK Parameter: λz for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    22. PK Parameter: t1/2 for RTV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    23. PK Parameter: Cmax for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    24. PK Parameter: Tmax for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    25. PK Parameter: Clast for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    26. PK Parameter: Tlast for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

      Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.

    27. PK Parameter: Ctau for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    28. PK Parameter: λz for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    29. PK Parameter: AUCtau for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    30. PK Parameter: t1/2 for TFV [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24]

    31. PK Parameter: AUCinf for Iohexol [Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Day 1 and Weeks 4, 8, 16, and 24]

      AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).

    32. Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm [Week 24]

    33. Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24 [Baseline; Week 24]

    34. Percentage of Participants Experiencing Adverse Events (AEs) [Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)]

      Incidences of adverse events and laboratory abnormalities will be summarized.

    35. Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities [Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)]

      Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Treatment naïve

    • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at Screening

    • CD4 cell count > 200 cells/µL

    • Screening genotype report provided by the site must show sensitivity to FTC, TDF, EFV, ABC, 3TC, ATV and absence of study drug resistance mutations that include K65R, K70E and M184V in RT

    • Estimated GFR ≥ 70 mL/min

    • Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 × upper limit of normal (ULN)

    • Total bilirubin ≤ 1.5 mg/dL (≤ 26 umol/L), or normal direct bilirubin

    • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.5 g/dL)

    • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)

    • Normal electrocardiogram (ECG) or not clinically significant if abnormal ECG

    • Not pregnant or non-lactating females of non-childbearing potential. Or females with childbearing potential who agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose

    • Males who agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose. Males who agree to refrain from sperm donation from first dose until at least 90 days if taking EFV/FTC/TDF or for 30 days for all other study drugs following the last study drug dose

    • Body mass index (BMI) of 19 ≤ BMI ≤ 30 kg/m^2 and body weight ≥ 40 kg

    • Life expectancy ≥ 1 year

    Key Exclusion Criteria:

    • HLA-B*5701 allele positive

    • A new AIDS-defining condition diagnosed within the 30 days prior to screening

    • Hepatitis B surface antigen (HBsAg) positive

    • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable

    • Individuals experiencing decompensated cirrhosis

    • Females who are breastfeeding

    • Positive serum pregnancy test

    • Have an implanted defibrillator or pacemaker

    • Current alcohol or substance that could potentially interfere with study compliance

    • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 Visit and must not be anticipated to require systemic therapy during the study

    • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brussels Belgium
    2 Ghent Belgium
    3 Lyon France
    4 Paris France
    5 Rennes France
    6 Tourcoing France
    7 Dublin Ireland
    8 Barcelona Spain
    9 Madrid Spain
    10 Seville Spain
    11 Birmingham United Kingdom
    12 Bournemouth United Kingdom
    13 Brighton United Kingdom
    14 Bristol United Kingdom
    15 Coventry United Kingdom
    16 Liverpool United Kingdom
    17 London United Kingdom
    18 Manchester United Kingdom
    19 Newcastle United Kingdom
    20 Sheffield United Kingdom

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02246998
    Other Study ID Numbers:
    • GS-US-236-0140
    • 2014-002095-93
    First Posted:
    Sep 23, 2014
    Last Update Posted:
    Jan 3, 2018
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in Belgium, Ireland, Spain, and the United Kingdom. The first participant was screened on 15 Dec 2014. The last study visit occurred on 17 February 2016.
    Pre-assignment Detail 93 participants were screened.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Period Title: Overall Study
    STARTED 18 18 18 18
    COMPLETED 16 15 15 16
    NOT COMPLETED 2 3 3 2

    Baseline Characteristics

    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol Total
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 Total of all reporting groups
    Overall Participants 17 16 16 17 66
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36
    (8.1)
    34
    (8.4)
    34
    (9.6)
    34
    (7.5)
    35
    (8.3)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    6.3%
    1
    6.3%
    0
    0%
    2
    3%
    Male
    17
    100%
    15
    93.8%
    15
    93.8%
    17
    100%
    64
    97%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    1
    5.9%
    0
    0%
    0
    0%
    0
    0%
    1
    1.5%
    Asian
    1
    5.9%
    0
    0%
    0
    0%
    1
    5.9%
    2
    3%
    Black
    2
    11.8%
    1
    6.3%
    2
    12.5%
    1
    5.9%
    6
    9.1%
    White
    13
    76.5%
    15
    93.8%
    13
    81.3%
    15
    88.2%
    56
    84.8%
    Other
    0
    0%
    0
    0%
    1
    6.3%
    0
    0%
    1
    1.5%
    Hispanic or Latino
    2
    11.8%
    3
    18.8%
    2
    12.5%
    0
    0%
    7
    10.6%
    Not Hispanic or Latino
    15
    88.2%
    13
    81.3%
    14
    87.5%
    17
    100%
    59
    89.4%
    Region of Enrollment (Count of Participants)
    Belgium
    3
    17.6%
    2
    12.5%
    5
    31.3%
    4
    23.5%
    14
    21.2%
    Ireland
    1
    5.9%
    3
    18.8%
    1
    6.3%
    0
    0%
    5
    7.6%
    United Kingdom
    11
    64.7%
    9
    56.3%
    9
    56.3%
    8
    47.1%
    37
    56.1%
    Spain
    3
    17.6%
    4
    25%
    3
    18.8%
    6
    35.3%
    16
    24.2%
    Actual Glomerular Filtration Rate (mL/min) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mL/min]
    111.8
    (31.07)
    112.0
    (19.17)
    105.4
    (38.22)
    96.6
    (34.52)
    106.4
    (31.52)
    Estimated Glomerular Filtration Rate by Cockcroft-Gault (mL/min) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mL/min]
    120.8
    (13.94)
    121.2
    (24.34)
    119.5
    (20.36)
    122.6
    (20.25)
    121.0
    (19.55)
    Estimated Glomerular Filtration Rate by MDRD Formula (mL/min/1.73m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mL/min/1.73m2]
    103.8
    (14.06)
    110.6
    (18.47)
    108.4
    (21.42)
    105.5
    (12.59)
    107.0
    (16.71)
    CD4 Cell Count (cells/uL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cells/uL]
    552
    (177.8)
    600
    (217.9)
    553
    (215.8)
    524
    (190.0)
    557
    (197.8)

    Outcome Measures

    1. Primary Outcome
    Title Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24
    Description
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 15 15 17
    Mean (Standard Deviation) [mL/min]
    103.6
    (23.28)
    104.9
    (27.16)
    111.1
    (23.23)
    101.0
    (27.01)
    2. Primary Outcome
    Title Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24
    Description GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 15 15 16
    Mean (Standard Deviation) [mL/min]
    116.9
    (17.06)
    122.4
    (31.71)
    120.0
    (20.52)
    123.0
    (25.74)
    3. Primary Outcome
    Title Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24
    Description MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 15 15 16
    Mean (Standard Deviation) [mL/min/1.73m^2]
    99.3
    (17.07)
    110.2
    (23.98)
    109.2
    (20.90)
    104.9
    (12.59)
    4. Secondary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)
    Description
    Time Frame Up to 24 weeks plus 30 days

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 16 17
    Grade 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Grade
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)
    Description
    Time Frame Up to 24 weeks plus 30 days

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15 17
    Grade 1 (Hyperglycemia)
    11.8
    69.4%
    12.5
    78.1%
    20.0
    125%
    0
    0%
    Grade 1 (Hypoglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 2 (Hyperglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 2 (Hypoglycemia)
    0
    0%
    6.3
    39.4%
    0
    0%
    0
    0%
    Grade 3 (Hyperglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 3 (Hypoglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 4 (Hyperglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 4 (Hypoglycemia)
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any grade (Hyperglycemia)
    11.8
    69.4%
    12.5
    78.1%
    20.0
    125%
    0
    0%
    Any grade (Hypoglycemia)
    0
    0%
    6.3
    39.4%
    0
    0%
    0
    0%
    6. Secondary Outcome
    Title Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24
    Description
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 14 13 17
    Median (Inter-Quartile Range) [percentage change]
    0.0
    -18.3
    50.0
    -16.7
    7. Secondary Outcome
    Title Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24
    Description
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 14 15 17
    Median (Inter-Quartile Range) [percentage change]
    5.7
    17.5
    -10.5
    7.1
    8. Secondary Outcome
    Title Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24
    Description
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 14 13 17
    Median (Inter-Quartile Range) [percentage change]
    -5.1
    197.3
    -1.1
    -22.7
    9. Secondary Outcome
    Title Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24
    Description
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the PD Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 14 13 17
    Median (Inter-Quartile Range) [percentage change]
    38.1
    52.2
    52.1
    4.8
    10. Secondary Outcome
    Title Pharmacokinetic (PK) Parameter: Cmax for COBI
    Description Cmax is defined as the maximum observed concentration of drug in plasma.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    1189.1
    (377.88)
    Week 8
    1017.8
    (388.09)
    Week 16
    1197.3
    (656.33)
    Week 24
    1123.4
    (430.41)
    11. Secondary Outcome
    Title PK Parameter: Tmax for COBI
    Description Tmax is defined as the time of Cmax.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    3.3
    Week 8
    3.1
    Week 16
    3.1
    Week 24
    3.0
    12. Secondary Outcome
    Title PK Parameter: Clast for COBI
    Description Clast is defined as the last observable concentration of drug.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    85.0
    (126.69)
    Week 8
    54.5
    (59.58)
    Week 16
    214.0
    (693.66)
    Week 24
    162.7
    (299.48)
    13. Secondary Outcome
    Title PK Parameter: Tlast for COBI
    Description Tlast is defined as the time of Clast. Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    24.0
    Week 8
    24.0
    Week 16
    24.0
    Week 24
    24.0
    14. Secondary Outcome
    Title PK Parameter: Ctau for COBI
    Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    59.7
    (113.31)
    Week 8
    26.0
    (28.79)
    Week 16
    198.3
    (697.06)
    Week 24
    82.7
    (285.81)
    15. Secondary Outcome
    Title PK Parameter: λz for COBI
    Description λz is defined as the terminal elimination rate constant.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16
    Week 4
    0.179
    (0.0598)
    Week 8
    0.192
    (0.0481)
    Week 16
    0.206
    (0.0610)
    Week 24
    0.211
    (0.0844)
    16. Secondary Outcome
    Title PK Parameter: AUCtau for COBI
    Description AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    9225.8
    (2786.60)
    Week 8
    8127.4
    (3217.12)
    Week 16
    10684.8
    (12567.09)
    Week 24
    8391.3
    (6132.50)
    17. Secondary Outcome
    Title PK Parameter: t1/2 for COBI
    Description t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
    Time Frame Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the COBI PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17
    Week 4
    3.80
    Week 8
    4.09
    Week 16
    3.42
    Week 24
    3.24
    18. Secondary Outcome
    Title PK Parameter: Cmax for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    1260.0
    (453.58)
    1352.1
    (513.74)
    Week 8
    1142.3
    (489.18)
    1326.2
    (493.47)
    Week 16
    1144.8
    (416.41)
    1557.6
    (555.87)
    Week 24
    1217.7
    (445.18)
    1485.4
    (662.49)
    19. Secondary Outcome
    Title PK Parameter: Tmax for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    4.0
    4.0
    Week 8
    4.0
    4.0
    Week 16
    4.1
    4.0
    Week 24
    4.0
    4.0
    20. Secondary Outcome
    Title PK Parameter: Clast for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    59.5
    (57.85)
    61.0
    (56.51)
    Week 8
    71.0
    (91.24)
    85.5
    (99.68)
    Week 16
    69.2
    (49.85)
    99.1
    (92.42)
    Week 24
    102.5
    (182.16)
    187.9
    (258.53)
    21. Secondary Outcome
    Title PK Parameter: Tlast for RTV
    Description Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    24.0
    24.0
    Week 8
    24.0
    24.0
    Week 16
    24.0
    24.0
    Week 24
    24.0
    24.0
    22. Secondary Outcome
    Title PK Parameter: Ctau for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    59.5
    (57.85)
    61.0
    (56.51)
    Week 8
    71.0
    (91.24)
    85.5
    (99.68)
    Week 16
    69.2
    (49.85)
    99.1
    (92.42)
    Week 24
    102.5
    (182.16)
    157.0
    (246.75)
    23. Secondary Outcome
    Title PK Parameter: AUCtau for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    8259.6
    (3166.47)
    9649.1
    (3713.87)
    Week 8
    8362.0
    (3544.53)
    9702.2
    (3391.68)
    Week 16
    8102.6
    (3392.00)
    11148.0
    (4482.33)
    Week 24
    8907.0
    (5182.65)
    12039.3
    (6792.06)
    24. Secondary Outcome
    Title PK Parameter: λz for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    0.156
    (0.0386)
    0.151
    (0.0346)
    Week 8
    0.144
    (0.0474)
    0.142
    (0.0281)
    Week 16
    0.138
    (0.0382)
    0.131
    (0.0291)
    Week 24
    0.133
    (0.0347)
    0.128
    (0.0469)
    25. Secondary Outcome
    Title PK Parameter: t1/2 for RTV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    Arm/Group Title TVD + ATV/r + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 17
    Week 4
    4.56
    4.53
    Week 8
    4.85
    4.68
    Week 16
    5.39
    5.57
    Week 24
    5.08
    4.82
    26. Secondary Outcome
    Title PK Parameter: Cmax for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    371.2
    (94.46)
    301.6
    (116.36)
    298.3
    (100.36)
    Week 8
    379.8
    (87.44)
    343.0
    (133.97)
    325.5
    (149.48)
    Week 16
    399.5
    (169.51)
    319.4
    (146.41)
    298.6
    (107.11)
    Week 24
    394.4
    (131.09)
    350.7
    (126.91)
    305.9
    (106.24)
    27. Secondary Outcome
    Title PK Parameter: Tmax for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    2.0
    3.0
    1.1
    Week 8
    2.0
    3.0
    1.0
    Week 16
    2.1
    2.1
    1.2
    Week 24
    2.0
    2.1
    1.1
    28. Secondary Outcome
    Title PK Parameter: Clast for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    81.1
    (32.41)
    73.1
    (23.74)
    55.4
    (15.52)
    Week 8
    80.9
    (35.12)
    78.2
    (31.27)
    53.4
    (18.83)
    Week 16
    128.5
    (184.17)
    74.5
    (26.01)
    63.0
    (19.25)
    Week 24
    78.5
    (53.04)
    87.3
    (41.20)
    58.5
    (16.45)
    29. Secondary Outcome
    Title PK Parameter: Tlast for TFV
    Description Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    24.0
    24.0
    24.0
    Week 8
    24.0
    24.0
    24.0
    Week 16
    24.0
    24.0
    24.0
    Week 24
    24.0
    24.0
    24.0
    30. Secondary Outcome
    Title PK Parameter: Ctau for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    74.6
    (36.88)
    73.1
    (23.74)
    55.4
    (15.52)
    Week 8
    75.8
    (40.16)
    78.2
    (31.27)
    48.8
    (23.27)
    Week 16
    128.5
    (184.17)
    74.5
    (26.01)
    57.5
    (24.41)
    Week 24
    71.7
    (57.06)
    77.3
    (43.06)
    54.2
    (22.17)
    31. Secondary Outcome
    Title PK Parameter: λz for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    0.045
    (0.0148)
    0.048
    (0.0059)
    0.037
    (0.0133)
    Week 8
    0.051
    (0.0167)
    0.048
    (0.0158)
    0.041
    (0.0197)
    Week 16
    0.047
    (0.0173)
    0.047
    (0.0115)
    0.033
    (0.0166)
    Week 24
    0.051
    (0.0195)
    0.046
    (0.0184)
    0.035
    (0.0138)
    32. Secondary Outcome
    Title PK Parameter: AUCtau for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    3370.2
    (1000.75)
    3151.2
    (1107.18)
    2244.8
    (572.09)
    Week 8
    3549.7
    (1238.03)
    3361.9
    (1152.04)
    2250.8
    (555.79)
    Week 16
    3939.7
    (2499.63)
    3234.7
    (1207.58)
    2326.4
    (494.24)
    Week 24
    3307.0
    (1387.97)
    3451.5
    (1075.47)
    2265.7
    (412.87)
    33. Secondary Outcome
    Title PK Parameter: t1/2 for TFV
    Description
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 15
    Week 4
    15.73
    14.10
    20.65
    Week 8
    14.40
    15.82
    18.81
    Week 16
    14.41
    14.72
    22.78
    Week 24
    13.99
    16.17
    21.54
    34. Secondary Outcome
    Title PK Parameter: AUCinf for Iohexol
    Description AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
    Time Frame Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Day 1 and Weeks 4, 8, 16, and 24

    Outcome Measure Data

    Analysis Population Description
    Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 16 17
    Day 1
    511.2
    (172.71)
    486.8
    (108.28)
    706.9
    (647.25)
    695.2
    (523.33)
    Week 4
    521.8
    (121.67)
    496.2
    (153.05)
    512.6
    (163.89)
    720.5
    (657.95)
    Week 8
    517.8
    (170.24)
    574.8
    (382.63)
    510.6
    (136.40)
    667.0
    (559.06)
    Week 16
    494.3
    (113.60)
    509.5
    (156.98)
    504.8
    (95.07)
    725.9
    (843.22)
    Week 24
    545.8
    (127.34)
    561.2
    (214.26)
    507.1
    (113.45)
    606.5
    (321.40)
    35. Secondary Outcome
    Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm
    Description
    Time Frame Week 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 13 15
    Number [percentage of participants]
    88.2
    518.8%
    81.3
    508.1%
    81.3
    508.1%
    88.2
    518.8%
    36. Secondary Outcome
    Title Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24
    Description
    Time Frame Baseline; Week 24

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 16 15 15 17
    Mean (Standard Deviation) [cells/uL]
    139.63
    (142.196)
    217.60
    (195.375)
    204.33
    (194.653)
    237.29
    (201.222)
    37. Secondary Outcome
    Title Percentage of Participants Experiencing Adverse Events (AEs)
    Description Incidences of adverse events and laboratory abnormalities will be summarized.
    Time Frame Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 16 17
    Any Treatment-Emergent Adverse Events (TEAE)
    70.6
    415.3%
    87.5
    546.9%
    87.5
    546.9%
    88.2
    518.8%
    Any Grade 3 or 4 Treatment-Emergent Adverse Event
    5.9
    34.7%
    12.5
    78.1%
    12.5
    78.1%
    5.9
    34.7%
    Any Treatment-Emergent Study-Drug-Related AEs
    11.8
    69.4%
    50.0
    312.5%
    68.8
    430%
    23.5
    138.2%
    Any TEAE Leading to Study Drug Discontinuation
    5.9
    34.7%
    6.3
    39.4%
    6.3
    39.4%
    0
    0%
    38. Secondary Outcome
    Title Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities
    Description Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.
    Time Frame Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Measure Participants 17 16 16 17
    Any Grade 3 or 4 TE Laboratory Abnormality
    5.9
    34.7%
    25.0
    156.3%
    12.5
    78.1%
    52.9
    311.2%
    Grade 3 or 4 Neutrophils
    0
    0%
    6.3
    39.4%
    0
    0%
    0
    0%
    Grade 3 or 4 Amylase
    0
    0%
    0
    0%
    6.3
    39.4%
    0
    0%
    Grade 3 or 4 AST
    0
    0%
    6.3
    39.4%
    0
    0%
    0
    0%
    Grade 3 or 4 CK
    5.9
    34.7%
    18.8
    117.5%
    6.3
    39.4%
    5.9
    34.7%
    Grade 3 or 4 Total Bilirubin
    0
    0%
    12.5
    78.1%
    0
    0%
    52.9
    311.2%
    Grade 3 or 4 Urine RBC
    0
    0%
    7.7
    48.1%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days)
    Adverse Event Reporting Description Safety Analysis Set
    Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Arm/Group Description STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    All Cause Mortality
    STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    Serious Adverse Events
    STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/17 (5.9%) 1/16 (6.3%) 1/16 (6.3%) 2/17 (11.8%)
    Hepatobiliary disorders
    LIVER INJURY 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Infections and infestations
    ANAL ABSCESS 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    PNEUMONIA BACTERIAL 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    Injury, poisoning and procedural complications
    OVERDOSE 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    UPPER LIMB FRACTURE 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    Psychiatric disorders
    INTENTIONAL SELF-INJURY 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    Renal and urinary disorders
    ACUTE KIDNEY INJURY 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Other (Not Including Serious) Adverse Events
    STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/17 (64.7%) 14/16 (87.5%) 13/16 (81.3%) 14/17 (82.4%)
    Blood and lymphatic system disorders
    ANAEMIA 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    Eye disorders
    EYE PAIN 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    OCULAR ICTERUS 0/17 (0%) 3/16 (18.8%) 0/16 (0%) 1/17 (5.9%)
    Gastrointestinal disorders
    ANAL FISSURE 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    CONSTIPATION 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    DIARRHOEA 3/17 (17.6%) 5/16 (31.3%) 2/16 (12.5%) 4/17 (23.5%)
    DIARRHOEA HAEMORRHAGIC 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    DRY MOUTH 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    DYSPEPSIA 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 1/17 (5.9%)
    FLATULENCE 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    HAEMORRHOIDS 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    NAUSEA 1/17 (5.9%) 2/16 (12.5%) 0/16 (0%) 1/17 (5.9%)
    TOOTHACHE 0/17 (0%) 0/16 (0%) 2/16 (12.5%) 1/17 (5.9%)
    VOMITING 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    General disorders
    ASTHENIA 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    FATIGUE 2/17 (11.8%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    INFLUENZA LIKE ILLNESS 0/17 (0%) 1/16 (6.3%) 1/16 (6.3%) 1/17 (5.9%)
    PAIN 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    PYREXIA 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Hepatobiliary disorders
    JAUNDICE 0/17 (0%) 2/16 (12.5%) 0/16 (0%) 1/17 (5.9%)
    Immune system disorders
    SEASONAL ALLERGY 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    Infections and infestations
    ACUTE HEPATITIS C 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    ANAL CHLAMYDIA INFECTION 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    CYSTITIS 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    EAR INFECTION 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    EYE ABSCESS 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    EYELID BOIL 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    FUNGAL SKIN INFECTION 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    FURUNCLE 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    GASTROENTERITIS 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    GONORRHOEA 0/17 (0%) 3/16 (18.8%) 1/16 (6.3%) 1/17 (5.9%)
    LARYNGITIS 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    NASOPHARYNGITIS 1/17 (5.9%) 3/16 (18.8%) 3/16 (18.8%) 2/17 (11.8%)
    ONYCHOMYCOSIS 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    OTITIS EXTERNA 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    RESPIRATORY TRACT INFECTION 1/17 (5.9%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    SYPHILIS 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    TINEA CRURIS 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    TINEA PEDIS 2/17 (11.8%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    TINEA VERSICOLOUR 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    UPPER RESPIRATORY TRACT INFECTION 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 1/17 (5.9%)
    Injury, poisoning and procedural complications
    PROCEDURAL PAIN 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    TRAUMATIC HAEMATOMA 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED 0/17 (0%) 2/16 (12.5%) 0/16 (0%) 0/17 (0%)
    LIVER FUNCTION TEST ABNORMAL 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Metabolism and nutrition disorders
    INCREASED APPETITE 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    NECK PAIN 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ANOGENITAL WARTS 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    Nervous system disorders
    DIZZINESS 0/17 (0%) 1/16 (6.3%) 7/16 (43.8%) 0/17 (0%)
    HEAD DISCOMFORT 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    HEADACHE 2/17 (11.8%) 1/16 (6.3%) 2/16 (12.5%) 3/17 (17.6%)
    HYPOAESTHESIA 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    LETHARGY 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    NERVOUS SYSTEM DISORDER 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    Psychiatric disorders
    ABNORMAL BEHAVIOUR 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    ABNORMAL DREAMS 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    DEPRESSED MOOD 0/17 (0%) 1/16 (6.3%) 1/16 (6.3%) 0/17 (0%)
    DISORIENTATION 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    INDIFFERENCE 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    INSOMNIA 1/17 (5.9%) 0/16 (0%) 1/16 (6.3%) 2/17 (11.8%)
    NIGHTMARE 0/17 (0%) 0/16 (0%) 2/16 (12.5%) 0/17 (0%)
    SLEEP DISORDER 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    TERMINAL INSOMNIA 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    Respiratory, thoracic and mediastinal disorders
    CATARRH 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    COUGH 1/17 (5.9%) 0/16 (0%) 2/16 (12.5%) 0/17 (0%)
    NASAL CONGESTION 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 1/17 (5.9%)
    OROPHARYNGEAL PAIN 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    Skin and subcutaneous tissue disorders
    DERMATITIS ALLERGIC 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    ERYTHEMA 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    INGROWING NAIL 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    PRURITUS 0/17 (0%) 0/16 (0%) 0/16 (0%) 1/17 (5.9%)
    RASH 0/17 (0%) 2/16 (12.5%) 2/16 (12.5%) 0/17 (0%)
    RASH ERYTHEMATOUS 1/17 (5.9%) 0/16 (0%) 0/16 (0%) 0/17 (0%)
    Vascular disorders
    HAEMATOMA 1/17 (5.9%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    HOT FLUSH 0/17 (0%) 0/16 (0%) 1/16 (6.3%) 0/17 (0%)
    HYPOTENSION 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)
    SPIDER VEIN 0/17 (0%) 1/16 (6.3%) 0/16 (0%) 0/17 (0%)

    Limitations/Caveats

    There were no limitations affecting the analysis or results.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02246998
    Other Study ID Numbers:
    • GS-US-236-0140
    • 2014-002095-93
    First Posted:
    Sep 23, 2014
    Last Update Posted:
    Jan 3, 2018
    Last Verified:
    Dec 1, 2017