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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

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ClinicalTrials.gov Identifier: NCT02246998
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: STB
Drug: TVD
Drug: ATR
Drug: RTV
Drug: ATV
Drug: ABC/3TC
Drug: Iohexol
Enrollment 72
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 Details 93 participants were screened.
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Hide 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
Reason Not Completed
Adverse Event             0             1             1             0
Lost to Follow-up             1             0             0             1
Randomized but Never Dosed             1             2             2             1
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol Total
Hide 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 Number of Baseline Participants 17 16 16 17 66
Hide Baseline Analysis Population Description
Safety Analysis Set: all randomized participants who received at least 1 dose of study drug, excluding iohexol
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
36  (8.1) 34  (8.4) 34  (9.6) 34  (7.5) 35  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
Female
0
   0.0%
1
   6.3%
1
   6.3%
0
   0.0%
2
   3.0%
Male
17
 100.0%
15
  93.8%
15
  93.8%
17
 100.0%
64
  97.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
American Indian or Alaska Native
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
Asian
1
   5.9%
0
   0.0%
0
   0.0%
1
   5.9%
2
   3.0%
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
   0.0%
1
   6.3%
0
   0.0%
1
   1.5%
Hispanic or Latino
2
  11.8%
3
  18.8%
2
  12.5%
0
   0.0%
7
  10.6%
Not Hispanic or Latino
15
  88.2%
13
  81.3%
14
  87.5%
17
 100.0%
59
  89.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 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
   0.0%
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
  25.0%
3
  18.8%
6
  35.3%
16
  24.2%
Actual Glomerular Filtration Rate  
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
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  
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
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  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m2
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
103.8  (14.06) 110.6  (18.47) 108.4  (21.42) 105.5  (12.59) 107.0  (16.71)
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 17 participants 16 participants 16 participants 17 participants 66 participants
552  (177.8) 600  (217.9) 553  (215.8) 524  (190.0) 557  (197.8)
1.Primary Outcome
Title Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 15 15 17
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 15 15 16
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 15 15 16
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Description [Not Specified]
Time Frame Up to 24 weeks plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Hide 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
Overall Number of Participants Analyzed 17 16 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Grade
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)
Hide Description [Not Specified]
Time Frame Up to 24 weeks plus 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15 17
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 (Hyperglycemia) 11.8 12.5 20.0 0
Grade 1 (Hypoglycemia) 0 0 0 0
Grade 2 (Hyperglycemia) 0 0 0 0
Grade 2 (Hypoglycemia) 0 6.3 0 0
Grade 3 (Hyperglycemia) 0 0 0 0
Grade 3 (Hypoglycemia) 0 0 0 0
Grade 4 (Hyperglycemia) 0 0 0 0
Grade 4 (Hypoglycemia) 0 0 0 0
Any grade (Hyperglycemia) 11.8 12.5 20.0 0
Any grade (Hypoglycemia) 0 6.3 0 0
6.Secondary Outcome
Title Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 14 13 17
Median (Inter-Quartile Range)
Unit of Measure: percentage change
0.0
(-23.6 to 50.0)
-18.3
(-57.1 to 50.0)
50.0
(-25.0 to 100.0)
-16.7
(-37.5 to 0.0)
7.Secondary Outcome
Title Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 14 15 17
Median (Inter-Quartile Range)
Unit of Measure: percentage change
5.7
(-11.0 to 22.5)
17.5
(0.0 to 45.7)
-10.5
(-41.9 to 69.8)
7.1
(-24.3 to 13.3)
8.Secondary Outcome
Title Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 14 13 17
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-5.1
(-48.2 to 22.8)
197.3
(21.7 to 328.7)
-1.1
(-33.1 to 36.7)
-22.7
(-60.8 to -6.0)
9.Secondary Outcome
Title Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 14 13 17
Median (Inter-Quartile Range)
Unit of Measure: percentage change
38.1
(-1.1 to 51.1)
52.2
(5.9 to 147.6)
52.1
(-33.8 to 92.8)
4.8
(-13.6 to 15.5)
10.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants
1189.1  (377.88)
Week 8 Number Analyzed 17 participants
1017.8  (388.09)
Week 16 Number Analyzed 17 participants
1197.3  (656.33)
Week 24 Number Analyzed 16 participants
1123.4  (430.41)
11.Secondary Outcome
Title PK Parameter: Tmax for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 17 participants
3.3
(3.0 to 4.1)
Week 8 Number Analyzed 17 participants
3.1
(3.0 to 4.1)
Week 16 Number Analyzed 17 participants
3.1
(2.1 to 4.0)
Week 24 Number Analyzed 16 participants
3.0
(2.1 to 4.0)
12.Secondary Outcome
Title PK Parameter: Clast for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants
85.0  (126.69)
Week 8 Number Analyzed 17 participants
54.5  (59.58)
Week 16 Number Analyzed 17 participants
214.0  (693.66)
Week 24 Number Analyzed 16 participants
162.7  (299.48)
13.Secondary Outcome
Title PK Parameter: Tlast for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 17 participants
24.0
(24.0 to 24.0)
Week 8 Number Analyzed 17 participants
24.0
(24.0 to 24.0)
Week 16 Number Analyzed 17 participants
24.0
(24.0 to 24.0)
Week 24 Number Analyzed 16 participants
24.0
(10.1 to 24.0)
14.Secondary Outcome
Title PK Parameter: Ctau for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: 1/hour
Week 4 Number Analyzed 16 participants
0.179  (0.0598)
Week 8 Number Analyzed 15 participants
0.192  (0.0481)
Week 16 Number Analyzed 16 participants
0.206  (0.0610)
Week 24 Number Analyzed 15 participants
0.211  (0.0844)
16.Secondary Outcome
Title PK Parameter: AUCtau for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Week 4 Number Analyzed 16 participants
9225.8  (2786.60)
Week 8 Number Analyzed 15 participants
8127.4  (3217.12)
Week 16 Number Analyzed 17 participants
10684.8  (12567.09)
Week 24 Number Analyzed 15 participants
8391.3  (6132.50)
17.Secondary Outcome
Title PK Parameter: t1/2 for COBI
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the COBI PK Analysis Set with available data were analyzed.
Arm/Group Title STB + Iohexol
Hide 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
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 16 participants
3.80
(3.24 to 4.63)
Week 8 Number Analyzed 15 participants
4.09
(2.89 to 4.75)
Week 16 Number Analyzed 16 participants
3.42
(2.91 to 4.18)
Week 24 Number Analyzed 15 participants
3.24
(2.57 to 4.39)
18.Secondary Outcome
Title PK Parameter: Cmax for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 16 participants 17 participants
1260.0  (453.58) 1352.1  (513.74)
Week 8 Number Analyzed 16 participants 17 participants
1142.3  (489.18) 1326.2  (493.47)
Week 16 Number Analyzed 15 participants 17 participants
1144.8  (416.41) 1557.6  (555.87)
Week 24 Number Analyzed 15 participants 17 participants
1217.7  (445.18) 1485.4  (662.49)
19.Secondary Outcome
Title PK Parameter: Tmax for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 16 participants 17 participants
4.0
(3.2 to 4.6)
4.0
(2.1 to 4.1)
Week 8 Number Analyzed 16 participants 17 participants
4.0
(2.5 to 5.1)
4.0
(3.0 to 4.1)
Week 16 Number Analyzed 15 participants 17 participants
4.1
(3.0 to 5.1)
4.0
(2.2 to 4.1)
Week 24 Number Analyzed 15 participants 17 participants
4.0
(3.0 to 5.0)
4.0
(3.0 to 4.1)
20.Secondary Outcome
Title PK Parameter: Clast for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 16 participants 17 participants
59.5  (57.85) 61.0  (56.51)
Week 8 Number Analyzed 16 participants 17 participants
71.0  (91.24) 85.5  (99.68)
Week 16 Number Analyzed 15 participants 17 participants
69.2  (49.85) 99.1  (92.42)
Week 24 Number Analyzed 15 participants 17 participants
102.5  (182.16) 187.9  (258.53)
21.Secondary Outcome
Title PK Parameter: Tlast for RTV
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 16 participants 17 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 8 Number Analyzed 16 participants 17 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 16 Number Analyzed 15 participants 17 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 24 Number Analyzed 15 participants 17 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
22.Secondary Outcome
Title PK Parameter: Ctau for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 16 participants 17 participants
59.5  (57.85) 61.0  (56.51)
Week 8 Number Analyzed 16 participants 17 participants
71.0  (91.24) 85.5  (99.68)
Week 16 Number Analyzed 15 participants 17 participants
69.2  (49.85) 99.1  (92.42)
Week 24 Number Analyzed 15 participants 17 participants
102.5  (182.16) 157.0  (246.75)
23.Secondary Outcome
Title PK Parameter: AUCtau for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Week 4 Number Analyzed 16 participants 17 participants
8259.6  (3166.47) 9649.1  (3713.87)
Week 8 Number Analyzed 16 participants 17 participants
8362.0  (3544.53) 9702.2  (3391.68)
Week 16 Number Analyzed 15 participants 17 participants
8102.6  (3392.00) 11148.0  (4482.33)
Week 24 Number Analyzed 15 participants 16 participants
8907.0  (5182.65) 12039.3  (6792.06)
24.Secondary Outcome
Title PK Parameter: λz for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: 1/hour
Week 4 Number Analyzed 14 participants 15 participants
0.156  (0.0386) 0.151  (0.0346)
Week 8 Number Analyzed 13 participants 15 participants
0.144  (0.0474) 0.142  (0.0281)
Week 16 Number Analyzed 12 participants 17 participants
0.138  (0.0382) 0.131  (0.0291)
Week 24 Number Analyzed 15 participants 15 participants
0.133  (0.0347) 0.128  (0.0469)
25.Secondary Outcome
Title PK Parameter: t1/2 for RTV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 16 17
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 14 participants 15 participants
4.56
(3.77 to 4.99)
4.53
(3.83 to 6.01)
Week 8 Number Analyzed 13 participants 15 participants
4.85
(3.75 to 5.34)
4.68
(4.31 to 5.69)
Week 16 Number Analyzed 12 participants 17 participants
5.39
(4.22 to 6.22)
5.57
(4.68 to 6.00)
Week 24 Number Analyzed 15 participants 15 participants
5.08
(4.49 to 5.78)
4.82
(4.25 to 6.41)
26.Secondary Outcome
Title PK Parameter: Cmax for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants 16 participants 15 participants
371.2  (94.46) 301.6  (116.36) 298.3  (100.36)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
379.8  (87.44) 343.0  (133.97) 325.5  (149.48)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
399.5  (169.51) 319.4  (146.41) 298.6  (107.11)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
394.4  (131.09) 350.7  (126.91) 305.9  (106.24)
27.Secondary Outcome
Title PK Parameter: Tmax for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 17 participants 16 participants 15 participants
2.0
(1.3 to 3.1)
3.0
(1.5 to 3.1)
1.1
(0.6 to 2.0)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
2.0
(2.0 to 2.1)
3.0
(2.0 to 3.1)
1.0
(0.6 to 1.1)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
2.1
(1.1 to 3.1)
2.1
(1.0 to 3.1)
1.2
(1.0 to 2.1)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
2.0
(1.1 to 3.0)
2.1
(1.1 to 3.2)
1.1
(0.6 to 2.0)
28.Secondary Outcome
Title PK Parameter: Clast for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants 16 participants 15 participants
81.1  (32.41) 73.1  (23.74) 55.4  (15.52)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
80.9  (35.12) 78.2  (31.27) 53.4  (18.83)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
128.5  (184.17) 74.5  (26.01) 63.0  (19.25)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
78.5  (53.04) 87.3  (41.20) 58.5  (16.45)
29.Secondary Outcome
Title PK Parameter: Tlast for TFV
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 17 participants 16 participants 15 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
24.0
(24.0 to 24.0)
30.Secondary Outcome
Title PK Parameter: Ctau for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants 16 participants 15 participants
74.6  (36.88) 73.1  (23.74) 55.4  (15.52)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
75.8  (40.16) 78.2  (31.27) 48.8  (23.27)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
128.5  (184.17) 74.5  (26.01) 57.5  (24.41)
Week 24 Number Analyzed 17 participants 15 participants 15 participants
71.7  (57.06) 77.3  (43.06) 54.2  (22.17)
31.Secondary Outcome
Title PK Parameter: λz for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: 1/hour
Week 4 Number Analyzed 17 participants 15 participants 15 participants
0.045  (0.0148) 0.048  (0.0059) 0.037  (0.0133)
Week 8 Number Analyzed 17 participants 15 participants 13 participants
0.051  (0.0167) 0.048  (0.0158) 0.041  (0.0197)
Week 16 Number Analyzed 16 participants 14 participants 15 participants
0.047  (0.0173) 0.047  (0.0115) 0.033  (0.0166)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
0.051  (0.0195) 0.046  (0.0184) 0.035  (0.0138)
32.Secondary Outcome
Title PK Parameter: AUCtau for TFV
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Week 4 Number Analyzed 17 participants 16 participants 15 participants
3370.2  (1000.75) 3151.2  (1107.18) 2244.8  (572.09)
Week 8 Number Analyzed 17 participants 16 participants 14 participants
3549.7  (1238.03) 3361.9  (1152.04) 2250.8  (555.79)
Week 16 Number Analyzed 17 participants 15 participants 15 participants
3939.7  (2499.63) 3234.7  (1207.58) 2326.4  (494.24)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
3307.0  (1387.97) 3451.5  (1075.47) 2265.7  (412.87)
33.Secondary Outcome
Title PK Parameter: t1/2 for TFV
Hide Description [Not Specified]
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
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Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 15
Median (Inter-Quartile Range)
Unit of Measure: hours
Week 4 Number Analyzed 17 participants 15 participants 15 participants
15.73
(12.49 to 18.90)
14.10
(13.28 to 16.81)
20.65
(15.30 to 26.75)
Week 8 Number Analyzed 17 participants 16 participants 13 participants
14.40
(12.07 to 16.83)
15.82
(11.94 to 19.53)
18.81
(13.08 to 25.14)
Week 16 Number Analyzed 16 participants 14 participants 15 participants
14.41
(13.11 to 19.87)
14.72
(12.76 to 16.73)
22.78
(16.88 to 32.15)
Week 24 Number Analyzed 16 participants 15 participants 15 participants
13.99
(11.91 to 18.52)
16.17
(13.18 to 21.37)
21.54
(19.39 to 27.32)
34.Secondary Outcome
Title PK Parameter: AUCinf for Iohexol
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 16 17
Mean (Standard Deviation)
Unit of Measure: h*µg/mL
Day 1 Number Analyzed 17 participants 16 participants 16 participants 17 participants
511.2  (172.71) 486.8  (108.28) 706.9  (647.25) 695.2  (523.33)
Week 4 Number Analyzed 17 participants 16 participants 14 participants 17 participants
521.8  (121.67) 496.2  (153.05) 512.6  (163.89) 720.5  (657.95)
Week 8 Number Analyzed 17 participants 16 participants 15 participants 16 participants
517.8  (170.24) 574.8  (382.63) 510.6  (136.40) 667.0  (559.06)
Week 16 Number Analyzed 17 participants 15 participants 15 participants 17 participants
494.3  (113.60) 509.5  (156.98) 504.8  (95.07) 725.9  (843.22)
Week 24 Number Analyzed 17 participants 15 participants 15 participants 17 participants
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
Hide Description [Not Specified]
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 17 16 13 15
Measure Type: Number
Unit of Measure: percentage of participants
88.2 81.3 81.3 88.2
36.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
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Full Analysis Set
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Hide 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
Overall Number of Participants Analyzed 16 15 15 17
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Hide 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
Overall Number of Participants Analyzed 17 16 16 17
Measure Type: Number
Unit of Measure: Percentage of participants
Any Treatment-Emergent Adverse Events (TEAE) 70.6 87.5 87.5 88.2
Any Grade 3 or 4 Treatment-Emergent Adverse Event 5.9 12.5 12.5 5.9
Any Treatment-Emergent Study-Drug-Related AEs 11.8 50.0 68.8 23.5
Any TEAE Leading to Study Drug Discontinuation 5.9 6.3 6.3 0
38.Secondary Outcome
Title Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities
Hide 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)
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Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Hide 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
Overall Number of Participants Analyzed 17 16 16 17
Measure Type: Number
Unit of Measure: Percentage of participants
Any Grade 3 or 4 TE Laboratory Abnormality 5.9 25.0 12.5 52.9
Grade 3 or 4 Neutrophils 0 6.3 0 0
Grade 3 or 4 Amylase 0 0 6.3 0
Grade 3 or 4 AST 0 6.3 0 0
Grade 3 or 4 CK 5.9 18.8 6.3 5.9
Grade 3 or 4 Total Bilirubin 0 12.5 0 52.9
Grade 3 or 4 Urine RBC 0 7.7 0 0
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/17 (5.88%)   1/16 (6.25%)   1/16 (6.25%)   2/17 (11.76%) 
Hepatobiliary disorders         
LIVER INJURY  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
Infections and infestations         
ANAL ABSCESS  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
PNEUMONIA BACTERIAL  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Injury, poisoning and procedural complications         
OVERDOSE  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
UPPER LIMB FRACTURE  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
Psychiatric disorders         
INTENTIONAL SELF-INJURY  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders         
ACUTE KIDNEY INJURY  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
STB + Iohexol TVD + ATV/r + Iohexol ATR + Iohexol ABC/3TC + ATV/r + Iohexol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/17 (64.71%)   14/16 (87.50%)   13/16 (81.25%)   14/17 (82.35%) 
Blood and lymphatic system disorders         
ANAEMIA  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Eye disorders         
EYE PAIN  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
OCULAR ICTERUS  1  0/17 (0.00%)  3/16 (18.75%)  0/16 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders         
ANAL FISSURE  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
CONSTIPATION  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
DIARRHOEA  1  3/17 (17.65%)  5/16 (31.25%)  2/16 (12.50%)  4/17 (23.53%) 
DIARRHOEA HAEMORRHAGIC  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
DRY MOUTH  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
DYSPEPSIA  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  1/17 (5.88%) 
FLATULENCE  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
HAEMORRHOIDS  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
NAUSEA  1  1/17 (5.88%)  2/16 (12.50%)  0/16 (0.00%)  1/17 (5.88%) 
TOOTHACHE  1  0/17 (0.00%)  0/16 (0.00%)  2/16 (12.50%)  1/17 (5.88%) 
VOMITING  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
General disorders         
ASTHENIA  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
FATIGUE  1  2/17 (11.76%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/17 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  1/17 (5.88%) 
PAIN  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
PYREXIA  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
Hepatobiliary disorders         
JAUNDICE  1  0/17 (0.00%)  2/16 (12.50%)  0/16 (0.00%)  1/17 (5.88%) 
Immune system disorders         
SEASONAL ALLERGY  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Infections and infestations         
ACUTE HEPATITIS C  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
ANAL CHLAMYDIA INFECTION  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
CYSTITIS  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
EAR INFECTION  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
EYE ABSCESS  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
EYELID BOIL  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
FUNGAL SKIN INFECTION  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
FURUNCLE  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
GASTROENTERITIS  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
GONORRHOEA  1  0/17 (0.00%)  3/16 (18.75%)  1/16 (6.25%)  1/17 (5.88%) 
LARYNGITIS  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
NASOPHARYNGITIS  1  1/17 (5.88%)  3/16 (18.75%)  3/16 (18.75%)  2/17 (11.76%) 
ONYCHOMYCOSIS  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
OTITIS EXTERNA  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/17 (5.88%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
SYPHILIS  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
TINEA CRURIS  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
TINEA PEDIS  1  2/17 (11.76%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
TINEA VERSICOLOUR  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications         
PROCEDURAL PAIN  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
TRAUMATIC HAEMATOMA  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
Investigations         
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  0/17 (0.00%)  2/16 (12.50%)  0/16 (0.00%)  0/17 (0.00%) 
LIVER FUNCTION TEST ABNORMAL  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
Metabolism and nutrition disorders         
INCREASED APPETITE  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
NECK PAIN  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
ANOGENITAL WARTS  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Nervous system disorders         
DIZZINESS  1  0/17 (0.00%)  1/16 (6.25%)  7/16 (43.75%)  0/17 (0.00%) 
HEAD DISCOMFORT  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
HEADACHE  1  2/17 (11.76%)  1/16 (6.25%)  2/16 (12.50%)  3/17 (17.65%) 
HYPOAESTHESIA  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
LETHARGY  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
NERVOUS SYSTEM DISORDER  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Psychiatric disorders         
ABNORMAL BEHAVIOUR  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
ABNORMAL DREAMS  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
DEPRESSED MOOD  1  0/17 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/17 (0.00%) 
DISORIENTATION  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
INDIFFERENCE  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
INSOMNIA  1  1/17 (5.88%)  0/16 (0.00%)  1/16 (6.25%)  2/17 (11.76%) 
NIGHTMARE  1  0/17 (0.00%)  0/16 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
SLEEP DISORDER  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
TERMINAL INSOMNIA  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
CATARRH  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
COUGH  1  1/17 (5.88%)  0/16 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
NASAL CONGESTION  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  1/17 (5.88%) 
OROPHARYNGEAL PAIN  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders         
DERMATITIS ALLERGIC  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
ERYTHEMA  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
INGROWING NAIL  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
PRURITUS  1  0/17 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
RASH  1  0/17 (0.00%)  2/16 (12.50%)  2/16 (12.50%)  0/17 (0.00%) 
RASH ERYTHEMATOUS  1  1/17 (5.88%)  0/16 (0.00%)  0/16 (0.00%)  0/17 (0.00%) 
Vascular disorders         
HAEMATOMA  1  1/17 (5.88%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
HOT FLUSH  1  0/17 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
HYPOTENSION  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
SPIDER VEIN  1  0/17 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
There were no limitations affecting the analysis or results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02246998     History of Changes
Other Study ID Numbers: GS-US-236-0140
2014-002095-93 ( EudraCT Number )
First Submitted: September 19, 2014
First Posted: September 23, 2014
Results First Submitted: January 20, 2017
Results First Posted: January 3, 2018
Last Update Posted: January 3, 2018