Trial Outcomes & Findings for A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients (NCT NCT00827112)
NCT ID: NCT00827112
Last Updated: 2012-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Week 48
Results posted on
2012-06-15
Participant Flow
Participant milestones
| Measure |
Maraviroc+ Atazanavir / Ritonavir
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
|
Overall Study
Treated
|
60
|
61
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
| Measure |
Maraviroc+ Atazanavir / Ritonavir
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Randomized but not treated
|
5
|
3
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Baseline characteristics by cohort
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=60 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.3 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
35.3 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
36.8 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
|
74.60 Percentage of participants
Interval 63.47 to 85.69
|
83.60 Percentage of participants
Interval 74.32 to 92.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
HIV-1 RNA Levels at Baseline
|
84982 copies/mL
Standard Deviation 127008
|
114827 copies/mL
Standard Deviation 149638
|
SECONDARY outcome
Timeframe: Baseline , Days 4, 7, 10 and 14Population: First 15 participants who were enrolled at U.S sites and had taken the study drug .
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=14 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=16 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Change at Day 4
|
1800.00 copies/mL
Standard Deviation 37351.09
|
-46479.40 copies/mL
Standard Deviation 62259.15
|
|
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Change at Day 7
|
-36947.90 copies/mL
Standard Deviation 28463.80
|
-52137.10 copies/mL
Standard Deviation 68684.14
|
|
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Change at Day 10
|
-58595.80 copies/mL
Standard Deviation 66157.66
|
-54925.90 copies/mL
Standard Deviation 70846.93
|
|
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Change at Day 14
|
-47271.60 copies/mL
Standard Deviation 38234.34
|
-55449.90 copies/mL
Standard Deviation 71207.16
|
SECONDARY outcome
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)Population: Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=15 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Maraviroc
|
650 nanogram (ng)/mL
Interval 178.0 to 1490.0
|
—
|
SECONDARY outcome
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)Population: PK parameter analysis population included first 15 participants treated with maraviroc.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=15 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of Maraviroc
|
37.0 ng/mL
Interval 8.4 to 92.7
|
—
|
SECONDARY outcome
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)Population: PK parameter analysis population included first 15 participants treated with maraviroc.
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=15 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Average Observed Plasma Concentration (Cavg) of Maraviroc
|
185.10 ng/mL
Standard Deviation 71.08
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Baseline (n= 59, 61)
|
84982 log10 copies/ml
Standard Deviation 127008
|
114827 log10 copies/ml
Standard Deviation 149638
|
|
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Change at Week 16 (n= 54, 58)
|
-89859.1 log10 copies/ml
Standard Deviation 131317.35
|
-107684.6 log10 copies/ml
Standard Deviation 149476.47
|
|
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Change at Week 24 (n= 56, 58)
|
-87241.2 log10 copies/ml
Standard Deviation 129638.57
|
-110498.1 log10 copies/ml
Standard Deviation 149836.29
|
|
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Change at Week 48 (n= 53, 54)
|
-82343.4 log10 copies/ml
Standard Deviation 119356.62
|
-115582.9 log10 copies/ml
Standard Deviation 153705.26
|
|
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Change at Week 96 (n= 49, 51)
|
-80117.7 log10 copies/ml
Standard Deviation 121443.50
|
-99662.6 log10 copies/ml
Standard Deviation 116525.87
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 2 (n= 55, 60)
|
0 Percentage of participants
Interval 0.0 to 0.0
|
6.60 Percentage of participants
Interval 0.35 to 12.77
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 4 (n= 57, 60)
|
8.50 Percentage of participants
Interval 1.37 to 15.58
|
21.30 Percentage of participants
Interval 11.03 to 31.59
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 8 (n= 57, 59)
|
47.50 Percentage of participants
Interval 34.72 to 60.2
|
42.60 Percentage of participants
Interval 30.21 to 55.03
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 12 (n= 55, 59)
|
61.00 Percentage of participants
Interval 48.57 to 73.46
|
62.30 Percentage of participants
Interval 50.13 to 74.46
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 16 (n= 54, 58)
|
72.90 Percentage of participants
Interval 61.54 to 84.23
|
73.80 Percentage of participants
Interval 62.73 to 84.81
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 20 (n= 56, 57)
|
71.20 Percentage of participants
Interval 59.63 to 82.74
|
83.61 Percentage of participants
Interval 74.32 to 92.9
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 24 (n= 56, 58)
|
81.36 Percentage of participants
Interval 71.42 to 91.29
|
88.52 Percentage of participants
Interval 80.53 to 96.52
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 32 (n= 55, 57)
|
79.66 Percentage of participants
Interval 69.39 to 89.93
|
88.52 Percentage of participants
Interval 80.53 to 96.52
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 40 (n= 54, 55)
|
81.36 Percentage of participants
Interval 71.42 to 91.29
|
88.52 Percentage of participants
Interval 80.53 to 96.52
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 48 (n= 53, 54)
|
74.58 Percentage of participants
Interval 63.47 to 85.69
|
83.61 Percentage of participants
Interval 74.32 to 92.9
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 60 (n= 52, 53)
|
67.80 Percentage of participants
Interval 55.87 to 79.72
|
85.25 Percentage of participants
Interval 76.35 to 94.15
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 72 (n= 52, 53)
|
74.58 Percentage of participants
Interval 63.47 to 85.69
|
81.97 Percentage of participants
Interval 72.32 to 91.62
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 84 (n= 50, 52)
|
76.27 Percentage of participants
Interval 65.42 to 87.13
|
83.61 Percentage of participants
Interval 74.32 to 92.9
|
|
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Week 96 (n= 49, 51)
|
67.80 Percentage of participants
Interval 55.87 to 79.72
|
81.97 Percentage of participants
Interval 72.32 to 91.62
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 2 (n= 55, 60)
|
27.12 Percentage of participants
Interval 15.77 to 38.46
|
34.43 Percentage of participants
Interval 22.5 to 46.35
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 4 (n= 57, 60)
|
50.85 Percentage of participants
Interval 38.09 to 63.6
|
52.46 Percentage of participants
Interval 39.93 to 64.99
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 8 (n= 57, 59)
|
79.66 Percentage of participants
Interval 69.39 to 89.93
|
77.05 Percentage of participants
Interval 66.5 to 87.6
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 12 (n= 55, 59)
|
89.83 Percentage of participants
Interval 82.12 to 97.54
|
88.52 Percentage of participants
Interval 80.53 to 96.52
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 16 (n= 54, 58)
|
88.14 Percentage of participants
Interval 79.88 to 96.39
|
91.80 Percentage of participants
Interval 84.92 to 98.69
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 20 (n= 56, 57)
|
89.83 Percentage of participants
Interval 82.12 to 97.54
|
93.44 Percentage of participants
Interval 87.23 to 99.65
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 24 (n= 56, 58)
|
91.53 Percentage of participants
Interval 84.42 to 98.63
|
93.44 Percentage of participants
Interval 87.23 to 99.65
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 32 (n= 55, 57)
|
89.83 Percentage of participants
Interval 82.12 to 97.54
|
93.44 Percentage of participants
Interval 87.23 to 99.65
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 40 (n= 54, 55)
|
91.53 Percentage of participants
Interval 84.42 to 98.63
|
90.16 Percentage of participants
Interval 82.69 to 97.64
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 48 (n= 53, 54)
|
89.83 Percentage of participants
Interval 82.12 to 97.54
|
86.89 Percentage of participants
Interval 78.41 to 95.36
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 60 (n= 52, 53)
|
86.44 Percentage of participants
Interval 77.7 to 95.18
|
86.89 Percentage of participants
Interval 78.41 to 95.36
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 72 (n= 52, 53)
|
86.44 Percentage of participants
Interval 77.7 to 95.18
|
85.25 Percentage of participants
Interval 76.35 to 94.15
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 84 (n= 50, 52)
|
81.36 Percentage of participants
Interval 71.42 to 91.29
|
85.25 Percentage of participants
Interval 76.35 to 94.15
|
|
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Week 96 (n= 49, 51)
|
77.97 Percentage of participants
Interval 67.39 to 88.54
|
83.61 Percentage of participants
Interval 74.32 to 92.9
|
SECONDARY outcome
Timeframe: Baseline through Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Time to Loss of Virological Response (TLOVR)
|
436.2 Days
Standard Error 22.5
|
463.8 Days
Standard Error 16.1
|
SECONDARY outcome
Timeframe: Week 16, Week 24, Week 48, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=51 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=52 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Time-Averaged Difference (TAD) in log10 Viral Load
Week 24
|
-2.663 log10 copies/mL
Standard Error 0.048
|
-2.626 log10 copies/mL
Standard Error 0.046
|
|
Time-Averaged Difference (TAD) in log10 Viral Load
Week 48
|
-2.897 log10 copies/mL
Standard Error 0.046
|
-2.868 log10 copies/mL
Standard Error 0.050
|
|
Time-Averaged Difference (TAD) in log10 Viral Load
Week 96
|
-2.998 log10 copies/mL
Standard Error 0.055
|
-3.001 log10 copies/mL
Standard Error 0.053
|
|
Time-Averaged Difference (TAD) in log10 Viral Load
Week 16
|
-2.459 log10 copies/mL
Standard Error 0.046
|
-2.402 log10 copies/mL
Standard Error 0.045
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Change at Week 16 (n= 54, 58)
|
169.60 cells/microliter (cells/mcL)
Standard Deviation 117.20
|
139.80 cells/microliter (cells/mcL)
Standard Deviation 102.62
|
|
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Baseline (n= 59, 61)
|
357.70 cells/microliter (cells/mcL)
Standard Deviation 123.53
|
390.00 cells/microliter (cells/mcL)
Standard Deviation 152.34
|
|
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Change at Week 24 (n= 54, 57)
|
188.90 cells/microliter (cells/mcL)
Standard Deviation 125.14
|
173.30 cells/microliter (cells/mcL)
Standard Deviation 130.55
|
|
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Change at Week 48 (n= 52, 53)
|
215.70 cells/microliter (cells/mcL)
Standard Deviation 166.59
|
226.60 cells/microliter (cells/mcL)
Standard Deviation 138.04
|
|
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Change at Week 96 (n= 50, 51)
|
287.50 cells/microliter (cells/mcL)
Standard Deviation 173.23
|
298.50 cells/microliter (cells/mcL)
Standard Deviation 160.54
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96Population: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Baseline (n= 59, 61)
|
931.10 cells/mcL
Standard Deviation 446.26
|
1125.60 cells/mcL
Standard Deviation 735.08
|
|
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Change at Week 16 (n= 54, 58)
|
63.70 cells/mcL
Standard Deviation 290.49
|
-153.80 cells/mcL
Standard Deviation 473.96
|
|
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Change at Week 24 (n= 54, 57)
|
6.20 cells/mcL
Standard Deviation 334.89
|
-178.00 cells/mcL
Standard Deviation 508.75
|
|
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Change at Week 48 (n= 52, 53)
|
-76.80 cells/mcL
Standard Deviation 354.48
|
-267.60 cells/mcL
Standard Deviation 574.22
|
|
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Change at Week 96 (n= 50, 51)
|
-63.00 cells/mcL
Standard Deviation 355.60
|
-231.40 cells/mcL
Standard Deviation 516.99
|
SECONDARY outcome
Timeframe: Week 96 or Time of treatment failurePopulation: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Number of Participants With Genotypic Resistance
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 96 or Time of treatment failurePopulation: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=59 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Number of Participants With Phenotypic Resistance
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 96 or Time of treatment FailurePopulation: FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} \[X4\]-using HIV-1 RNA represented 0.3 percent of the total viral population.
Outcome measures
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=60 Participants
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir
n=61 Participants
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Baseline
|
60 Participants
|
61 Participants
|
|
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Week 96 or Time of treatment Failure
|
0 Participants
|
0 Participants
|
Adverse Events
Maraviroc+ Atazanavir / Ritonavir
Serious events: 13 serious events
Other events: 55 other events
Deaths: 0 deaths
Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
Serious events: 11 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=60 participants at risk
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
n=61 participants at risk
Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Anogenital warts
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Parotitis
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.3%
2/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Meningitis viral
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Psychotic disorder
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.00%
0/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Maraviroc+ Atazanavir / Ritonavir
n=60 participants at risk
Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
|
Atazanavir / Ritonavir + Emtricitabine/ Tenofovir
n=61 participants at risk
Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
|
|---|---|---|
|
Eye disorders
Ocular icterus
|
21.7%
13/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.5%
7/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
15/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.0%
14/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
3/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
6/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.2%
16/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
8/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
11.5%
7/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
3/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
30.0%
18/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.2%
16/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Jaundice
|
16.7%
10/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Anogenital warts
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
4/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
13.3%
8/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.2%
5/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gonorrhoea
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
2/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
16.7%
10/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
3/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
8/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.1%
8/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood amylase increased
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
2/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
11.7%
7/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.2%
5/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
6/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood uric acid increased
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
3/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
4/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
10.0%
6/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.8%
9/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
11.7%
7/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.1%
8/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
8.3%
5/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
4/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
4/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
9.8%
6/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.3%
2/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
4/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
5/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.6%
4/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.2%
5/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
3/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Syphilis
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
1/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
2/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
3/60 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
2/61 • Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER