Trial Outcomes & Findings for Kaletra in Combination With Antiretroviral Agents (NCT NCT01076179)
NCT ID: NCT01076179
Last Updated: 2017-05-19
Results Overview
Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Recruitment status
COMPLETED
Target enrollment
502 participants
Primary outcome timeframe
Weeks 0 to 144
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
HIV-infected Participants
Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
|
|---|---|
|
Overall Study
STARTED
|
502
|
|
Overall Study
COMPLETED
|
501
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HIV-infected Participants
Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Kaletra in Combination With Antiretroviral Agents
Baseline characteristics by cohort
| Measure |
HIV-infected Participants
n=501 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
431 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 0 to 144Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Outcome measures
| Measure |
HIV-infected Participants
n=3450 Adverse Events
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Hypertriglyceridemia
|
13.8 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Hypercholesterolemia
|
19.3 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Low HDL Cholesterol
|
1.0 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
High LDL Cholesterol
|
4.4 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Hyperglycemia
|
1.6 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Hyperbilirubinemia
|
1.8 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Elevated AST
|
3.4 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Elevated ALT
|
4.6 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Elevated γGT
|
6.3 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Elevated Alkaline Phosphatase
|
1.5 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Stomatitis
|
0.6 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Nausea
|
3.1 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Vomiting
|
1.2 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Diarrhea
|
14.9 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Abdominal Pain
|
3.1 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Mood Disorder
|
5.2 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Neurocerebellar Disorder
|
0.8 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Headache
|
1.3 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Fatigue
|
1.7 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Fever
|
1.2 percentage of adverse events
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Event
Not Specified
|
9.1 percentage of adverse events
|
PRIMARY outcome
Timeframe: Weeks 0 to 144Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
Outcome measures
| Measure |
HIV-infected Participants
n=501 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Elevated AST
|
5.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Vomiting
|
4.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Fever
|
4.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hypertriglyceridemia
|
14.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hypercholesterolemia
|
17.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Low HDL Cholesterol
|
3.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
High LDL Cholesterol
|
7.2 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hyperglycemia
|
2.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hyperbilirubinemia
|
2.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Elevated ALT
|
6.4 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Elevated γGT
|
7.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Elevated Alkaline Phosphatase
|
3.2 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Stomatitis
|
2.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Nausea
|
8.6 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Diarrhea
|
27.3 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Abdominal Pain
|
7.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Mood Disorder
|
9.8 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Neurocerebellar Disorder
|
2.2 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Headache
|
4.0 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Fatigue
|
4.6 percentage of participants
|
|
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Not Specified
|
28.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 144Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Outcome measures
| Measure |
HIV-infected Participants
n=500 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 4
|
54.0 cells/μL
Standard Deviation 161.7
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 12
|
64.6 cells/μL
Standard Deviation 148.5
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 24
|
78.8 cells/μL
Standard Deviation 195.3
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 36
|
95.8 cells/μL
Standard Deviation 214.4
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 48
|
107.4 cells/μL
Standard Deviation 213.2
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 60
|
131.0 cells/μL
Standard Deviation 247.7
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 72
|
125.3 cells/μL
Standard Deviation 216.1
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 84
|
142.8 cells/μL
Standard Deviation 223.9
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 96
|
143.3 cells/μL
Standard Deviation 207.0
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 108
|
155.3 cells/μL
Standard Deviation 219.8
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 120
|
170.9 cells/μL
Standard Deviation 233.0
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 132
|
180.3 cells/μL
Standard Deviation 243.3
|
|
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Change at Week 144
|
190.0 cells/μL
Standard Deviation 252.9
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 144Population: Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).
Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Outcome measures
| Measure |
HIV-infected Participants
n=501 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 4
|
23.8 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 12
|
36.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 24
|
45.7 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 36
|
53.1 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 48
|
58.1 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 60
|
62.7 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 72
|
65.1 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 84
|
67.7 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 96
|
70.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 108
|
72.3 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 120
|
72.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 132
|
73.1 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Week 144
|
73.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 144Population: 'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.
Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Outcome measures
| Measure |
HIV-infected Participants
n=501 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 4
|
32.2 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 12
|
32.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 24
|
37.9 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 36
|
43.8 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 48
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 60
|
50.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 72
|
50.3 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 84
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 96
|
55.8 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 108
|
60.1 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 120
|
58.0 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 132
|
58.0 percentage of participants
|
|
Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Week 144
|
61.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Week 0 to Week 144Population: Participants with an assessment
Outcome measures
| Measure |
HIV-infected Participants
n=498 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
|
56.1 weeks
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=159 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With Lopinavir (LPV) Resistance at Baseline
Susceptible
|
155 Participants
|
|
Number of Participants With Lopinavir (LPV) Resistance at Baseline
Resistance/Partial Resistance
|
4 Participants
|
SECONDARY outcome
Timeframe: up to Week 144Population: Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=6 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With LPV Resistance During Follow-Up
Susceptible
|
5 Participants
|
|
Number of Participants With LPV Resistance During Follow-Up
Resistance/Partial Resistance
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=159 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
Susceptible
|
142 Participants
|
|
Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
Resistance/Partial Resistance
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to Week 144Population: Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=6 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With PI Resistance During Follow-Up
Susceptible
|
5 Participants
|
|
Number of Participants With PI Resistance During Follow-Up
Resistance/Partial Resistance
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=9 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With INI Resistance at Baseline
Susceptible
|
8 Participants
|
|
Number of Participants With INI Resistance at Baseline
Resistance/Partial Resistance
|
1 Participants
|
SECONDARY outcome
Timeframe: up to Week 144Population: Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=2 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With INI Resistance During Follow-Up
Susceptible
|
0 Participants
|
|
Number of Participants With INI Resistance During Follow-Up
Resistance/Partial Resistance
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=159 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With NNRTI Resistance at Baseline
Resistance/Partial Resistance
|
46 Participants
|
|
Number of Participants With NNRTI Resistance at Baseline
Susceptible
|
113 Participants
|
SECONDARY outcome
Timeframe: up to Week 144Population: Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=6 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With NNRTI Resistance During Follow-Up
Susceptible
|
5 Participants
|
|
Number of Participants With NNRTI Resistance During Follow-Up
Resistance/Partial Resistance
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=159 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
Susceptible
|
96 Participants
|
|
Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
Resistance/Partial Resistance
|
63 Participants
|
SECONDARY outcome
Timeframe: up to Week 144Population: Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
Outcome measures
| Measure |
HIV-infected Participants
n=6 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With NRTI Resistance During Follow-Up
Susceptible
|
4 Participants
|
|
Number of Participants With NRTI Resistance During Follow-Up
Resistance/Partial Resistance
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0)Population: Participants with an assessment at Baseline
Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.
Outcome measures
| Measure |
HIV-infected Participants
n=108 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Number of Participants With HIV-1 Coreceptor Tropism at Baseline
CCR5 tropic
|
74 Participants
|
|
Number of Participants With HIV-1 Coreceptor Tropism at Baseline
CRCX4 tropic
|
21 Participants
|
|
Number of Participants With HIV-1 Coreceptor Tropism at Baseline
Dual/mixed tropic
|
13 Participants
|
SECONDARY outcome
Timeframe: up to Week 144Population: Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected.
Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) to Week 144Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
Outcome measures
| Measure |
HIV-infected Participants
n=500 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 4
|
-1.37 log copies/mL
Standard Deviation 1.40
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 12
|
-1.53 log copies/mL
Standard Deviation 1.63
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 24
|
-1.45 log copies/mL
Standard Deviation 1.70
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 36
|
-1.49 log copies/mL
Standard Deviation 1.69
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 48
|
-1.46 log copies/mL
Standard Deviation 1.68
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 60
|
-1.27 log copies/mL
Standard Deviation 1.62
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 72
|
-1.32 log copies/mL
Standard Deviation 1.65
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 84
|
-1.34 log copies/mL
Standard Deviation 1.64
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 96
|
-1.36 log copies/mL
Standard Deviation 1.59
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 108
|
-1.32 log copies/mL
Standard Deviation 1.67
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 120
|
-1.29 log copies/mL
Standard Deviation 1.73
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 132
|
-1.33 log copies/mL
Standard Deviation 1.65
|
|
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Change at Week 144
|
-1.38 log copies/mL
Standard Deviation 1.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) to Week 144Population: Participants with an assessment
Time to virologic failure was defined by the earliest occurrence of: 1. HIV-1 RNA \> 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA \< 50 copies/mL, 2. HIV-1 RNA \> 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA \< 50 copies/mL but subsequently did not have HIV-1 RNA \> 400 copies/mL on 2 consecutive occasions, or 3. Day 1 if the participant never achieved HIV-1 RNA \< 50 copies/mL during study participation. A participant who prematurely discontinued study drug with HIV-1 RNA \< 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c).
Outcome measures
| Measure |
HIV-infected Participants
n=499 Participants
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|---|---|
|
Time to Virologic Failure
|
194.4 weeks
Standard Error 6.2
|
Adverse Events
HIV-infected Participants
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV-infected Participants
n=501 participants at risk
HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
|
|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.40%
2/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.80%
4/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Gastrointestinal disorders
NAUSEA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Gastrointestinal disorders
VOMITING
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
General disorders
ASTHENIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
General disorders
FATIGUE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.40%
2/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
General disorders
PYREXIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
AIDS DEMENTIA COMPLEX
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
ACUTE HEPATITIS C
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
ANAL ABSCESS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
CHLAMYDIAL INFECTION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
INFECTION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
INJECTION SITE ABSCESS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
LYMPHOGRANULOMA VENEREUM
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
PNEUMONIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
SEPSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
TUBERCULOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Infections and infestations
YERSINIA INFECTION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Injury, poisoning and procedural complications
FALL
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
ACTINOMYCES TEST POSITIVE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.40%
2/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
INFLAMMATORY MARKER INCREASED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
STREPTOCOCCUS TEST POSITIVE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Investigations
TROPONIN INCREASED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.40%
2/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Metabolism and nutrition disorders
METABOLIC DISORDER
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Musculoskeletal and connective tissue disorders
FASCIITIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BUSCHKE-LOWENSTEIN'S TUMOUR
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
KAPOSI'S SARCOMA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEUROENDOCRINE CARCINOMA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEOPLASM
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
CAROTID ARTERY ANEURYSM
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
CAROTID ARTERY THROMBOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
DEMENTIA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
SEIZURE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
SYNCOPE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
VERTEBRAL ARTERY STENOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Nervous system disorders
WHITE MATTER LESION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Psychiatric disorders
DELUSION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Psychiatric disorders
DEPRESSION
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.40%
2/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM DISCOLOURED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Skin and subcutaneous tissue disorders
LIPODYSTROPHY ACQUIRED
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Vascular disorders
ARTERIAL STENOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.20%
1/501 • Up to Week 144
Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER