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Kaletra in Combination With Antiretroviral Agents (PROTEKT)

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ClinicalTrials.gov Identifier: NCT01076179
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Enrollment 502
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description 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
Period Title: Overall Study
Started 502
Completed 501
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Baseline Participants 501
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 501 participants
45.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants
Female
70
  14.0%
Male
431
  86.0%
1.Primary Outcome
Title Prevalence of Adverse Events (Weeks 0-144), Per Event
Hide Description 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').
Time Frame Weeks 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 501
Overall Number of Units Analyzed
Type of Units Analyzed: Adverse Events
3450
Measure Type: Number
Unit of Measure: percentage of adverse events
Hypertriglyceridemia 13.8
Hypercholesterolemia 19.3
Low HDL Cholesterol 1.0
High LDL Cholesterol 4.4
Hyperglycemia 1.6
Hyperbilirubinemia 1.8
Elevated AST 3.4
Elevated ALT 4.6
Elevated γGT 6.3
Elevated Alkaline Phosphatase 1.5
Stomatitis 0.6
Nausea 3.1
Vomiting 1.2
Diarrhea 14.9
Abdominal Pain 3.1
Mood Disorder 5.2
Neurocerebellar Disorder 0.8
Headache 1.3
Fatigue 1.7
Fever 1.2
Not Specified 9.1
2.Primary Outcome
Title Prevalence of Adverse Events (Weeks 0-144), Per Participant
Hide Description Percentage 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').
Time Frame Weeks 0 to 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 501
Measure Type: Number
Unit of Measure: percentage of participants
Hypertriglyceridemia 14.8
Hypercholesterolemia 17.8
Low HDL Cholesterol 3.0
High LDL Cholesterol 7.2
Hyperglycemia 2.8
Hyperbilirubinemia 2.8
Elevated AST 5.0
Elevated ALT 6.4
Elevated γGT 7.8
Elevated Alkaline Phosphatase 3.2
Stomatitis 2.0
Nausea 8.6
Vomiting 4.0
Diarrhea 27.3
Abdominal Pain 7.8
Mood Disorder 9.8
Neurocerebellar Disorder 2.2
Headache 4.0
Fatigue 4.6
Fever 4.0
Not Specified 28.5
3.Secondary Outcome
Title Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
Hide Description 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.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 500
Mean (Standard Deviation)
Unit of Measure: cells/μL
Change at Week 4 Number Analyzed 369 participants
54.0  (161.7)
Change at Week 12 Number Analyzed 400 participants
64.6  (148.5)
Change at Week 24 Number Analyzed 414 participants
78.8  (195.3)
Change at Week 36 Number Analyzed 363 participants
95.8  (214.4)
Change at Week 48 Number Analyzed 344 participants
107.4  (213.2)
Change at Week 60 Number Analyzed 315 participants
131.0  (247.7)
Change at Week 72 Number Analyzed 300 participants
125.3  (216.1)
Change at Week 84 Number Analyzed 266 participants
142.8  (223.9)
Change at Week 96 Number Analyzed 265 participants
143.3  (207.0)
Change at Week 108 Number Analyzed 233 participants
155.3  (219.8)
Change at Week 120 Number Analyzed 219 participants
170.9  (233.0)
Change at Week 132 Number Analyzed 212 participants
180.3  (243.3)
Change at Week 144 Number Analyzed 212 participants
190.0  (252.9)
4.Secondary Outcome
Title Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
Hide Description Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 501
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 23.8
Week 12 36.5
Week 24 45.7
Week 36 53.1
Week 48 58.1
Week 60 62.7
Week 72 65.1
Week 84 67.7
Week 96 70.5
Week 108 72.3
Week 120 72.5
Week 132 73.1
Week 144 73.7
5.Secondary Outcome
Title Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
Hide Description Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 501
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 Number Analyzed 369 participants
32.2
Week 12 Number Analyzed 400 participants
32.5
Week 24 Number Analyzed 414 participants
37.9
Week 36 Number Analyzed 363 participants
43.8
Week 48 Number Analyzed 344 participants
48.0
Week 60 Number Analyzed 315 participants
50.5
Week 72 Number Analyzed 300 participants
50.3
Week 84 Number Analyzed 266 participants
54.5
Week 96 Number Analyzed 265 participants
55.8
Week 108 Number Analyzed 233 participants
60.1
Week 120 Number Analyzed 219 participants
58.0
Week 132 Number Analyzed 212 participants
58.0
Week 144 Number Analyzed 212 participants
61.3
6.Secondary Outcome
Title Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
Hide Description [Not Specified]
Time Frame From Week 0 to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 498
Mean (Standard Error)
Unit of Measure: weeks
56.1  (2.8)
7.Secondary Outcome
Title Number of Participants With Lopinavir (LPV) Resistance at Baseline
Hide Description

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.

Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 159
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
155
  97.5%
Resistance/Partial Resistance
4
   2.5%
8.Secondary Outcome
Title Number of Participants With LPV Resistance During Follow-Up
Hide Description 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.
Time Frame up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
5
  83.3%
Resistance/Partial Resistance
1
  16.7%
9.Secondary Outcome
Title Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
Hide Description

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.

Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 159
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
142
  89.3%
Resistance/Partial Resistance
17
  10.7%
10.Secondary Outcome
Title Number of Participants With PI Resistance During Follow-Up
Hide Description 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.
Time Frame Up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
5
  83.3%
Resistance/Partial Resistance
1
  16.7%
11.Secondary Outcome
Title Number of Participants With INI Resistance at Baseline
Hide Description 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.
Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
8
  88.9%
Resistance/Partial Resistance
1
  11.1%
12.Secondary Outcome
Title Number of Participants With INI Resistance During Follow-Up
Hide Description 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.
Time Frame up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
0
   0.0%
Resistance/Partial Resistance
2
 100.0%
13.Secondary Outcome
Title Number of Participants With NNRTI Resistance at Baseline
Hide Description 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.
Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 159
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
113
  71.1%
Resistance/Partial Resistance
46
  28.9%
14.Secondary Outcome
Title Number of Participants With NNRTI Resistance During Follow-Up
Hide Description 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.
Time Frame up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
5
  83.3%
Resistance/Partial Resistance
1
  16.7%
15.Secondary Outcome
Title Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
Hide Description 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.
Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 159
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
96
  60.4%
Resistance/Partial Resistance
63
  39.6%
16.Secondary Outcome
Title Number of Participants With NRTI Resistance During Follow-Up
Hide Description 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.
Time Frame up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Susceptible
4
  66.7%
Resistance/Partial Resistance
2
  33.3%
17.Secondary Outcome
Title Number of Participants With HIV-1 Coreceptor Tropism at Baseline
Hide Description Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.
Time Frame Baseline (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 108
Measure Type: Count of Participants
Unit of Measure: Participants
CCR5 tropic
74
  68.5%
CRCX4 tropic
21
  19.4%
Dual/mixed tropic
13
  12.0%
18.Secondary Outcome
Title Number of Participants With HIV-1 Coreceptor Tropism During Follow-up
Hide Description Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.
Time Frame up to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
19.Other Pre-specified Outcome
Title Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
Hide Description 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.
Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
Overall Number of Participants Analyzed 500
Mean (Standard Deviation)
Unit of Measure: log copies/mL
Change at Week 4 Number Analyzed 389 participants
-1.37  (1.40)
Change at Week 12 Number Analyzed 408 participants
-1.53  (1.63)
Change at Week 24 Number Analyzed 413 participants
-1.45  (1.70)
Change at Week 36 Number Analyzed 367 participants
-1.49  (1.69)
Change at Week 48 Number Analyzed 347 participants
-1.46  (1.68)
Change at Week 60 Number Analyzed 320 participants
-1.27  (1.62)
Change at Week 72 Number Analyzed 304 participants
-1.32  (1.65)
Change at Week 84 Number Analyzed 269 participants
-1.34  (1.64)
Change at Week 96 Number Analyzed 265 participants
-1.36  (1.59)
Change at Week 108 Number Analyzed 233 participants
-1.32  (1.67)
Change at Week 120 Number Analyzed 225 participants
-1.29  (1.73)
Change at Week 132 Number Analyzed 213 participants
-1.33  (1.65)
Change at Week 144 Number Analyzed 216 participants
-1.38  (1.68)
20.Other Pre-specified Outcome
Title Time to Virologic Failure
Hide Description

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).

Time Frame Baseline (Week 0) to Week 144
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description:
HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
Overall Number of Participants Analyzed 499
Mean (Standard Error)
Unit of Measure: weeks
194.4  (6.2)
Time Frame Up to Week 144
Adverse Event Reporting Description 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.
 
Arm/Group Title HIV-infected Participants
Hide Arm/Group Description HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
All-Cause Mortality
HIV-infected Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIV-infected Participants
Affected / at Risk (%)
Total   30/501 (5.99%) 
Blood and lymphatic system disorders   
LYMPHADENOPATHY * 1  2/501 (0.40%) 
NEUTROPENIA * 1  1/501 (0.20%) 
Cardiac disorders   
CARDIAC FAILURE * 1  1/501 (0.20%) 
Gastrointestinal disorders   
ABDOMINAL PAIN * 1  1/501 (0.20%) 
DIARRHOEA * 1  4/501 (0.80%) 
NAUSEA * 1  1/501 (0.20%) 
STOMATITIS * 1  1/501 (0.20%) 
VOMITING * 1  1/501 (0.20%) 
General disorders   
ASTHENIA * 1  1/501 (0.20%) 
FATIGUE * 1  1/501 (0.20%) 
MULTI-ORGAN FAILURE * 1  2/501 (0.40%) 
OEDEMA PERIPHERAL * 1  1/501 (0.20%) 
PYREXIA * 1  1/501 (0.20%) 
Hepatobiliary disorders   
HYPERBILIRUBINAEMIA * 1  1/501 (0.20%) 
Infections and infestations   
AIDS DEMENTIA COMPLEX * 1  1/501 (0.20%) 
ACUTE HEPATITIS C * 1  1/501 (0.20%) 
ANAL ABSCESS * 1  1/501 (0.20%) 
CHLAMYDIAL INFECTION * 1  1/501 (0.20%) 
CYTOMEGALOVIRUS INFECTION * 1  1/501 (0.20%) 
INFECTION * 1  1/501 (0.20%) 
INJECTION SITE ABSCESS * 1  1/501 (0.20%) 
LYMPHOGRANULOMA VENEREUM * 1  1/501 (0.20%) 
PNEUMOCOCCAL SEPSIS * 1  1/501 (0.20%) 
PNEUMONIA * 1  1/501 (0.20%) 
PNEUMONIA FUNGAL * 1  1/501 (0.20%) 
SEPSIS * 1  1/501 (0.20%) 
SEPTIC SHOCK * 1  1/501 (0.20%) 
SUBCUTANEOUS ABSCESS * 1  1/501 (0.20%) 
TUBERCULOSIS * 1  1/501 (0.20%) 
YERSINIA INFECTION * 1  1/501 (0.20%) 
Injury, poisoning and procedural complications   
FALL * 1  1/501 (0.20%) 
RADIUS FRACTURE * 1  1/501 (0.20%) 
Investigations   
ACTINOMYCES TEST POSITIVE * 1  1/501 (0.20%) 
ALANINE AMINOTRANSFERASE INCREASED * 1  1/501 (0.20%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/501 (0.20%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1  2/501 (0.40%) 
INFLAMMATORY MARKER INCREASED * 1  1/501 (0.20%) 
STREPTOCOCCUS TEST POSITIVE * 1  1/501 (0.20%) 
TROPONIN INCREASED * 1  1/501 (0.20%) 
Metabolism and nutrition disorders   
DEHYDRATION * 1  1/501 (0.20%) 
DIABETES MELLITUS * 1  1/501 (0.20%) 
HYPERGLYCAEMIA * 1  1/501 (0.20%) 
HYPONATRAEMIA * 1  2/501 (0.40%) 
METABOLIC DISORDER * 1  1/501 (0.20%) 
Musculoskeletal and connective tissue disorders   
FASCIITIS * 1  1/501 (0.20%) 
FISTULA * 1  1/501 (0.20%) 
INTERVERTEBRAL DISC PROTRUSION * 1  1/501 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA * 1  1/501 (0.20%) 
BUSCHKE-LOWENSTEIN'S TUMOUR * 1  1/501 (0.20%) 
KAPOSI'S SARCOMA * 1  1/501 (0.20%) 
NEUROENDOCRINE CARCINOMA * 1  1/501 (0.20%) 
PANCREATIC NEOPLASM * 1  1/501 (0.20%) 
Nervous system disorders   
ALTERED STATE OF CONSCIOUSNESS * 1  1/501 (0.20%) 
CAROTID ARTERY ANEURYSM * 1  1/501 (0.20%) 
CAROTID ARTERY STENOSIS * 1  1/501 (0.20%) 
CAROTID ARTERY THROMBOSIS * 1  1/501 (0.20%) 
CEREBROVASCULAR ACCIDENT * 1  1/501 (0.20%) 
DEMENTIA * 1  1/501 (0.20%) 
NERVOUS SYSTEM DISORDER * 1  1/501 (0.20%) 
SEIZURE * 1  1/501 (0.20%) 
SYNCOPE * 1  1/501 (0.20%) 
TRANSIENT ISCHAEMIC ATTACK * 1  1/501 (0.20%) 
VERTEBRAL ARTERY STENOSIS * 1  1/501 (0.20%) 
WHITE MATTER LESION * 1  1/501 (0.20%) 
Psychiatric disorders   
ACUTE PSYCHOSIS * 1  1/501 (0.20%) 
DELUSION * 1  1/501 (0.20%) 
DEPRESSION * 1  1/501 (0.20%) 
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE * 1  1/501 (0.20%) 
COUGH * 1  2/501 (0.40%) 
DYSPNOEA * 1  1/501 (0.20%) 
DYSPNOEA EXERTIONAL * 1  1/501 (0.20%) 
INTERSTITIAL LUNG DISEASE * 1  1/501 (0.20%) 
PULMONARY OEDEMA * 1  1/501 (0.20%) 
SPUTUM DISCOLOURED * 1  1/501 (0.20%) 
Skin and subcutaneous tissue disorders   
DECUBITUS ULCER * 1  1/501 (0.20%) 
LIPODYSTROPHY ACQUIRED * 1  1/501 (0.20%) 
Vascular disorders   
ARTERIAL STENOSIS * 1  1/501 (0.20%) 
ARTERIOSCLEROSIS * 1  1/501 (0.20%) 
CIRCULATORY COLLAPSE * 1  1/501 (0.20%) 
DEEP VEIN THROMBOSIS * 1  1/501 (0.20%) 
HYPERTENSIVE CRISIS * 1  1/501 (0.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV-infected Participants
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01076179     History of Changes
Other Study ID Numbers: P11-021
First Submitted: February 24, 2010
First Posted: February 26, 2010
Results First Submitted: January 18, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017