Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.
This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Immunodeficiency Virus (HIV)-Infected Participants | HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Adverse Events (Weeks 0-144), Per Event | 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'). | Weeks 0 to 144 |
| Prevalence of Adverse Events (Weeks 0-144), Per Participant | 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'). | Weeks 0 to 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | 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. | Baseline (Week 0) to Week 144 |
| Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | 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. | Baseline (Week 0) to Week 144 |
| Time to Virologic Failure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Community sample: HIV-positive patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bianca Wittig, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HIV-infected Participants | HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of Adverse Events (Weeks 0-144), Per Event | 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'). | Posted | Number | percentage of adverse events | Weeks 0 to 144 | Adverse Events | Adverse Events |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV-infected Participants | HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. |
| Baseline (Week 0) to Week 144 |
| Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis | Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. | Baseline (Week 0) to Week 144 |
| Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL | From Week 0 to Week 144 |
| Number of Participants With Lopinavir (LPV) Resistance 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. | Baseline (Week 0) |
| Number of Participants With LPV Resistance During Follow-Up | 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. | up to Week 144 |
| Number of Participants With Protease Inhibitor (PI) Resistance 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. | Baseline (Week 0) |
| Number of Participants With PI Resistance During Follow-Up | 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. | Up to Week 144 |
| Number of Participants With INI Resistance 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. | Baseline (Week 0) |
| Number of Participants With INI Resistance During Follow-Up | 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. | up to Week 144 |
| Number of Participants With NNRTI Resistance 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. | Baseline (Week 0) |
| Number of Participants With NNRTI Resistance During Follow-Up | 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. | up to Week 144 |
| Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance 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. | Baseline (Week 0) |
| Number of Participants With NRTI Resistance During Follow-Up | 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. | up to Week 144 |
| Number of Participants With HIV-1 Coreceptor Tropism at Baseline | Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline. | Baseline (Week 0) |
| Number of Participants With HIV-1 Coreceptor Tropism During Follow-up | Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up. | up to Week 144 |
Time to virologic failure was defined by the earliest occurrence of:
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). |
| Baseline (Week 0) to Week 144 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
|
|
| Primary | Prevalence of Adverse Events (Weeks 0-144), Per Participant | 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'). | Posted | Number | percentage of participants | Weeks 0 to 144 |
|
|
|
| Secondary | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | 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. | Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. | Posted | Mean | Standard Deviation | cells/μL | Baseline (Week 0) to Week 144 |
|
|
|
| Secondary | Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis | Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. | Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method). | Posted | Number | percentage of participants | Baseline (Week 0) to Week 144 |
|
|
|
| Secondary | Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis | Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care. | 'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point. | Posted | Number | percentage of participants | Baseline (Week 0) to Week 144 |
|
|
|
| Secondary | Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL | Participants with an assessment | Posted | Mean | Standard Error | weeks | From Week 0 to Week 144 |
|
|
|
| Secondary | Number of Participants With Lopinavir (LPV) Resistance 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. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With LPV Resistance During Follow-Up | 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. | Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. | Posted | Count of Participants | Participants | up to Week 144 |
|
|
|
| Secondary | Number of Participants With Protease Inhibitor (PI) Resistance 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. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With PI Resistance During Follow-Up | 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. | Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. | Posted | Count of Participants | Participants | Up to Week 144 |
|
|
|
| Secondary | Number of Participants With INI Resistance 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. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With INI Resistance During Follow-Up | 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. | 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. | Posted | Count of Participants | Participants | up to Week 144 |
|
|
|
| Secondary | Number of Participants With NNRTI Resistance 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. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With NNRTI Resistance During Follow-Up | 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. | Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. | Posted | Count of Participants | Participants | up to Week 144 |
|
|
|
| Secondary | Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance 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. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With NRTI Resistance During Follow-Up | 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. | Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician. | Posted | Count of Participants | Participants | up to Week 144 |
|
|
|
| Secondary | Number of Participants With HIV-1 Coreceptor Tropism at Baseline | Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline. | Participants with an assessment at Baseline | Posted | Count of Participants | Participants | Baseline (Week 0) |
|
|
|
| Secondary | Number of Participants With HIV-1 Coreceptor Tropism During Follow-up | Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up. | 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. | Posted | up to Week 144 |
|
|
| Other Pre-specified | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | 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. | Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point. | Posted | Mean | Standard Deviation | log copies/mL | Baseline (Week 0) to Week 144 |
|
|
|
| Other Pre-specified | Time to Virologic Failure | Time to virologic failure was defined by the earliest occurrence of:
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). | Participants with an assessment | Posted | Mean | Standard Error | weeks | Baseline (Week 0) to Week 144 |
|
|
|
| 30 |
| 501 |
| 0 |
| 0 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| AIDS DEMENTIA COMPLEX | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ACUTE HEPATITIS C | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| CHLAMYDIAL INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| INJECTION SITE ABSCESS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| LYMPHOGRANULOMA VENEREUM | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PNEUMOCOCCAL SEPSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| YERSINIA INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| ACTINOMYCES TEST POSITIVE | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| INFLAMMATORY MARKER INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| STREPTOCOCCUS TEST POSITIVE | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| TROPONIN INCREASED | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| METABOLIC DISORDER | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| FASCIITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| BUSCHKE-LOWENSTEIN'S TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| KAPOSI'S SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| NEUROENDOCRINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| PANCREATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CAROTID ARTERY ANEURYSM | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CAROTID ARTERY THROMBOSIS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DEMENTIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| VERTEBRAL ARTERY STENOSIS | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| WHITE MATTER LESION | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DELUSION | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| SPUTUM DISCOLOURED | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| LIPODYSTROPHY ACQUIRED | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ARTERIAL STENOSIS | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| 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 |
|
| Not Specified |
|
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at Week 60 |
|
|
| Change at Week 72 |
|
|
| Change at Week 84 |
|
|
| Change at Week 96 |
|
|
| Change at Week 108 |
|
|
| Change at Week 120 |
|
|
| Change at Week 132 |
|
|
| Change at Week 144 |
|
|
| Title | Measurements |
|---|
|
| Week 36 |
|
| Week 48 |
|
| Week 60 |
|
| Week 72 |
|
| Week 84 |
|
| Week 96 |
|
| Week 108 |
|
| Week 120 |
|
| Week 132 |
|
| Week 144 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Week 60 |
|
|
| Week 72 |
|
|
| Week 84 |
|
|
| Week 96 |
|
|
| Week 108 |
|
|
| Week 120 |
|
|
| Week 132 |
|
|
| Week 144 |
|
|
| Measurements |
|---|
|
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at Week 60 |
|
|
| Change at Week 72 |
|
|
| Change at Week 84 |
|
|
| Change at Week 96 |
|
|
| Change at Week 108 |
|
|
| Change at Week 120 |
|
|
| Change at Week 132 |
|
|
| Change at Week 144 |
|
|