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| ID | Type | Description | Link |
|---|---|---|---|
| WEUKSTV2430 | Other Identifier | GSK | |
| EPI40537 | Other Identifier | GSK |
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APV10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (FPV/RTV) at reduced doses over 14 days in HIV-infected subjects with mild to moderate hepatic impairment (HI). Based on these data, two new regimens have recently been approved by the EMEA and FDA in these patient groups; FPV 700mg BID/RTV 100mg QD for those with mild HI (Child-Pugh score 4-6) and FPV 450mg BID/RTV 100mg QD for those with moderate HI (Child Pugh score 7-9). The Committee for Medicinal Products for Human Use (CHMP) has requested longer-term safety data among this hepatically impaired HIV-infected population who have received the recently updated FPV/RTV dosing regimens.
An observational cohort study will be conducted using routinely collected data in three European HIV patient cohorts with a high proportion of hepatitis co-infected individuals. Patients who received FPV/RTV will be followed to address the following objectives.
Primary: To assess the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment.
Secondary: A). To compare the safety and tolerability of FPV/RTV-based ART in subjects with mild to moderate hepatic impairment when compared to FPV/RTV-based ART in hepatitis B (HBV) or hepatitis C (HCV) co-infected subjects with normal hepatic function. B). To compare the safety and tolerability of FPV/RTV-based ART to lopinavir/ritonavir LPV/RTV-based ART in subjects with mild to moderate hepatic impairment.
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV pts w/ HBV or HCV, w/ or w/o mild to moderate HI | Patients with HIV coinfected with HBV or HCV with or without mild to moderate HI who are enrolled in one of the participating HIV patient cohorts. These patients will be exposed to FPV/RTV or LPV/RTV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention A Standard dose | Drug | HIV subjects with HBV or HCV co-infection but normal hepatic function, defined by receipt of FPV 700mg BID/RTV 100mg BID and a baseline AST-platelet ratio index (APRI) score of <2.0. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | Incidence was assessed over time during Year 1 |
| Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | An elevation in ALT is defined as a single value >200 IU/I. | Incidence was assessed over time during Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables |
| Measure | Description | Time Frame |
|---|---|---|
| Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV. | Baseline |
| Cluster of Differentiation (CD4) Count at Baseline |
Inclusion Criteria:
Exclusion Criteria:
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The source population is from three HIV patient cohorts; ICONA, HEPAVIH and MASTER cohort in Europe. Data from these cohorts are comprised of the clinical records (or a defined subset thereof) of HIV infected patients. The ICONA Foundation study collects data on HIV infected individuals from 67 infectious disease centres across Italy and has been established since 1997. The ICONA cohort only includes patients who are treatment naïve at initial presentation. HEPAVIH is a cohort of HIV-hepatitis co-infected patients, identified from three other ongoing French HIV cohorts: RIBAVIC, SEROCO and AQUITAINE and an additional 12 clinical departments. The MASTER cohort collects data on HIV infected individuals from centres across Italy and includes treatment-experienced and naive patients.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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As this was an observational, retrospective study, no participants were recruited for participation in this study. For more information about this study, see the protocol in ClinicalTrials.gov and/or search for this study (111949) on http://www.gsk-clinicalstudyregister.com/.
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| ID | Title | Description |
|---|---|---|
| FG000 | FPV 700 mg BID/RTV 100 mg BID | Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID |
| FG001 | FPV 700 mg BID/RTV 100 mg QD | FPV 700 mg BID/RTV 100 mg once a day (QD) |
| FG002 | FPV, Other | All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD) |
| FG003 | LPV, Standard Dose | Lopinavir (LPV), Standard Dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FPV 700 mg BID/RTV 100 mg BID | Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID |
| BG001 | FPV 700 mg BID/RTV 100 mg QD | FPV 700 mg BID/RTV 100 mg once a day (QD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT |
|
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This is a retrospective study of pre-existing data; thus, no assessments for Serious or Non-serious Adverse Events were performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FPV 700 mg BID/RTV 100 mg BID | Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Intervention B Reduced Dose | Drug | HIV subjects with mild hepatic impairment, defined by receipt of the recommended reduced FPV/RTV dose (700mg BID/100mg QD). |
|
| Intervention C | Drug | HIV subjects with moderate hepatic impairment, defined by receipt of FPV 450mg BID/RTV 100mg QD. |
|
| Intervention D | Drug | HIV subjects receiving the standard dose of FPV/RTV despite evidence of abnormal hepatic function according to APRI score: HIV subjects with HBV or HCV co-infection, receipt of FPV 700mg BID/RTV 100mg BID and a baseline APRI score of ≥2.0. |
|
| Intervention E | Drug | HIV subjects coinfected with HBV or HCV who have initiated standard doses of LPV 400mg/RTV 100mg and enrolled in the same cohorts as the FPV/RTV exposed subjects. |
|
A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. |
| Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments) | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. | Incidence was assessed over time during Year 1 |
| Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only | Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only | Incidence was assessed over time during Year 1 |
| Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available). | Incidence was assessed over time during Year 1 |
| Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r | Assessed over time during Year 1 |
| Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen | Assessed over time during Year 1 |
| Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only | Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available) | The incidence of these events was assessed over time during Year 1 |
| Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures | Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population. | Incidence of these events was assessed over time during Year 1 |
Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system. |
| Baseline |
| Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis. | Baseline |
| Median FIB (a Model of End-stage Liver Disease) Score at Baseline | The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis). | Baseline |
| Median Model of End-stage Liver Disease (MELD) Score at Baseline | MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30-39, 83% mortality; 20-29, 76% mortality; 10-19, 27% mortality. | Baseline |
| Median ALT and AST Scores at Baseline | Participants characteristics at baseline according to treatment group. | Baseline |
| Median Blood Platelet Count at Baseline | Participant characteristics at baseline according to treatment group. | Baseline |
| Median Bilirubin Level at Baseline | Participant characteristics at baseline according to treatment group. | Baseline |
| BG002 | FPV, Other | All other dosages of Fosamprenavir |
| BG003 | LPV, Standard Dose | Lopinavir (LPV), Standard Dose |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Cohort Distribution | Source population from three human immunodeficiency virus (HIV)-infected patient cohorts: ICONA (Italian Cohort of Antiretroviral Naïve Patients), treatment naïve participants at initial presentation in Italy; HEPAVIH, HIV-hepatitis coinfected in France; MASTER (Management Standardizzato di Terapia Antiretrovirale), HIV-infected participants who are either treatment experienced or naïve patients in Italy | Number | participants |
|
| Number of participants positive for Hepatitis B and/or C at baseline | Participant characteristics at baseline according to treatment group. Participants were tested for Hepatitis C antibody (HCV-Ab) and Hepatitis B surface antigen (HBs-Ag). | Number | participants |
|
| Number of participants who were ART naïve at baseline | Participant characteristics at baseline according to treatment group. The number of participants who had not received antiretroviral therapy (ART) was recorded. | Number | participants |
|
| Number of participants with acquired immunodeficiency syndrome (AIDS) at baseline | Participant characteristics at baseline according to treatment group. The number of participants with AIDS was recorded. | Number | participants |
|
| Number of participants with the indicated alanine aminotransferase (ALT) levels at baseline | Participant characteristics at baseline according to treatment group. The number of participants with the indicated ALT levels was recorded. IU/L = International Units per Liter. | Number | participants |
|
|
|
|
| Primary | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT |
|
|
|
|
| Primary | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables | An elevation in ALT is defined as a single value >200 IU/I. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Primary | Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | An elevation in ALT is defined as a single value >200 IU/I. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Other Pre-specified | Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline | Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | years | Baseline |
|
|
|
| Secondary | Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Other Pre-specified | Cluster of Differentiation (CD4) Count at Baseline | Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | cells/microliter (μl) | Baseline |
|
|
|
| Other Pre-specified | Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline | The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | APRI Score | Baseline |
|
|
|
| Other Pre-specified | Median FIB (a Model of End-stage Liver Disease) Score at Baseline | The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis). | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | FIB Score | Baseline |
|
|
|
| Other Pre-specified | Median Model of End-stage Liver Disease (MELD) Score at Baseline | MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30-39, 83% mortality; 20-29, 76% mortality; 10-19, 27% mortality. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the "FPV 700 mg BID/RTV 100 mg QD" group due to missing data. | Posted | Median | Full Range | MELD score | Baseline |
|
|
|
| Other Pre-specified | Median ALT and AST Scores at Baseline | Participants characteristics at baseline according to treatment group. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | IU/L (International Units per Liter) | Baseline |
|
|
|
| Secondary | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only | A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments) | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts | A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only | Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
|
| Secondary | Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events | Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available). | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | events | Incidence was assessed over time during Year 1 |
|
|
|
| Secondary | Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r | Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | participants | Assessed over time during Year 1 |
|
|
|
| Secondary | Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen | Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | participants | Assessed over time during Year 1 |
|
|
|
| Secondary | Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only | Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available) | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | participants | The incidence of these events was assessed over time during Year 1 |
|
|
|
| Secondary | Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures | Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Number | incidence rate | Incidence of these events was assessed over time during Year 1 |
|
|
|
| Other Pre-specified | Median Blood Platelet Count at Baseline | Participant characteristics at baseline according to treatment group. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | 10^9/liter | Baseline |
|
|
|
| Other Pre-specified | Median Bilirubin Level at Baseline | Participant characteristics at baseline according to treatment group. | HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe | Posted | Median | Full Range | milligrams (mg)/deciliter (dl) | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | FPV 700 mg BID/RTV 100 mg QD | FPV 700 mg BID/RTV 100 mg once a day (QD) | 0 | 0 | 0 | 0 |
| EG002 | FPV, Other | All other dosages of Fosamprenavir | 0 | 0 | 0 | 0 |
| EG003 | LPV, Standard Dose | Lopinavir (LPV), Standard Dose | 0 | 0 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
|
| Regression, Cox |
| 0.68 |
Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin. |
| Hazard Ratio (HR) |
| 1.62 |
| 95 |
| 0.16 |
| 16.27 |
Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group. |
| No |
| Superiority or Other |
|
| Regression, Cox |
| 0.85 |
Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin. |
| Hazard Ratio (HR) |
| 1.26 |
| 95 |
| 0.12 |
| 13.33 |
Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group. |
| No |
| Superiority or Other |
|
| Regression, Cox |
| 0.96 |
Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin. |
| Hazard Ratio (HR) |
| 1.06 |
| 95 |
| 0.11 |
| 9.83 |
Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group. |
| No |
| Superiority or Other |
|
| Regression, Cox |
| 0.22 |
Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05. |
| Hazard Ratio (HR) |
| 0.28 |
| 95 |
| 0.04 |
| 2.14 |
Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group. |
| No |
| Superiority or Other |
| Regression, Cox | 0.47 | Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05. | Hazard Ratio (HR) | 1.86 | 95 | 0.35 | 9.91 | Confidence Interval and Hazard Ratio for "FPV, Other." "LPV" is the reference group. | No | Superiority or Other |
|
| Regression, Cox |
| 0.23 |
Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin. |
| Hazard Ratio (HR) |
| 0.26 |
| 95 |
| 0.03 |
| 2.18 |
Confidence Interval and Hazard Ratio for "FPV 700 mg BID/RTV 100 mg QD." "LPV" is the reference group. |
| No |
| Superiority or Other |
| Regression, Cox | 0.56 | Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin. | Hazard Ratio (HR) | 1.67 | 95 | 0.29 | 9.47 | Confidence Interval and Hazard Ratio for "FPV, Other." "LPV" is the reference group. | No | Superiority or Other |
| Tiime on ART |
|
| Regression, Cox |
| 0.21 |
Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin. |
| Hazard Ratio (HR) |
| 0.27 |
| 95 |
| 0.03 |
| 2.08 |
Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group. |
| No |
| Superiority or Other |
| Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin. | Regression, Cox | 0.15 | Hazard Ratio (HR) | 2.26 | 95 | 0.74 | 6.97 | Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group. | No | Superiority or Other |
| AST |
|
|
| Regression, Cox |
| 0.05 |
Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin. |
| Hazard Ratio (HR) |
| 4.17 |
| 95 |
| 1.54 |
| 11.27 |
Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group. |
| No |
| Superiority or Other |
| Regression, Cox | 0.06 | Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin. | Hazard Ratio (HR) | 3.67 | 95 | 0.97 | 13.90 | Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group. | No | Superiority or Other |
| Regression, Cox |
| 0.0004 |
Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin. |
| Hazard Ratio (HR) |
| 4.42 |
| 95 |
| 1.61 |
| 12.08 |
Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group. |
| No |
| Superiority or Other |
| Regression, Cox | 0.11 | Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin. | Hazard Ratio (HR) | 3.07 | 95 | 0.78 | 12.03 | Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group. | No | Superiority or Other |
| Regression, Cox |
| 0.05 |
Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin. |
| Hazard Ratio (HR) |
| 3.61 |
| 95 |
| 1.48 |
| 8.81 |
Confidence Interval and Hazard Ratio for " FPV 700 mg BID/RTV 100 mg QD". "LPV" is the reference group. |
| No |
| Superiority or Other |
| Regression, Cox | 0.10 | Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin. | Hazard Ratio (HR) | 2.31 | 95 | 0.85 | 6.32 | Confidence Interval and Hazard Ratio for " FPV, other". "LPV" is the reference group. | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Nervous system |
|
| Kidneys |
|
| Other side effects (not specified as above) |
|
| Lopinavir/r |
|
| Fos-amprenavir/r |
|
| Lamivudine |
|
| Abacavir |
|
| Combivir |
|
| Truvada |
|
| Atripla |
|
| Hypersensitivity reaction |
|
| Toxicity - GI tract |
|
| Toxicity - Pancreas |
|
| Toxicity, mainly from nervous system |
|
| Toxicity, mainly from kidneys |
|
| Side effects -any of the above unspecified |
|
| Co-morbidity |
|
| Simplified treatment available |
|
| Structured Treatment Interruption (STI) |
|
| Participant's wish/decision |
|
| Physician's decision |
|
| Non-compliance |
|
| Other causes |
|
| Unknown cause |
|
| Title | Measurements |
|---|---|
|
| Nervous system |
|
| Kidneys |
|
| Other side effects (not specified as above) |
|
| Title | Measurements |
|---|---|
|
| Severe hepatic events, n=0 |
|
| Death or hospitalization due to AIDS, n=1 |
|