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Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-infected participants | HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Absolute CD4 Cell Count | Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample; Human Immunodeficiency Virus-infected participants
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Simianer, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 48283 | Berlin | 10439 | Germany | |||
| Site Reference ID/Investigator# 28131 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV-infected Participants | HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV-infected Participants | HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | In 10 participants, age was missing. |
| 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 | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Number | percentage of participants | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
3 years
Serious Adverse Events (SAEs) and Adverse Events (AEs) were reported by the investigators using standard reporting forms and were sent directly to the sponsor's pharmacovigilance department.
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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 | HIV-infected Participants | HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily). Safety data presents all enrolled participants, including 5 protocol violations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urosepsis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| 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 |
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| Change From Baseline in Relative CD4 Cell Count | Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
| Change From Baseline in Absolute CD8 Cell Count | Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
| Change From Baseline in Relative CD8 Cell Count | Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
| Change From Baseline in CD4/CD8 T-cell Ratio | The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits. | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
| Berlin |
| 10551 |
| Germany |
| Site Reference ID/Investigator# 66422 | Berlin | 10961 | Germany |
| Site Reference ID/Investigator# 28123 | Berlin | 13347 | Germany |
| Site Reference ID/Investigator# 28109 | Berlin | D-10243 | Germany |
| Site Reference ID/Investigator# 28115 | Dortmund | 44137 | Germany |
| Site Reference ID/Investigator# 28124 | Frankfurt | 60311 | Germany |
| Site Reference ID/Investigator# 28127 | Frankfurt | 60329 | Germany |
| Site Reference ID/Investigator# 28119 | Frankfurt | 60596 | Germany |
| Site Reference ID/Investigator# 5318 | Krefeld | 47800 | Germany |
| Site Reference ID/Investigator# 28112 | Ludwigshafen | 67063 | Germany |
| Site Reference ID/Investigator# 28118 | Munich | 80337 | Germany |
| Site Reference ID/Investigator# 28113 | Munich | 80801 | Germany |
| Site Reference ID/Investigator# 28111 | Münster | 48143 | Germany |
| Site Reference ID/Investigator# 28129 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 28133 | Stuttgart | 70197 | Germany |
| Site Reference ID/Investigator# 28126 | Wuppertal | 42277 | Germany |
| Adverse Event |
|
| Noncompliance |
|
| Therapy Break |
|
| Patient's Wish |
|
| Unknown Reasons |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline in Absolute CD4 Cell Count | Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Mean | Standard Deviation | cells/µL | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
|
|
| Secondary | Change From Baseline in Relative CD4 Cell Count | Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Mean | Standard Deviation | percentage of cells | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
|
|
| Secondary | Change From Baseline in Absolute CD8 Cell Count | Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Mean | Standard Deviation | cells/µL | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
|
|
| Secondary | Change From Baseline in Relative CD8 Cell Count | Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Mean | Standard Deviation | percentage of cells | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
|
|
| Secondary | Change From Baseline in CD4/CD8 T-cell Ratio | The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits. | Evaluable participants. n=number of evaluable participants with given measurement at time point. | Posted | Mean | Standard Deviation | ratio | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 |
|
|
|
| 4 |
| 65 |
| 0 |
| 65 |
| Gastroenteritis clostridial | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Anal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment | leading to death |
|
Abbott 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. Abbott 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 Abbott 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 |
|---|---|
|
| Change at Week 24 (n=48) |
|
| Change at Week 36 (n=43) |
|
| Change at Week 48 (n=42) |
|
| Change at Week 60 (n=38) |
|
| Change at Week 72 (n=38) |
|
| Change at Week 84 (n=33) |
|
| Change at Week 96 (n=30) |
|
| Change at Week 108 (n=35) |
|
| Change at Week 120 (n=30) |
|
| Change at Week 132 (n=31) |
|
| Change at Week 144 (n=28) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 24 (n=42) |
|
| Change at Week 36 (n=38) |
|
| Change at Week 48 (n=35) |
|
| Change at Week 60 (n=32) |
|
| Change at Week 72 (n=32) |
|
| Change at Week 84 (n=28) |
|
| Change at Week 96 (n=24) |
|
| Change at Week 108 (n=28) |
|
| Change at Week 120 (n=24) |
|
| Change at Week 132 (n=25) |
|
| Change at Week 144 (n=23) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 24 (n=49) |
|
| Change at Week 36 (n=43) |
|
| Change at Week 48 (n=42) |
|
| Change at Week 60 (n=38) |
|
| Change at Week 72 (n=38) |
|
| Change at Week 84 (n=33) |
|
| Change at Week 96 (n=30) |
|
| Change at Week 108 (n=35) |
|
| Change at Week 120 (n=30) |
|
| Change at Week 132 (n=31) |
|
| Change at Week 144 (n=28) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 24 (n=42) |
|
| Change at Week 36 (n=38) |
|
| Change at Week 48 (n=35) |
|
| Change at Week 60 (n=32) |
|
| Change at Week 72 (n=31) |
|
| Change at Week 84 (n=28) |
|
| Change at Week 96 (n=24) |
|
| Change at Week 108 (n=28) |
|
| Change at Week 120 (n=24) |
|
| Change at Week 132 (n=25) |
|
| Change at Week 144 (n=23) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 24 (n=48) |
|
| Change at Week 36 (n=43) |
|
| Change at Week 48 (n=42) |
|
| Change at Week 60 (n=38) |
|
| Change at Week 72 (n=38) |
|
| Change at Week 84 (n=33) |
|
| Change at Week 96 (n=30) |
|
| Change at Week 108 (n=35) |
|
| Change at Week 120 (n=30) |
|
| Change at Week 132 (n=31) |
|
| Change at Week 144 (n=28) |
|