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Long term observation of patients under lopinavir/ritonavir containing therapy
Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapy-naive | Patients who had not received prior antiretroviral drug therapy |
| |
| pre-treated | Patients that had previously received antiretroviral therapy, but are protease inhibitor naive |
| |
| non-B | Patients infected with non-B subtypes of HIV-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir (Kaletra) | Drug | 3 capsules 2xdaily or 2 tablets 2xdaily Kaletra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported. | Baseline and at any timepoint where testing is possible |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With HIV-1 RNA <50 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Simianer, MD | Abbott Germany, Medical Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 27706 | Aachen | 52062 | Germany | |||
| Site Ref # / Investigator 52972 |
Not provided
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Therapy-naive | Participants who had not received prior antiretroviral drug therapy. |
| FG001 | Pre-treated | Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup. | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup. | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| Percentage of Patients With HIV-1 RNA >500 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup. | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter. | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| Aachen |
| 52062 |
| Germany |
| Site Ref # / Investigator 27660 | Berlin | 10117 | Germany |
| Site Ref # / Investigator 27937 | Berlin | 10117 | Germany |
| Site Ref # / Investigator 52973 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 27629 | Berlin | 10243 | Germany |
| Site Ref # / Investigator 27651 | Berlin | 10439 | Germany |
| Site Ref # / Investigator 27912 | Berlin | 10439 | Germany |
| Site Reference ID/Investigator# 27544 | Berlin | 10439 | Germany |
| Site Reference ID/Investigator# 27567 | Berlin | 10551 | Germany |
| Site Ref # / Investigator 27929 | Berlin | 10589 | Germany |
| Site Ref # / Investigator 52971 | Berlin | 10707 | Germany |
| Site Ref # / Investigator 53468 | Berlin | 10707 | Germany |
| Site Ref # / Investigator 27965 | Berlin | 10777 | Germany |
| Site Reference ID/Investigator# 27547 | Berlin | 10777 | Germany |
| Site Reference ID/Investigator# 27552 | Berlin | 10777 | Germany |
| Site Reference ID/Investigator# 27562 | Berlin | 10777 | Germany |
| Site Ref # / Investigator 52984 | Berlin | 10961 | Germany |
| Site Ref # / Investigator 27639 | Berlin | 13347 | Germany |
| Site Ref # / Investigator 52970 | Berlin | 13347 | Germany |
| Site Ref # / Investigator 27909 | Berlin | D-10243 | Germany |
| Site Ref # / Investigator 47113 | Berlin | D-10243 | Germany |
| Site Reference ID/Investigator# 27574 | Chemnitz | 09113 | Germany |
| Site Ref # / Investigator 28060 | Cologne | 50674 | Germany |
| Site Ref # / Investigator 52978 | Cologne | 50674 | Germany |
| Site Ref # / Investigator 27932 | Cologne | 50679 | Germany |
| Site Ref # / Investigator 52979 | Cologne | 50679 | Germany |
| Site Ref # / Investigator 48233 | Cologne | 50931 | Germany |
| Site Ref # / Investigator 52985 | Cologne | 50931 | Germany |
| Site Ref # / Investigator 53464 | Cologne | 50931 | Germany |
| Site Ref # / Investigator 27704 | Dortmund | 44137 | Germany |
| Site Ref # / Investigator 27947 | Dortmund | 44137 | Germany |
| Site Ref # / Investigator 52968 | Dortmund | 44137 | Germany |
| Site Reference ID/Investigator# 27558 | Duisburg | 47259 | Germany |
| Site Ref # / Investigator 28056 | Düsseldorf | 40237 | Germany |
| Site Ref # / Investigator 52983 | Frankfurt | 15232 | Germany |
| Site Ref # / Investigator 27928 | Frankfurt | 60311 | Germany |
| Site Ref # / Investigator 52967 | Frankfurt | 60311 | Germany |
| Site Reference ID/Investigator# 27565 | Freiburg im Breisgau | 79106 | Germany |
| Site Reference ID/Investigator# 27566 | Fürth | 90762 | Germany |
| Site Ref # / Investigator 53465 | Fürth | D-90762 | Germany |
| Site Ref # / Investigator 27931 | Hamburg | 20099 | Germany |
| Site Ref # / Investigator 27982 | Hamburg | 20099 | Germany |
| Site Ref # / Investigator 47114 | Hamburg | 20099 | Germany |
| Site Ref # / Investigator 47115 | Hamburg | 20099 | Germany |
| Site Reference ID/Investigator# 27551 | Hamburg | 20099 | Germany |
| Site Reference ID/Investigator# 27634 | Hamburg | 20099 | Germany |
| Site Ref # / Investigator 30864 | Hamburg | 20146 | Germany |
| Site Ref # / Investigator 5348 | Hamburg | 20146 | Germany |
| Site Reference ID/Investigator# 27546 | Hamburg | 20146 | Germany |
| Site Ref # / Investigator 28032 | Hamburg | 20246 | Germany |
| Site Ref # / Investigator 52969 | Hamburg | 20246 | Germany |
| Site Ref # / Investigator 53467 | Hamburg | 20246 | Germany |
| Site Ref # / Investigator 52980 | Hamburg | 20354 | Germany |
| Site Ref # / Investigator 27641 | Karlsruhe | 76135 | Germany |
| Site Ref # / Investigator 27964 | Karlsruhe | 76135 | Germany |
| Site Reference ID/Investigator# 27561 | Karlsruhe | 76135 | Germany |
| Site Ref # / Investigator 53466 | Koblenz | 56065 | Germany |
| Site Reference ID/Investigator# 27555 | Koblenz | 56065 | Germany |
| Site Ref # / Investigator 27905 | Krefeld | 47800 | Germany |
| Site Ref # / Investigator 27906 | Leipzig | 04107 | Germany |
| Site Ref # / Investigator 52975 | Leipzig | 04107 | Germany |
| Site Ref # / Investigator 53463 | Leipzig | 04107 | Germany |
| Site Ref # / Investigator 27948 | Ludwigshafen | 67063 | Germany |
| Site Ref # / Investigator 52977 | Ludwigshafen | 67063 | Germany |
| Site Ref # / Investigator 27902 | Mainz | 55116 | Germany |
| Site Reference ID/Investigator# 27543 | Mainz | 55116 | Germany |
| Site Ref # / Investigator 28104 | Mönchengladbach | 41061 | Germany |
| Site Ref # / Investigator 52981 | Mönchengladbach | 41061 | Germany |
| Site Ref # / Investigator 27949 | Munich | 80337 | Germany |
| Site Reference ID/Investigator# 27553 | Munich | 80337 | Germany |
| Site Ref # / Investigator 27926 | Munich | 80801 | Germany |
| Site Ref # / Investigator 53462 | Munich | 80801 | Germany |
| Site Ref # / Investigator 27648 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 27568 | Münster | 48149 | Germany |
| Site Ref # / Investigator 52982 | Nuremberg | 90419 | Germany |
| Site Ref # / Investigator 27988 | Oldenburg | 26121 | Germany |
| Site Reference ID/Investigator# 27563 | Oldenburg | 26121 | Germany |
| Site Ref # / Investigator 27637 | Osnabrück | 49076 | Germany |
| Site Ref # / Investigator 27943 | Osnabrück | 49076 | Germany |
| Site Ref # / Investigator 52974 | Osnabrück | 49076 | Germany |
| Site Ref # / Investigator 27939 | Paderborn | 33100 | Germany |
| Site Ref # / Investigator 27649 | Rostock | 18057 | Germany |
| Site Reference ID/Investigator# 27569 | Rostock | D-18057 | Germany |
| Site Ref # / Investigator 27647 | Stuttgart | 70197 | Germany |
| Site Ref # / Investigator 28047 | Stuttgart | 70197 | Germany |
| Site Ref # / Investigator 28048 | Stuttgart | 70197 | Germany |
| Site Reference ID/Investigator# 27631 | Stuttgart | 70197 | Germany |
| Site Ref # / Investigator 52976 | Troisdorf | 53840 | Germany |
| Site Ref # / Investigator 27961 | Wuppertal | 42277 | Germany |
| FG002 | Non-B | Participants infected with non-B subtypes of HIV-1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Therapy-naive | Participants who had not received prior antiretroviral drug therapy. |
| BG001 | Pre-treated | Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. |
| BG002 | Non-B | Participants infected with non-B subtypes of HIV-1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs | Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported. | All participants with resistance testing at baseline and follow-up are presented. | Posted | Number | Participants | Baseline and at any timepoint where testing is possible |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HIV-1 RNA <50 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup. | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Posted | Number | Percentage of participants | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup. | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Posted | Number | Percentage of participants | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup. | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Posted | Number | Percentage of participants | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HIV-1 RNA >500 Copies/ml | All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup. | All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure. | Posted | Number | Percentage of participants | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] | The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter. | All participants with CD4+ measurements at Baseline and any subsequent time point are included. | Posted | Mean | Standard Deviation | CD4+ cells/µL | Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks |
|
Investigators were instructed to report adverse events throughout the study (up to 5 years).
Three studies in different populations of participants with HIV-1 infection were conducted in parallel: KAL1RO (NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55). Safety data were collected in a manner that prevented separate analyses for each study, therefore pooled safety data (n=284) are shown.
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 Patients | Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55). | 16 | 284 | 56 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Weight loss | Metabolism and nutrition disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Ataxia left leg | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Paralysis left upper extremity | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Paralysis of left side of face | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Fall | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Stupor | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Thickening of meninges | Nervous system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Lung carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Malignant lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Brain metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Lymph nodes enlarged | Blood and lymphatic system disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Common cold | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Myobacterium avium | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Myobacterium kansaii | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Pneumocystis pneumonia | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Mediastinitis | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Polyserositis | Infections and infestations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Lumbosacral syndrome | Musculoskeletal and connective tissue disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Gallstones | Hepatobiliary disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Liver damage | Hepatobiliary disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Icterus | Hepatobiliary disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Deep venous thrombosis femoral | Vascular disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Pulmonary artery thrombosis | Vascular disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Peripheral edema | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Somnolence | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Night sweats | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Reduced general condition | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Shivering | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Fever | General disorders | Raw (uncoded) terms | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Raw (uncoded) terms | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | Raw (uncoded) terms | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
| Male |
|
| Gender not reported |
|
|
| >Resistance to lopinavir/ritonavir at Baseline |
|
| >Partial resistance to NRTI at Baseline |
|
| >Partial resistance to NNRTI at Baseline |
|
| Underwent resistance testing at follow-up |
|
| >Resistance to lopinavir/ritonavir* |
|
| >>Resistance to NRTIs |
|
| >>Resistance to NNRTIs |
|
| *No baseline results avail for this participant |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|