An observational study in Human Immunodeficiency Virus, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-05-23.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 3,049 is above the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: * antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets * participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen * participants pretreated with a PI-containing regimen (apart from Kaletra).
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.
Time frame: Baseline (Week 0) to Week 144
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.
Time frame: Baseline (Week 0) to Week 144
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, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
Time frame: 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, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
Time frame: Weeks 0 to 144
| Milestone | HIV-infected Participants |
|---|---|
| Started | 3049 |
| Completed | 3039 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Subject documented twice | 1 |
| Withdrew: Did not meet inclusion criteria | 8 |
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.
| cells/μL | HIV-infected Participants |
|---|---|
| Change at Week 4 | 99.8 ± 145.2 |
| Change at Week 12 | 133.3 ± 148.7 |
| Change at Week 24 | 160.5 ± 177.6 |
| Change at Week 36 | 185.9 ± 181.2 |
| Change at Week 48 | 213.6 ± 225.1 |
| Change at Week 60 | 228.4 ± 204.6 |
| Change at Week 72 | 250.1 ± 205.1 |
| Change at Week 84 | 263.8 ± 214.8 |
| Change at Week 96 | 276.3 ± 212.8 |
| Change at Week 108 | 291.0 ± 247.6 |
| Change at Week 120 | 294.3 ± 216.5 |
| Change at Week 132 | 303.8 ± 229.3 |
| Change at Week 144 | 316.1 ± 228.2 |
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.
| log copies/mL | HIV-infected Participants |
|---|---|
| Change at Week 4 | -1.90 ± 0.97 |
| Change at Week 12 | -2.53 ± 1.23 |
| Change at Week 24 | -2.83 ± 1.35 |
| Change at Week 36 | -2.89 ± 1.40 |
| Change at Week 48 | -2.89 ± 1.41 |
| Change at Week 60 | -2.93 ± 1.38 |
| Change at Week 72 | -2.92 ± 1.36 |
| Change at Week 84 | -2.92 ± 1.37 |
| Change at Week 96 | -2.93 ± 1.38 |
| Change at Week 108 | -2.93 ± 1.39 |
| Change at Week 120 | -2.92 ± 1.36 |
| Change at Week 132 | -2.94 ± 1.36 |
| Change at Week 144 | -2.97 ± 1.34 |
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, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
| percentage of adverse events | HIV-infected Participants |
|---|---|
| Hypertriglyceridemia | 12.4 |
| Hypercholesterolemia | 19.3 |
| Low HDL Cholesterol | 0.5 |
| High LDL Cholesterol | 2.3 |
| Hyperglycemia | 3.0 |
| Hyperbilirubinemia | 2.7 |
| Elevated AST | 3.5 |
| Elevated ALT | 4.1 |
| Elevated γGT | 7.3 |
| Elevated Alkaline Phosphatase | 3.1 |
| Stomatitis | 0.6 |
| Nausea | 4.2 |
| Vomiting | 1.5 |
| Diarrhea | 18.3 |
| Abdominal Pain | 2.9 |
| Mood Disorder | 5.0 |
| Neurocerebellar Disorder | 0.6 |
| Neurocontrol Disorder | 0.0 |
| Headache | 1.9 |
| Fatigue | 4.0 |
| Fever | 1.4 |
| Not Specified | 4.8 |
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, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
| percentage of participants | HIV-infected Participants |
|---|---|
| Hypertriglyceridemia | 14.1 |
| Hypercholesterolemia | 16.3 |
| Low HDL Cholesterol | 1.6 |
| High LDL Cholesterol | 4.0 |
| Hyperglycemia | 5.8 |
| Hyperbilirubinemia | 3.9 |
| Elevated AST | 6.7 |
| Elevated ALT | 7.5 |
| Elevated γGT | 9.3 |
| Elevated Alkaline Phosphatase | 4.7 |
| Stomatitis | 2.0 |
| Nausea | 11.5 |
| Vomiting | 4.6 |
| Diarrhea | 32.7 |
| Abdominal Pain | 8.0 |
| Mood Disorder | 9.0 |
| Neurocerebellar Disorder | 1.7 |
| Neurocontrol Disorder | 0.0 |
| Headache | 5.2 |
| Fatigue | 8.7 |
| Fever | 4.4 |
| Not Specified | 30.4 |
Collected over Through Week 144. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIV-infected Participants | — | 79/3,039 (2.6%) | — |
| Event | HIV-infected Participants |
|---|---|
| DIARRHOEAGastrointestinal disorders | 6/3039 |
| ABDOMINAL PAINGastrointestinal disorders | 5/3039 |
| PYREXIAGeneral disorders | 5/3039 |
| PNEUMONIAInfections and infestations | 5/3039 |
| NAUSEAGastrointestinal disorders | 4/3039 |
| GENERAL PHYSICAL HEALTH DETERIORATIONGeneral disorders | 4/3039 |
| ANAEMIABlood and lymphatic system disorders | 3/3039 |
| VOMITINGGastrointestinal disorders | 3/3039 |
| PAINGeneral disorders | 3/3039 |
| LUMBAR VERTEBRAL FRACTUREInjury, poisoning and procedural complications | 3/3039 |
| Age, Continuous(years) | HIV-infected Participants |
|---|---|
| Mean | 40.7 ± 10.1 |
| Sex: Female, Male(Participants) | HIV-infected Participants |
|---|---|
| Female | 595 |
| Male | 2444 |
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
AbbVie (prior sponsor, Abbott)