HIV-1 Infection
Conditions
Keywords
Postmarketing Drug Surveillance, HIV-1 infection, Kaletra
Brief summary
This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1) infection.
Detailed description
Participants were observed for up to 48 weeks following the first dose of Kaletra. A follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients 2 years of age and above with HIV-1 infection * Patients who were prescribed Kaletra treatment as per investigator's medical judgment * Patients who gave verbal or written authorization to use their personal and health data * Patients who started Kaletra treatment after study agreement was in place
Exclusion criteria
* Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the Kaletra tablet * Patients who were being treated or will be treated with drugs that are contraindicated with Kaletra * Patients who have been treated with Kaletra * Patients participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Viral Load Below 50 Copies/mL | Week 48 | Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. |
| Number of Participants With Adverse Events | From the start of treatment until 30 days after the last dose, up to 52 weeks | Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose. |
| Number of Participants Who Interrupted or Discontinued Kaletra Treatment | Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment | At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc). |
| Percentage of Participants With Viral Load Below 400 Copies/mL | Week 24 | Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Viral Load | Week 24 & 48 | This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated. |
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts | From baseline to Weeks 24 and 48 | Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks. |
| Percentage of Participants With Confirmed Viral Resistance | From baseline through weeks 24 and 48 | Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance. |
| Mean Time to Treatment Failure | From baseline through weeks 24 and 48 | Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level \> 400 copies/mL at week 24 and HIV RNA level \> 50 copies/mL at week 48. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks. | 580 |
| Total | 580 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Long-term Surveillance: Effectiveness Gr | Administration of Kaletra <48 wks | 0 | 46 |
| Long-term Surveillance: Effectiveness Gr | No follow-up at 48 ±4 wks | 0 | 195 |
| Long-term Surveillance: Effectiveness Gr | No viral load data at 48 ±4 wks | 0 | 136 |
| Long-term Surveillance: Safety Group | Administration of Kaletra <20 wks | 0 | 101 |
| Long-term Surveillance: Safety Group | Violation of inclusion/exclusion crit. | 0 | 14 |
| Long-term Surveillance: Safety Group | Violation of the dosage | 0 | 1 |
| Main Surveillance: Effectiveness Group | Administration of Kaletra <24 wks | 13 | 0 |
| Main Surveillance: Effectiveness Group | No follow-up at 24 ±4 wks | 201 | 0 |
| Main Surveillance: Effectiveness Group | No viral load data at 24 ±4 wks | 168 | 0 |
| Main Surveillance: Safety Group | Violation of inclusion/exclusion crit. | 14 | 0 |
| Main Surveillance: Safety Group | Violation of the use/dosage | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Customized Long-term Surveillance n=479 | 41 years STANDARD_DEVIATION 12.1 |
| Age, Customized Main Surveillance n= 580 | 41.3 years STANDARD_DEVIATION 12.5 |
| Sex/Gender, Customized Long-Term Surveillance Females | 47 participants |
| Sex/Gender, Customized Long-Term Surveillance Males | 432 participants |
| Sex/Gender, Customized Main Surveillance Females | 56 participants |
| Sex/Gender, Customized Main Surveillance Males | 524 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 222 / 580 | 169 / 479 |
| serious Total, serious adverse events | 51 / 580 | 39 / 479 |
Outcome results
Primary
Number of Participants Who Interrupted or Discontinued Kaletra Treatment
At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).
Time frame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
Population: Participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Surveillance | Number of Participants Who Interrupted or Discontinued Kaletra Treatment | 120 participants |
| Long-term Surveillance | Number of Participants Who Interrupted or Discontinued Kaletra Treatment | 43 participants |
Primary
Number of Participants With Adverse Events
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Time frame: From the start of treatment until 30 days after the last dose, up to 52 weeks
Population: Participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Surveillance | Number of Participants With Adverse Events | 363 participants |
| Long-term Surveillance | Number of Participants With Adverse Events | 285 participants |
Primary
Percentage of Participants With Viral Load Below 400 Copies/mL
Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Time frame: Week 24
Population: Participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Surveillance | Percentage of Participants With Viral Load Below 400 Copies/mL | 92.4 percentage of participants |
Primary
Percentage of Participants With Viral Load Below 50 Copies/mL
Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Time frame: Week 48
Population: Participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Surveillance | Percentage of Participants With Viral Load Below 50 Copies/mL | 68.6 percentage of participants |
Secondary
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.
Time frame: From baseline to Weeks 24 and 48
Population: Participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Surveillance | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts | 145.47 cells/mm˄3 | Standard Deviation 144.28 |
| Long-term Surveillance | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts | 170.47 cells/mm˄3 | Standard Deviation 159.3 |
Comparison: CD4 cell counts at 24 weeks as compared to baselinep-value: <0.0001Paired t-test
Comparison: CD4 cell counts at 48 weeks as compared to baselinep-value: <0.0001Paired t-test
Secondary
Change From Baseline in Viral Load
This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.
Time frame: Week 24 & 48
Secondary
Mean Time to Treatment Failure
Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level \> 400 copies/mL at week 24 and HIV RNA level \> 50 copies/mL at week 48.
Time frame: From baseline through weeks 24 and 48
Population: Participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Surveillance | Mean Time to Treatment Failure | 399.97 days | Standard Error 3.45 |
| Long-term Surveillance | Mean Time to Treatment Failure | 410.8 days | Standard Error 1.03 |
Secondary
Percentage of Participants With Confirmed Viral Resistance
Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.
Time frame: From baseline through weeks 24 and 48
Population: Participants with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Surveillance | Percentage of Participants With Confirmed Viral Resistance | 0.51 percentage of participants |
| Long-term Surveillance | Percentage of Participants With Confirmed Viral Resistance | 1.96 percentage of participants |