Evaluation of Kaletra Therapy Over the Long-term
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01083810
First received: February 26, 2010
Last updated: August 9, 2011
Last verified: August 2011
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Results First Received: June 30, 2011
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Only; Time Perspective: Prospective |
| Condition: |
Human Immunodeficiency Virus |
| Intervention: |
Drug: Lopinavir/Ritonavir (Kaletra) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Therapy-naive | Participants who had not received prior antiretroviral drug therapy. |
| Pre-treated | Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. |
| Non-B | Participants infected with non-B subtypes of HIV-1. |
Participant Flow: Overall Study
| Therapy-naive | Pre-treated | Non-B | |
|---|---|---|---|
| STARTED | 137 | 92 | 55 |
| COMPLETED | 72 | 47 | 35 |
| NOT COMPLETED | 65 | 45 | 20 |
| Lost to Follow-up | 23 | 11 | 4 |
| Adverse Event | 15 | 11 | 4 |
| Withdrawal by Subject | 7 | 2 | 4 |
| Reason not reported | 6 | 1 | 1 |
| Non-compliance | 4 | 7 | 2 |
| Simplification | 4 | 1 | 0 |
| Death | 2 | 2 | 3 |
| Co-morbidities | 1 | 0 | 0 |
| Participation in study | 1 | 0 | 0 |
| Therapy break | 1 | 2 | 2 |
| Virologic failure | 1 | 8 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Therapy-naive | Participants who had not received prior antiretroviral drug therapy. |
| Pre-treated | Participants that had previously received antiretroviral therapy, but were protease inhibitor naive. |
| Non-B | Participants infected with non-B subtypes of HIV-1. |
| Total | Total of all reporting groups |
Baseline Measures
| Therapy-naive | Pre-treated | Non-B | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
137 | 92 | 55 | 284 |
|
Age, Customized
[units: Participants] |
||||
| >= 18 years of age (exact age not reported) | 137 | 92 | 55 | 284 |
|
Gender, Customized
[units: Participants] |
||||
| Female | 17 | 11 | 20 | 48 |
| Male | 119 | 81 | 35 | 235 |
| Gender not reported | 1 | 0 | 0 | 1 |
|
Region of Enrollment
[units: participants] |
||||
| Germany | 137 | 92 | 55 | 284 |
Outcome Measures
| 1. Primary: | Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs [ Time Frame: Baseline and at any timepoint where testing is possible ] |
| 2. Secondary: | Percentage of Patients With HIV-1 RNA <50 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] |
| 3. Secondary: | Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] |
| 4. Secondary: | Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] |
| 5. Secondary: | Percentage of Patients With HIV-1 RNA >500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] |
| 6. Secondary: | Change in Absolute CD4 Cell Count [CD4+ Cells/µL] [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ] |