Evaluation of Kaletra Therapy Over the Long-term
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Drug: Lopinavir/Ritonavir (Kaletra)
- Registration Number
- NCT01083810
- Lead Sponsor
- Abbott
- Brief Summary
Long term observation of patients under lopinavir/ritonavir containing therapy
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- Patients infected by HIV-1
- Age greater than or equal to 18 years
- as described in SmPC (summary of product characteristics) at the time of prescription
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description therapy-naive Lopinavir/Ritonavir (Kaletra) Patients who had not received prior antiretroviral drug therapy pre-treated Lopinavir/Ritonavir (Kaletra) Patients that had previously received antiretroviral therapy, but are protease inhibitor naive non-B Lopinavir/Ritonavir (Kaletra) Patients infected with non-B subtypes of HIV-1
- Primary Outcome Measures
Name Time Method Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs Baseline and at any timepoint where testing is possible 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With HIV-1 RNA <50 Copies/ml Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks 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.
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks 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.
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks 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.
Percentage of Patients With HIV-1 RNA >500 Copies/ml Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks 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.
Change in Absolute CD4 Cell Count [CD4+ Cells/µL] Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks 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.
Trial Locations
- Locations (90)
Site Ref # / Investigator 52972
🇩🇪Aachen, Germany
Site Reference ID/Investigator# 27629
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 27562
🇩🇪Berlin, Germany
Site Ref # / Investigator 27660
🇩🇪Berlin, Germany
Site Ref # / Investigator 27937
🇩🇪Berlin, Germany
Site Ref # / Investigator 27706
🇩🇪Aachen, Germany
Site Reference ID/Investigator# 27544
🇩🇪Berlin, Germany
Site Ref # / Investigator 27929
🇩🇪Berlin, Germany
Site Ref # / Investigator 52984
🇩🇪Berlin, Germany
Site Ref # / Investigator 27639
🇩🇪Berlin, Germany
Site Ref # / Investigator 52970
🇩🇪Berlin, Germany
Site Ref # / Investigator 27965
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 27567
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 27547
🇩🇪Berlin, Germany
Site Ref # / Investigator 53468
🇩🇪Berlin, Germany
Site Ref # / Investigator 52983
🇩🇪Frankfurt, Germany
Site Ref # / Investigator 52985
🇩🇪Cologne, Germany
Site Reference ID/Investigator# 27552
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 27574
🇩🇪Chemnitz, Germany
Site Ref # / Investigator 28060
🇩🇪Cologne, Germany
Site Ref # / Investigator 52978
🇩🇪Cologne, Germany
Site Ref # / Investigator 27932
🇩🇪Cologne, Germany
Site Ref # / Investigator 52979
🇩🇪Cologne, Germany
Site Ref # / Investigator 27704
🇩🇪Dortmund, Germany
Site Reference ID/Investigator# 27551
🇩🇪Hamburg, Germany
Site Ref # / Investigator 27909
🇩🇪Berlin, Germany
Site Ref # / Investigator 27651
🇩🇪Berlin, Germany
Site Ref # / Investigator 52971
🇩🇪Berlin, Germany
Site Ref # / Investigator 52973
🇩🇪Berlin, Germany
Site Ref # / Investigator 47113
🇩🇪Berlin, Germany
Site Ref # / Investigator 27947
🇩🇪Dortmund, Germany
Site Ref # / Investigator 48233
🇩🇪Cologne, Germany
Site Ref # / Investigator 53464
🇩🇪Cologne, Germany
Site Ref # / Investigator 28056
🇩🇪Duesseldorf, Germany
Site Ref # / Investigator 27928
🇩🇪Frankfurt, Germany
Site Reference ID/Investigator# 27565
🇩🇪Freiburg, Germany
Site Ref # / Investigator 52967
🇩🇪Frankfurt, Germany
Site Ref # / Investigator 27982
🇩🇪Hamburg, Germany
Site Ref # / Investigator 27931
🇩🇪Hamburg, Germany
Site Reference ID/Investigator# 27566
🇩🇪Fuerth, Germany
Site Ref # / Investigator 53465
🇩🇪Fuerth, Germany
Site Ref # / Investigator 47114
🇩🇪Hamburg, Germany
Site Ref # / Investigator 28032
🇩🇪Hamburg, Germany
Site Ref # / Investigator 52969
🇩🇪Hamburg, Germany
Site Ref # / Investigator 30864
🇩🇪Hamburg, Germany
Site Reference ID/Investigator# 27546
🇩🇪Hamburg, Germany
Site Ref # / Investigator 52980
🇩🇪Hamburg, Germany
Site Ref # / Investigator 53467
🇩🇪Hamburg, Germany
Site Ref # / Investigator 27641
🇩🇪Karlsruhe, Germany
Site Ref # / Investigator 27964
🇩🇪Karlsruhe, Germany
Site Reference ID/Investigator# 27561
🇩🇪Karlsruhe, Germany
Site Ref # / Investigator 52975
🇩🇪Leipzig, Germany
Site Ref # / Investigator 27906
🇩🇪Leipzig, Germany
Site Ref # / Investigator 53466
🇩🇪Koblenz, Germany
Site Ref # / Investigator 27905
🇩🇪Krefeld, Germany
Site Ref # / Investigator 27948
🇩🇪Ludwigshafen, Germany
Site Reference ID/Investigator# 27555
🇩🇪Koblenz, Germany
Site Ref # / Investigator 53463
🇩🇪Leipzig, Germany
Site Ref # / Investigator 52977
🇩🇪Ludwigshafen, Germany
Site Ref # / Investigator 27902
🇩🇪Mainz, Germany
Site Reference ID/Investigator# 27543
🇩🇪Mainz, Germany
Site Ref # / Investigator 28104
🇩🇪Moenchengladbach, Germany
Site Ref # / Investigator 27648
🇩🇪Muenster, Germany
Site Ref # / Investigator 52981
🇩🇪Moenchengladbach, Germany
Site Reference ID/Investigator# 27568
🇩🇪Muenster, Germany
Site Ref # / Investigator 27949
🇩🇪Munich, Germany
Site Reference ID/Investigator# 27553
🇩🇪Munich, Germany
Site Ref # / Investigator 27926
🇩🇪Munich, Germany
Site Ref # / Investigator 53462
🇩🇪Munich, Germany
Site Ref # / Investigator 52982
🇩🇪Nuernberg, Germany
Site Reference ID/Investigator# 27563
🇩🇪Oldenburg, Germany
Site Ref # / Investigator 27988
🇩🇪Oldenburg, Germany
Site Ref # / Investigator 27939
🇩🇪Paderborn, Germany
Site Ref # / Investigator 27637
🇩🇪Osnabrueck, Germany
Site Ref # / Investigator 52974
🇩🇪Osnabrueck, Germany
Site Ref # / Investigator 27943
🇩🇪Osnabrueck, Germany
Site Ref # / Investigator 27649
🇩🇪Rostock, Germany
Site Reference ID/Investigator# 27569
🇩🇪Rostock, Germany
Site Ref # / Investigator 27647
🇩🇪Stuttgart, Germany
Site Ref # / Investigator 28047
🇩🇪Stuttgart, Germany
Site Ref # / Investigator 27961
🇩🇪Wuppertal, Germany
Site Ref # / Investigator 28048
🇩🇪Stuttgart, Germany
Site Ref # / Investigator 52976
🇩🇪Troisdorf, Germany
Site Reference ID/Investigator# 27631
🇩🇪Stuttgart, Germany
Site Ref # / Investigator 47115
🇩🇪Hamburg, Germany
Site Ref # / Investigator 5348
🇩🇪Hamburg, Germany
Site Ref # / Investigator 27912
🇩🇪Berlin, Germany
Site Reference ID/Investigator# 27634
🇩🇪Hamburg, Germany
Site Reference ID/Investigator# 27558
🇩🇪Duisburg, Germany
Site Ref # / Investigator 52968
🇩🇪Dortmund, Germany