Evaluation of Kaletra Therapy Over the Long-term
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 284
- Locations
- 90
- Primary Endpoint
- Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients infected by HIV-1
- •Age greater than or equal to 18 years
Exclusion Criteria
- •as described in SmPC (summary of product characteristics) at the time of prescription
Arms & Interventions
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Intervention: Lopinavir/Ritonavir (Kaletra) (Drug)
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Intervention: Lopinavir/Ritonavir (Kaletra) (Drug)
non-B
Patients infected with non-B subtypes of HIV-1
Intervention: Lopinavir/Ritonavir (Kaletra) (Drug)
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)
- 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)
- 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)
- 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)
- Change in Absolute CD4 Cell Count [CD4+ Cells/µL](Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)