KALETRA in Combination With New Substances (PROTEKT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 502
- Primary Endpoint
- Prevalence of Adverse Events (Weeks 0-144), Per Participant
Study Overview
Brief Summary
The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 18years of age
- •Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
- •HIV-1 infection
- •Patients treated with KALETRA®, independent from their participation in this study
- •Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study
Exclusion Criteria
- •Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
- •Severe liver insufficiency
- •No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort
Outcomes
Primary Outcomes
Prevalence of Adverse Events (Weeks 0-144), Per Participant
Time Frame: Weeks 0 to 144
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, headache, fatigue, fever, other (listed as 'not specified').
Prevalence of Adverse Events (Weeks 0-144), Per Event
Time Frame: Weeks 0 to 144
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, headache, fatigue, fever, other (listed as 'not specified').
Secondary Outcomes
- Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count(Baseline (Week 0) to Week 144)
- Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL(From Week 0 to Week 144)
- Number of Participants With INI Resistance at Baseline(Baseline (Week 0))
- Number of Participants With NNRTI Resistance at Baseline(Baseline (Week 0))
- Number of Participants With NNRTI Resistance During Follow-Up(up to Week 144)
- Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis(Baseline (Week 0) to Week 144)
- Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis(Baseline (Week 0) to Week 144)
- Number of Participants With Lopinavir (LPV) Resistance at Baseline(Baseline (Week 0))
- Number of Participants With LPV Resistance During Follow-Up(up to Week 144)
- Number of Participants With PI Resistance During Follow-Up(Up to Week 144)
- Number of Participants With INI Resistance During Follow-Up(up to Week 144)
- Number of Participants With HIV-1 Coreceptor Tropism at Baseline(Baseline (Week 0))
- Number of Participants With HIV-1 Coreceptor Tropism During Follow-up(up to Week 144)
- Number of Participants With Protease Inhibitor (PI) Resistance at Baseline(Baseline (Week 0))
- Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline(Baseline (Week 0))
- Number of Participants With NRTI Resistance During Follow-Up(up to Week 144)