Clinical trial NCT01076179: Kaletra in Combination With Antiretroviral Agents
Official title: KALETRA in Combination With New Substances (PROTEKT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Infection
Rilpivirine
CCR5 antagonists
Etravirine
Human Immunodeficiency Virus
Maraviroc
Safety and efficacy
Non nucleoside reverse transcriptase inhibitors (NNRTIs)
Integrase inhibitors
Raltegravir
Kaletra
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample: HIV-positive patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Adverse Events (Weeks 0-144), Per Event
timeFrame: Weeks 0 to 144
measure: Prevalence of Adverse Events (Weeks 0-144), Per Participant
timeFrame: Weeks 0 to 144
Secondary outcomes:
measure: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
timeFrame: Baseline (Week 0) to Week 144
measure: Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
timeFrame: Baseline (Week 0) to Week 144
measure: Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
timeFrame: Baseline (Week 0) to Week 144
measure: Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
timeFrame: From Week 0 to Week 144
measure: Number of Participants With Lopinavir (LPV) Resistance at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With LPV Resistance During Follow-Up
timeFrame: up to Week 144
measure: Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With PI Resistance During Follow-Up
timeFrame: Up to Week 144
measure: Number of Participants With INI Resistance at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With INI Resistance During Follow-Up
timeFrame: up to Week 144
measure: Number of Participants With NNRTI Resistance at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With NNRTI Resistance During Follow-Up
timeFrame: up to Week 144
measure: Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With NRTI Resistance During Follow-Up
timeFrame: up to Week 144
measure: Number of Participants With HIV-1 Coreceptor Tropism at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With HIV-1 Coreceptor Tropism During Follow-up
timeFrame: up to Week 144
Other outcomes:
measure: Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
timeFrame: Baseline (Week 0) to Week 144
measure: Time to Virologic Failure
timeFrame: Baseline (Week 0) to Week 144
Locations:
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Bianca Wittig, MD
role: STUDY_DIRECTOR
References: