Kaletra in Combination With Antiretroviral Agents (PROTEKT)

AbbVie

Status: Completed

Conditions: Human Immunodeficiency Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT01076179

P11-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

502 participants in 1 patient group

Human Immunodeficiency Virus (HIV)-Infected Participants

Description:

HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists