Kaletra in Combination With Antiretroviral Agents

NCT01076179 | Completed Results

• 1 other identifier: P11-021
• Study Type: observational
• Target: 502
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Prevalence of Adverse Events (Weeks 0-144), Per Event

  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').

  Weeks 0 to 144

• Prevalence of Adverse Events (Weeks 0-144), Per Participant

  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').

  Weeks 0 to 144

Secondary Outcomes (16)

• Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count

  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, 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

• Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL

  From Week 0 to Week 144

• Number of Participants With Lopinavir (LPV) Resistance at Baseline

  Baseline (Week 0)

Other Outcomes (2)

• Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load

  Baseline (Week 0) to Week 144

• Time to Virologic Failure

  Baseline (Week 0) to Week 144

Study Arms (1)

Human Immunodeficiency Virus (HIV)-Infected Participants

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample: HIV-positive patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

800-633-9110

Study Officials

• Bianca Wittig, MD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: September 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-05