Kaletra in Combination With Antiretroviral Agents (PROTEKT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01076179
First received: February 24, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to investigate the tolerability of Lopinavir/ritonavir in combination with new substances.


Condition
Human Immunodeficiency Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: KALETRA in Combination With New Substances

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • To assess the tolerability of lopinavir/ritonavir in combination with new substances. [ Time Frame: Up to week 144 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with resistance against PI (protease inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Number of patients with resistance against PI (protease inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
  • Number of patients with resistance against INI (integrase inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Number of patients with resistance against INI (integrase inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
  • Number of patients with resistance against NNRTI (non-nucleoside reverse transcriptase inhibitor) [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Number of patients with resistance against NNRTI (non-nucleoside reverse transcriptase inhibitor) [ Time Frame: Termination ] [ Designated as safety issue: No ]
  • Number of patients with (partial) resistance to CCR5 antagonists [ Time Frame: Termination ] [ Designated as safety issue: No ]
  • Number of patients with (partial) resistance to CCR5 antagonists. [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Number of patients with (partial) resistance to CCR5 antagonists. [ Time Frame: Termination ] [ Designated as safety issue: No ]
  • Change in CD4 T-cell count [ Time Frame: From Week 0 to Week 144 ] [ Designated as safety issue: No ]
    Increases in CD4 (cluster of differentiation 4) T-lymphocyte count is a bio marker for antiretroviral treatment effectiveness in restoring immunological function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts will be assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled visits planned as part of routine care that are captured in this study.


Other Outcome Measures:
  • Change in time to virologic failure [ Time Frame: From week 0 to week 144 ] [ Designated as safety issue: No ]
    Time to virologic failure : The earliest occurrence of (a) HIV (human immunodeficiency virus)-1 RNA (ribonucleic acid) >400 cp/mL confirmed on two consecutive occasions after achieving at least one HIV-1 RNA <50 cp/mL, (b) HIV-1 RNA >400 cp/mL at the final on-study visit if the patient had previously experienced at least one HIV-1 RNA <50 cp/mL but subsequently did not have HIV-1 RNA >400 cp/mL on two consecutive occasions, or (c) Day 1 if the patient never achieved HIV-1 RNA <50 cp/mL during study participation.

  • Mean change in HIV-1 RNA viral load. [ Time Frame: From Week 0 to Week 144 ] [ Designated as safety issue: No ]
    The percentage of patients with HIV (human immunodeficiency virus)-1 RNA (ribonucleic acid) viral load (a) <50 cp/mL, (b) <400 cp/mL, and (c) <1,000 cp/mL will be summarized over time for the study as a whole, as well as for the ARV (antiretroviral)-naïve, NNRTI (non-nucleoside reverse transcriptase inhibitor)-experienced, and PI (protease inhibitor)-experienced subgroups. The percentage of patients with HIV-1 RNA viral load below a pre-specified threshold will be summarized over time using both an intent-to-treat (patients with incomplete treatment = failure) and an on-treatment method.


Estimated Enrollment: 450
Study Start Date: December 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV (human immunodeficiency virus)-infected patients
HIV (human immunodeficiency virus)-infected patients on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists

Detailed Description:

The Primary Objectives is to assess the tolerability of lopinavir/ritonavir in standard clinical setting.

The Secondary Objectives are to characterize the development of viral resistance and to assess the development of CD4 T-lymphocyte cell count.

All medications will be prescribed as per clinical practice. The Rationale is to document the safety, tolerability and clinical outcome of therapy regimens including lopinavir/ritonavir and new substances, such as INIs (integrase inhibitors, CCR5 (C-C chemokine receptor type 5) antagonists and new NNRTIs (non-nucleoside reverse transcriptase inhibitors) 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 lopinavir/ritonavir.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample: Human Immunodeficiency Virus-positive patients

Criteria

Inclusion Criteria:

- Patients (18 years and older) with Human Immunodeficiency Virus infection, patients on therapy with lopinavir/ritonavir and an integrase inhibitor or non nucleoside reverse transcriptase inhibitor or CCR5 antagonist for at least 12 weeks.

Exclusion Criteria:

  • Hypersensitivity against Kaletra or other ingredients or integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists.
  • Severe liver insufficiency.
  • No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076179

Contacts
Contact: Bettina Koenig, PhD +49-6122-581062 bettina.koenig@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com

  Show 83 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01076179     History of Changes
Other Study ID Numbers: P11-021
Study First Received: February 24, 2010
Last Updated: July 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AbbVie:
Integrase inhibitors
Kaletra
Maraviroc
Non nucleoside reverse transcriptase inhibitors (NNRTIs)
Human Immunodeficiency Virus
Infection
Rilpivirine
CCR5 antagonists
Etravirine
Raltegravir
Safety and efficacy

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Reverse Transcriptase Inhibitors
Integrase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014