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

February 24, 2010
July 22, 2014
December 2008
December 2017   (final data collection date for primary outcome measure)
To assess the tolerability of lopinavir/ritonavir in combination with new substances. [ Time Frame: Up to week 144 ] [ Designated as safety issue: No ]
Viral load, CD4/CD8 (cluster of differentiation 4/cluster of differentiation 8), resistance, quality of life, analysis of adverse events. [ Time Frame: Baseline, 4,12,24,36,48,60,72,84,96,108,120,132,144 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01076179 on ClinicalTrials.gov Archive Site
  • 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.
Characterization of resistance development through viral load and protease mutations [ Time Frame: After treatment failure ] [ Designated as safety issue: No ]
  • 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.
Not Provided
 
Kaletra in Combination With Antiretroviral Agents
KALETRA in Combination With New Substances

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community sample: Human Immunodeficiency Virus-positive patients

Human Immunodeficiency Virus
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
December 2017
December 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Bettina Koenig, PhD +49-6122-581062 bettina.koenig@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com
Germany
 
NCT01076179
P11-021
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP