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

  Hide Study Locations
Locations
Germany
Site Reference ID/Investigator# 28222 Withdrawn
Aachen, Germany, 52062
Site Reference ID/Investigator# 28228 Recruiting
Aachen, Germany, 52062
Principal Investigator: Site Reference ID/Investigator# 28228         
Site Reference ID/Investigator# 28195 Recruiting
Berlin, Germany, 10627
Principal Investigator: Site Reference ID/Investigator# 28195         
Site Reference ID/Investigator# 47156 Withdrawn
Berlin, Germany, 10405
Site Reference ID/Investigator# 28249 Recruiting
Berlin, Germany, 13347
Principal Investigator: Site Reference ID/Investigator# 28249         
Site Reference ID/Investigator# 28254 Withdrawn
Berlin, Germany, 10777
Site Reference ID/Investigator# 30764 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 30764         
Site Reference ID/Investigator# 28198 Withdrawn
Berlin, Germany, 10405
Site Reference ID/Investigator# 28183 Recruiting
Berlin, Germany, 10439
Principal Investigator: Site Reference ID/Investigator# 28183         
Site Reference ID/Investigator# 30763 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 30763         
Site Reference ID/Investigator# 30762 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 30762         
Site Reference ID/Investigator# 28244 Recruiting
Berlin, Germany, 10777
Principal Investigator: Site Reference ID/Investigator# 28244         
Site Reference ID/Investigator# 28191 Recruiting
Berlin, Germany, 10969
Principal Investigator: Site Reference ID/Investigator# 28191         
Site Reference ID/Investigator# 28185 Recruiting
Berlin, Germany, 10243
Principal Investigator: Site Reference ID/Investigator# 28185         
Site Reference ID/Investigator# 28182 Recruiting
Berlin, Germany, 10719
Principal Investigator: Site Reference ID/Investigator# 28182         
Site Reference ID/Investigator# 28253 Recruiting
Berlin, Germany, 10551
Principal Investigator: Site Reference ID/Investigator# 28253         
Site Reference ID/Investigator# 28229 Recruiting
Berlin, Germany, 10961
Principal Investigator: Site Reference ID/Investigator# 28229         
Site Reference ID/Investigator# 99779 Recruiting
Berlin, Germany, 10969
Principal Investigator: Site Reference ID/Investigator# 99779         
Site Reference ID/Investigator# 28205 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 28205         
Site Reference ID/Investigator# 28243 Recruiting
Berlin, Germany, 10178
Principal Investigator: Site Reference ID/Investigator# 28243         
Site Reference ID/Investigator# 28199 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 28199         
Site Reference ID/Investigator# 28260 Recruiting
Berlin, Germany, 10707
Principal Investigator: Site Reference ID/Investigator# 28260         
Site Reference ID/Investigator# 63682 Recruiting
Berlin, Germany, 10243
Principal Investigator: Site Reference ID/Investigator# 63682         
Site Reference ID/Investigator# 47155 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 47155         
Site Reference ID/Investigator# 28186 Withdrawn
Bochum, Germany, D-44791
Site Reference ID/Investigator# 63684 Not yet recruiting
Bremen, Germany, 28779
Principal Investigator: Site Reference ID/Investigator# 63684         
Site Reference ID/Investigator# 28224 Recruiting
Bremen, Germany, 28203
Principal Investigator: Site Reference ID/Investigator# 28224         
Site Reference ID/Investigator# 28245 Withdrawn
Cologne, Germany, 50679
Site Reference ID/Investigator# 28252 Recruiting
Cologne, Germany, 50674
Principal Investigator: Site Reference ID/Investigator# 28252         
Site Reference ID/Investigator# 28184 Recruiting
Dortmund, Germany, 44145
Principal Investigator: Site Reference ID/Investigator# 28184         
Site Reference ID/Investigator# 28223 Recruiting
Dortmund, Germany, 44137
Principal Investigator: Site Reference ID/Investigator# 28223         
Site Reference ID/Investigator# 63685 Recruiting
Duesseldorf, Germany, 40227
Principal Investigator: Site Reference ID/Investigator# 63685         
Site Reference ID/Investigator# 28188 Recruiting
Duesseldorf, Germany, 40223
Principal Investigator: Site Reference ID/Investigator# 28188         
Site Reference ID/Investigator# 28250 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 28250         
Site Reference ID/Investigator# 125778 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 125778         
Site Reference ID/Investigator# 28231 Recruiting
Duisburg, Germany, 47259
Principal Investigator: Site Reference ID/Investigator# 28231         
Site Reference ID/Investigator# 28194 Recruiting
Essen, Germany, 45122
Principal Investigator: Site Reference ID/Investigator# 28194         
Site Reference ID/Investigator# 28227 Recruiting
Frankfurt, Germany, 60596
Principal Investigator: Site Reference ID/Investigator# 28227         
Site Reference ID/Investigator# 28233 Recruiting
Frankfurt, Germany, 60311
Principal Investigator: Site Reference ID/Investigator# 28233         
Site Reference ID/Investigator# 54202 Recruiting
Frankfurt am Main, Germany, 60590
Principal Investigator: Site Reference ID/Investigator# 54202         
Site Reference ID/Investigator# 28246 Recruiting
Freiburg, Germany, 79098
Principal Investigator: Site Reference ID/Investigator# 28246         
Site Reference ID/Investigator# 28258 Recruiting
Freiburg, Germany, 79106
Principal Investigator: Site Reference ID/Investigator# 28258         
Site Reference ID/Investigator# 28251 Recruiting
Fuerth, Germany, D-90762
Principal Investigator: Site Reference ID/Investigator# 28251         
Site Reference ID/Investigator# 28193 Recruiting
Giessen, Germany, 35392
Principal Investigator: Site Reference ID/Investigator# 28193         
Site Reference ID/Investigator# 28196 Recruiting
Giessen, Germany, 35390
Principal Investigator: Site Reference ID/Investigator# 28196         
Site Reference ID/Investigator# 28261 Recruiting
Halle, Germany, 06108
Principal Investigator: Site Reference ID/Investigator# 28261         
Site Reference ID/Investigator# 47157 Withdrawn
Hamburg, Germany, 20095
Site Reference ID/Investigator# 28236 Withdrawn
Hamburg, Germany, 20357
Site Reference ID/Investigator# 28202 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 28202         
Site Reference ID/Investigator# 47154 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 47154         
Site Reference ID/Investigator# 28256 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 28256         
Site Reference ID/Investigator# 28259 Recruiting
Hamburg, Germany, 20246
Principal Investigator: Site Reference ID/Investigator# 28259         
Site Reference ID/Investigator# 28248 Recruiting
Hannover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 28248         
Site Reference ID/Investigator# 28230 Recruiting
Hanover, Germany, 30159
Principal Investigator: Site Reference ID/Investigator# 28230         
Site Reference ID/Investigator# 28238 Withdrawn
Karlsruhe, Germany, 76135
Site Reference ID/Investigator# 47153 Recruiting
Koblenz, Germany, 56065
Principal Investigator: Site Reference ID/Investigator# 47153         
Site Reference ID/Investigator# 18221 Recruiting
Krefeld, Germany, 47800
Principal Investigator: Site Reference ID/Investigator# 18221         
Site Reference ID/Investigator# 47151 Recruiting
Ludwigshafen, Germany, 67063
Principal Investigator: Site Reference ID/Investigator# 47151         
Site Reference ID/Investigator# 28192 Recruiting
Luebeck, Germany, 23538
Principal Investigator: Site Reference ID/Investigator# 28192         
Site Reference ID/Investigator# 54278 Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Site Reference ID/Investigator# 54278         
Site Reference ID/Investigator# 28247 Withdrawn
Mainz, Germany, 55116
Site Reference ID/Investigator# 28190 Recruiting
Muenster, Germany, 48143
Principal Investigator: Site Reference ID/Investigator# 28190         
Site Reference ID/Investigator# 47152 Withdrawn
Muenster, Germany, 48149
Site Reference ID/Investigator# 47150 Withdrawn
Muenster, Germany, 48143
Site Reference ID/Investigator# 28197 Recruiting
Muenster, Germany, 48149
Principal Investigator: Site Reference ID/Investigator# 28197         
Site Reference ID/Investigator# 28226 Withdrawn
Munich, Germany, 80337
Site Reference ID/Investigator# 28203 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28203         
Site Reference ID/Investigator# 28200 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28200         
Site Reference ID/Investigator# 28235 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28235         
Site Reference ID/Investigator# 114675 Recruiting
Munich, Germany, 81675
Principal Investigator: Site Reference ID/Investigator# 114675         
Site Reference ID/Investigator# 28225 Recruiting
Munich, Germany, 80335
Principal Investigator: Site Reference ID/Investigator# 28225         
Site Reference ID/Investigator# 28242 Recruiting
Munich, Germany, 80331
Principal Investigator: Site Reference ID/Investigator# 28242         
Site Reference ID/Investigator# 81614 Recruiting
Nuremberg, Germany, 90461
Principal Investigator: Site Reference ID/Investigator# 81614         
Site Reference ID/Investigator# 28241 Withdrawn
Oldenburg, Germany, 26121
Site Reference ID/Investigator# 28240 Recruiting
Osnabrueck, Germany, 49076
Principal Investigator: Site Reference ID/Investigator# 28240         
Site Reference ID/Investigator# 47149 Recruiting
Regensburg, Germany, 93053
Principal Investigator: Site Reference ID/Investigator# 47149         
Site Reference ID/Investigator# 63683 Withdrawn
Rostock, Germany, 18057
Site Reference ID/Investigator# 28201 Withdrawn
Saarbruecken, Germany, 66111
Site Reference ID/Investigator# 63686 Recruiting
Schkeuditz, Germany, 04435
Principal Investigator: Site Reference ID/Investigator# 63686         
Site Reference ID/Investigator# 28257 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 28257         
Site Reference ID/Investigator# 28239 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 28239         
Site Reference ID/Investigator# 28204 Withdrawn
Tuebingen, Germany, 72072
Site Reference ID/Investigator# 28234 Recruiting
Wuppertal, Germany, 42277
Principal Investigator: Site Reference ID/Investigator# 28234         
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
Anti-Retroviral Agents
Lopinavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 15, 2014