Kaletra in Combination With Antiretroviral Agents - Full Text View

Purpose

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

Condition	Intervention
Human Immunodeficiency Virus	Drug: lopinavir/ritonavir Drug: Raltegravir Drug: Maraviroc Drug: Rilpivirine Drug: Etravirine

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir Etravirine Maraviroc Rilpivirine Raltegravir Raltegravir potassium

U.S. FDA Resources

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:	550
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2016
Estimated Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Drug: lopinavir/ritonavir 3 capsules 2 x daily or 2 tablets 2 x daily (Protease inhibitor) Other Names: ABT-378/r Kaletra Drug: Raltegravir 2 tablets 400 mg 2 x daily (Integrase inhibitor) Other Name: Isentress Drug: Maraviroc 2 tablets 150 mg 2 x daily (C-C chemokine receptor type 5) Other Name: Celsentri Drug: Rilpivirine 1 tablet 25 mg 1 x daily (Non-nucleoside reverse transcriptase inhibitor) Other Name: Edurant Drug: Etravirine 2 tablets 200 mg 2 x daily (Non-nucleoside reverse transcriptase inhibitor) Other Name: Intelence

Groups/Cohorts

Assigned Interventions

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

Drug: lopinavir/ritonavir

3 capsules 2 x daily or 2 tablets 2 x daily (Protease inhibitor)

Other Names:

ABT-378/r
Kaletra

Drug: Raltegravir

2 tablets 400 mg 2 x daily (Integrase inhibitor)

Other Name: Isentress

Drug: Maraviroc

2 tablets 150 mg 2 x daily (C-C chemokine receptor type 5)

Other Name: Celsentri

Drug: Rilpivirine

1 tablet 25 mg 1 x daily (Non-nucleoside reverse transcriptase inhibitor)

Other Name: Edurant

Drug: Etravirine

2 tablets 200 mg 2 x daily (Non-nucleoside reverse transcriptase inhibitor)

Other Name: Intelence

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

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 55 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Stefan Simianer, MD

AbbVie Deutschland GmbH & Co. KG, Medical Department

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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:	March 8, 2013
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
Ritonavir

Lopinavir
Anti-Retroviral Agents
Integrase Inhibitors
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 May 16, 2013

Kaletra in Combination With Antiretroviral Agents (PROTEKT)