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Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581853
First Posted: April 20, 2012
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Podzamczer, Hospital Universitari de Bellvitge
  Purpose
Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.

Condition Intervention Phase
HIV Drug: Lopinavir/ritonavir 800 mg / 200mg Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

Resource links provided by NLM:


Further study details as provided by Daniel Podzamczer, Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • plasma viral load <40 copies/mL [ Time Frame: Week 48 ]
    HIV Plasma Viral Load <40 copies/ml at week 48.


Secondary Outcome Measures:
  • Stability in the plasma levels of Lopinavir/ritonavir during all study visits [ Time Frame: Weeks 4, 8, 12, 16, 24, 36 and 48 ]
    Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48

  • Tolerability [ Time Frame: Weeks 4, 8, 12, 16, 24, 36 and 48 ]
    Possible Adverse Events will be collected in all study visits and laboratory tests will also be performed in all study visits (weeks 4, 8, 12, 16, 24, 36 and 48)

  • Adherence [ Time Frame: Weeks 4, 8, 12, 16, 24, 36 and 48 ]
    Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients

  • Satisfaction [ Time Frame: Weeks 4, 8, 12, 16, 24, 36 and 48 ]
    Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)

  • - Efficacy in CSF [ Time Frame: At least 4 weeks on study treatment ]
    - In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)


Enrollment: 21
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lopinavir/ritonavir 800 mg / 200mg
Kaletra 200/50 mg comprimidos recubiertos con película Lopinavir/ritonavir 800 mg / 200mg will be changed from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
Drug: Lopinavir/ritonavir 800 mg / 200mg
Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
Other Name: Kaletra 200/50 mg comprimidos recubiertos con película

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18, HIV positive
  • Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
  • Undetectable viral load (<40 copies/ml) during the last 6 months
  • Patients that accept participation in the study and sign the Informed Consent Form
  • Childbearing females with negative pregnancy tests and using appropriate contraceptive measures

Exclusion Criteria:

  • Opportunistic disease, cancer or any other active disease with specific treatment
  • Active addiction to illegal drugs or active use of psychotropic drugs
  • Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved > 3 months)
  • Females who are breastfeeding or pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581853


Locations
Spain
Hospital del Mar
Bercelona, Barcelona, Spain, 08003
Hospital Universitary de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Daniel Podzamczer
Investigators
Principal Investigator: Daniel Podzamczer, MD Hospital Universitari de Bellvitge
Principal Investigator: Hernando Knobel, MD Hospital del Mar
  More Information

Responsible Party: Daniel Podzamczer, MD. HIV/AIDS Program Director. HIV Unit. Infectious Disease Service, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01581853     History of Changes
Other Study ID Numbers: KMON
2011-005981-39 ( EudraCT Number )
First Submitted: April 17, 2012
First Posted: April 20, 2012
Last Update Posted: October 6, 2016
Last Verified: April 2013

Keywords provided by Daniel Podzamczer, Hospital Universitari de Bellvitge:
HIV
AIDS
MONOTHERAPY
PILOT
LOPINAVIR/RITONAVIR

Additional relevant MeSH terms:
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors


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