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

This study is currently recruiting participants.
Verified April 2013 by Hospital Universitari de Bellvitge
Sponsor:
Information provided by (Responsible Party):
Daniel Podzamczer, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01581853
First received: April 17, 2012
Last updated: April 19, 2013
Last verified: April 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • plasma viral load <40 copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    - In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581853

Contacts
Contact: Daniel Podzamczer, MD dpodzamczer@bellvitgehospital.cat
Contact: Juan Manuel Tiraboschi, MD jmtiraboschi@bellvitgehospital.cat

Locations
Spain
Hospital del Mar Recruiting
Bercelona, Barcelona, Spain, 08003
Principal Investigator: Hernando Knobel, MD         
Hospital Universitary de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Daniel Podzamczer, MD    0034933359011 ext 2885    dpodzamczer@bellvitgehospital.cat   
Contact: Juan Manuel Tiraboschi, MD    0035933359011    jmtiraboschi@bellvitgehospital.cat   
Principal Investigator: Daniel Podzamczer, MD         
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

No publications provided

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
Study First Received: April 17, 2012
Last Updated: April 19, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014