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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 13, 2014