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

April 17, 2012
April 19, 2013
May 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01581853 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 reconcilitation 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)
Not Provided
Not Provided
 
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
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
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
Intervention: Drug: Lopinavir/ritonavir 800 mg / 200mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Daniel Podzamczer, MD dpodzamczer@bellvitgehospital.cat
Contact: Juan Manuel Tiraboschi, MD jmtiraboschi@bellvitgehospital.cat
Spain
 
NCT01581853
KMON, 2011-005981-39
No
Daniel Podzamczer, Hospital Universitari de Bellvitge
Daniel Podzamczer
Not Provided
Principal Investigator: Daniel Podzamczer, MD Hospital Universitari de Bellvitge
Principal Investigator: Hernando Knobel, MD Hospital del Mar
Hospital Universitari de Bellvitge
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP