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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Lopinavir/ritonavir 800 mg / 200mg

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Bercelona, Barcelona, Spain, 08003
      • Hospital del Mar
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitary de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Kaletra 200/50 mg comprimidos recubiertos con película

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma viral load <40 copies/mL	HIV Plasma Viral Load <40 copies/ml at week 48.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability in the plasma levels of Lopinavir/ritonavir during all study visits	Determination of plasma concentrations of the study drug at weeks 4, 8, 12, 16, 24, 36 and 48	Weeks 4, 8, 12, 16, 24, 36 and 48
Tolerability	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)	Weeks 4, 8, 12, 16, 24, 36 and 48
Adherence	Medication adherence will be evaluated in all the study visits after making a reconciliation of the medication dispensed and returned by the patients	Weeks 4, 8, 12, 16, 24, 36 and 48
Satisfaction	Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)	Weeks 4, 8, 12, 16, 24, 36 and 48
- Efficacy in CSF	- In a subsample of patients (10) HIV-1 RNA in CSF will be assessed (added as per amendment)	At least 4 weeks on study treatment

Collaborators and Investigators

• Sponsor: Daniel Podzamczer
• Investigators: Principal Investigator: Daniel Podzamczer, MD, Hospital Universitari de Bellvitge; Principal Investigator: Hernando Knobel, MD, Hospital del Mar

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HIV; AIDS; MONOTHERAPY; PILOT; LOPINAVIR/RITONAVIR
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: KMON; 2011-005981-39 (EudraCT Number)