Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

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


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

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

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 )
Study First Received:	April 17, 2012
Last Updated:	October 5, 2016

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

ClinicalTrials.gov processed this record on August 18, 2017