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

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Lopinavir/ritonavir 800 mg / 200mg

• Registration Number: NCT01581853
• Lead Sponsor: Daniel Podzamczer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-05
• Status Verified: 2013-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lopinavir/ritonavir 800 mg / 200mg	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

Primary Outcome Measures

Name	Time	Method
plasma viral load <40 copies/mL	Week 48	HIV Plasma Viral Load \<40 copies/ml at week 48.

Secondary Outcome Measures

Name	Time	Method
Stability in the plasma levels of Lopinavir/ritonavir during all study visits	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	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	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	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	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)

Trial Locations

Locations (2)

Hospital Universitary de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital del Mar; 🇪🇸 Bercelona, Barcelona, Spain