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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581853
• Other study ID #: KMON
• Secondary ID: 2011-005981-39
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2012
• Last updated: October 5, 2016
• Start date: May 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2013
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Bercelona	Barcelona
Spain	Hospital Universitary de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Podzamczer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma viral load <40 copies/mL	HIV Plasma Viral Load <40 copies/ml at week 48.	Week 48	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Satisfaction	Patients' satisfaction with the new regimen will be evaluated using a questionnaire (SMAQ)	Weeks 4, 8, 12, 16, 24, 36 and 48	No
Secondary	- 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	Yes