NCT01581853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 6, 2016

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

April 17, 2012

Last Update Submit

October 5, 2016

Conditions

HIV

Keywords

HIVAIDSMONOTHERAPYPILOTLOPINAVIR/RITONAVIR

Outcome Measures

Primary Outcomes (1)

  • plasma viral load <40 copies/mL

    HIV Plasma Viral Load \<40 copies/ml at week 48.

    Week 48

Secondary Outcomes (5)

  • Stability in the plasma levels of Lopinavir/ritonavir during all study visits

    Weeks 4, 8, 12, 16, 24, 36 and 48

  • Tolerability

    Weeks 4, 8, 12, 16, 24, 36 and 48

  • Adherence

    Weeks 4, 8, 12, 16, 24, 36 and 48

  • Satisfaction

    Weeks 4, 8, 12, 16, 24, 36 and 48

  • - Efficacy in CSF

    At least 4 weeks on study treatment

Study Arms (1)

Lopinavir/ritonavir 800 mg / 200mg

OTHER

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

Interventions

Lopinavir/ritonavir 800 mg / 200mgDRUG

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

Also known as: Kaletra 200/50 mg comprimidos recubiertos con película
Lopinavir/ritonavir 800 mg / 200mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital del Mar

Bercelona, Barcelona, 08003, Spain

Location

Hospital Universitary de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

LopinavirRitonavirlopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Daniel Podzamczer, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

  • Hernando Knobel, MD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD. HIV/AIDS Program Director. HIV Unit. Infectious Disease Service

Study Record Dates

First Submitted

April 17, 2012

First Posted

April 20, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 6, 2016

Record last verified: 2013-04

Locations

ES(2)