NCT00866021

Brief Summary

The aim of this study is to assess the efficacy of lopinavir/r in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
1 country

10 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

Study Start

First participant enrolled

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2013

Enrollment Period

4.3 years

First QC Date

March 18, 2009

Last Update Submit

March 14, 2025

Conditions

HIV/HCV Co-infectionHIV Infections

Keywords

HIV infectionHCV infectiontreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Assess efficacy of concomitant treatment with lopinavir/r monotherapy and PEG-INF plus RBV for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV

    80 weeks

Secondary Outcomes (4)

  • Tolerability and safety of concomitant treatment with LPV/r, PEG-INF and RBV

    80 weeks

  • CD4

    80 weeks

  • Efficacy

    80 weeks

  • Adherence

    80 weeks

Study Arms (2)

1

EXPERIMENTAL

Lopinavir/ritonavir (LPV/r) as single antiretroviral administered concomitantly with peg-interferon and ribavirin

Drug: Lopinavir/ritonavir

2

ACTIVE COMPARATOR

Lopinavir/ritonavir (LPV/r) with 2 NRTIs, administered concomitantly with peg-interferon and ribavirin

Drug: Lopinavir/ritonavir with two nucleoside analogs

Interventions

Lopinavir/ritonavirDRUG

NRTI sparing-regimen

Also known as: Kaletra
1
Lopinavir/ritonavir with two nucleoside analogsDRUG

LPV/r plus 2NRTIs + PEG-INF + RBV

2

Eligibility Criteria

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

You may qualify if:

  • Subject consent to participate in this study after being informed of all trial aspects that may influence his/her decision, given by signing and dating the informed consent form approved by the CREC of the corresponding center.
  • Subject is at least 18 years old, is co-infected by HIV and HCV, and has been recommended treatment for HCV infection.
  • Liver biopsy confirming the presence of chronic hepatitis performed within one year of patient entry into the study.
  • CD4 at screening should be at least or greater to 350 cells/microl
  • Subject on continued, uninterrupted antiretroviral therapy for the past 6 months with
  • LPV/r + 2 NRTIs/NtRTIs for at least 4 weeks;
  • NNRTI + 2 NRTIs
  • NRTIs Only changes in protease inhibitor due solely to toxicity, simplification, or optimization are acceptable
  • Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
  • Subject has a Karnofsky index \>-70.
  • Throughout the study, the patient does not require and agrees not to take any of the following drugs, that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication due to the possibility of a significant decrease in Kaletra concentrations during concomitant administration.
  • Subject agrees not to take any medication, including over-the-counter medicines, alcohol, drugs, or herbal preparations without the knowledge and approval of the principal investigator.
  • Laboratory tests have been made in the subject in the past 30 days.
  • Hemoglobin \>8.0 g/dL Absolute neutrophil count \>750 cells/microL Platelet count \>20.000/microL ALT or AST \<5 x upper normal limit (UNL) Creatinine \<1.5 x UNL
  • Triglycerides \<750 mg/dL.
  • +2 more criteria

You may not qualify if:

  • Subjects will be excluded from study participation if they meet any of the following criteria:
  • Subjects in whom a switch in protease inhibitor has ever been made due to suspected or documented virological failure.
  • Subjects requiring treatment with drugs whose association with LPV/r is contraindicated based on Kaletra prescribing information..
  • Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.
  • Pregnancy or nursing, and in women of childbearing age, if they do not agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.
  • In the opinion of the principal investigator, patient is unlikely to comply with the study protocol, or the patient was not eligible for any other reason.
  • Subjects infected by the hepatitis B virus and who are being treated with tenofovir (TDF) or lamivudine (3TC).
  • Prior treatment with interferon (pegylated or not) and/or ribavirin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08910, Spain

Location

Hospital General de Castellón

Castellon, Castellón, 12004, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Location

Hospital General Sta. Mª del Rosell

Cartagena, Murcia, 30203, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital la Paz

Madrid, 28046, Spain

Location

Hospital La Princesa

Madrid, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

Lopinavirlopinavir-ritonavir drug combinationRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Enrique Ortega

    Hospital General Universitario de Valencia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 20, 2009

Study Start

February 1, 2008

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

March 17, 2025

Record last verified: 2013-03

Locations

ES(10)