NCT00437476

Brief Summary

The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV. Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Feb 2007

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

3.4 years

First QC Date

February 20, 2007

Last Update Submit

February 5, 2009

Conditions

HIV InfectionsHepatitis C

Keywords

HIV/HCVHIV and HCV coinfected patientsTreatment Naive

Outcome Measures

Primary Outcomes (4)

  • To assess if the combination of LPV/r monotherapy in association with

    18 months

  • anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional

    18 months

  • toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin

    18 months

  • in patients naïve for HIV and HCV

    18 months

Secondary Outcomes (3)

  • To assess if LPV/r monotherapy during the HCV treatment

    18 and 24 months

  • is associated with anti HIV efficacy and a better patient satisfaction

    18 and 24 months

  • vs optimized HAART.

    18 and 24 months

Study Arms (2)

A

EXPERIMENTAL

LPV/r + selected NRTIs for 26 weeks, followed by LPV/r monotherapy and anti HCV drugs for 48 weeks. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.

Drug: LPV/rDrug: Nucleoside Reverse Transcriptase InhibitorsDrug: PEG-IFNa 2aDrug: Ribavirin

B

ACTIVE COMPARATOR

LPV/r+ selected NRTIs for 24 weeks, followed by the same HAART and anti-HCV drugs for 48 weeks. At the end of the co-treatment for HCV/HIV, each subject will be treated for HIV infection according to physician decision. All the patients will be followed-up for 24 weeks after the end of anti-HCV drugs for the evaluation of SVR.As anti-HCV drugs the patients will receive PEG-IFNa 2a 180 mcg/week + Ribavirin 1-1.2 g/day . At the end of week 12 of combined therapy, only patients who will reach an early virological response will continue anti-HCV drugs.

Drug: LPV/rDrug: Nucleoside Reverse Transcriptase InhibitorsDrug: PEG-IFNa 2aDrug: Ribavirin

Interventions

LPV/rDRUG

Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)

AB
Nucleoside Reverse Transcriptase InhibitorsDRUG

NRTIs for 26 weeks (A) or 24 weeks (B)

AB
PEG-IFNa 2aDRUG

PEG-IFNa 2a 180 mcg/week (48 weeks)

AB
RibavirinDRUG

Ribavirin 1-1.2 g/day (48 weeks)

AB

Eligibility Criteria

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

You may qualify if:

  • Subject is \>18 years old
  • Subject has given written informed consent
  • Serologic evidence of HIV infection by HIV antibody and HIV-RNA detection
  • Serologic evidence of HCV infection by HCV antibody and HCV-RNA detection
  • Subject is naive for HIV and HCV therapy
  • Subject has active chronic hepatitis or compensated cirrhosis (Child-Pugh class A)
  • Subject has a CD4+ count \> 200 cell/mm3 and \<500 cell/mm3.
  • Subject has genotype available at baseline and no mutations (IAS)associated with resistance to antiretroviral drugs used.
  • Subject and partner will use effective contraceptive methods for the duration of the study

You may not qualify if:

  • Subject is HbsAg positive
  • Subject has cirrhosis score Child-Pugh B/C, no previous hepatic decompensation
  • Subject has HIV-related thrombocytopenia (Platelets count \< 50.000 mmc)
  • Subject has neutrophils count \< 1500/mmc
  • Subject has Hb value \< 9 g/dL at screening and \<11 g/dL at randomization
  • Subject has creatinine value \> 1.5 mg/dL
  • Subject is on a HAART regimen included ddI and/or AZT
  • Subject is pregnant or wishes to become so
  • Subject has any cause of liver disease other than chronic hepatitis C, status of liver decompensation or any other condition consistent with decompensated liver disease (bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy)
  • Subject is alcohol abuser (\> 30 gr/die)
  • Prior treatment with PEG-IFN/ribavirin
  • Illicit drugs abuse that in the opinion of the investigator could lead to poor compliance with the terms of the protocol (maintenance treatment with methadone allowed)
  • Active heart disease (e.g. angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia)
  • Subject has pre-existing severe depression, condition of severe psychiatric disorders such as suicidal ideation, suicide attempts, depression or acute psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital Dep. Infectious Diseases

Milan, 20127, Italy

RECRUITING

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

Ribavirin

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)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Adriano Lazzarin, MD

    IRCCS San Raffaele Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriano Lazzarin, MD

CONTACT

+39/02/26437939adriano.lazzarin@hsr.it

Caterina Uberti-Foppa, MD

CONTACT

+39/02/26437938caterina.uberti@hsr.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

IT(1)