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Clinical Trials

MainTitle

HCV-HIV Co-infected Patient Cohort in Thailand

This study is ongoing, but not recruiting participants.
Sponsor
Institut de Recherche pour le Developpement

Collaborator
Ministry of Health, Thailand

Information provided by (Responsible Party)
Gonzague Jourdain, Institut de Recherche pour le Developpement

ClinicalTrials.gov Identifier
NCT02247440

First received: September 9, 2014
Last updated: August 29, 2016
Last Verified: August 2016
History of Changes
Purpose

Purpose

This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment.

Chronic hepatitis C virus (HCV) infection is responsible for several severe and life threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV replication is suppressed on antiretroviral treatment.

The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured are no longer contagious to other individuals, therefore widespread access to HCV treatment may contribute to the control of the HCV epidemic.

A combination of injectable pegylated-interferon with oral ribavirin is currently the recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They are administered for 24 weeks in HCV mono-infected patients but need to be administered for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter treatment.

PRIMARY OBJECTIVE

1. To determine the percentage of patients according to genotypes with sustained virological response 6 months after treatment discontinuation (SVR).

HCV TREATMENT

  • Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week)
  • Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of
anemia.

A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a first part (starting in August 2014) and 45 patients in a second part, depending on funding.

Condition Intervention Phase
Hepatitis C Infection
HIV

Drug : Peg-interferon + ribavirin under HIV physician supervision
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand

Further study details as provided by Gonzague Jourdain, Institut de Recherche pour le Developpement:

Primary Outcome Measures

  • Sustained virological response 6 months after treatment discontinuation [ Time Frame: 6 months after end of treatment, i.e. 1.5 years after treatment initiation ]
    Percentage of patients according to genotypes with sustained undetectable HCV RNA after discontinuation of HCV treatment
Secondary Outcome Measures:
  • Safety of treatment [ Time Frame: On treatment through 6 months after discontinuation ]
    Incidence of serious adverse events associated with study treatment (peg-interferon and ribavirin)
  • Impact of HCV treatment on HIV [ Time Frame: At time of treatment discontinuation (whatever its date) and 6 months thereafter ]
    Cellular HIV DNA concentrations in patients receiving HCV treatment
Other Outcome Measures:
  • Operational issues [ Time Frame: 2.5 years after the initiation of the study ]
    This is a composite criterion: Proportion of patients screened and enrolled in the study who have completed the first 24 and 48 weeks of treatment Incidence of adverse events by severity grade Compliance with study visit schedule Adherence to HCV and HIV treatment (peg-interferon injections, number of missed doses of oral treatment during the last week, pill count) Number/percentage of patients able to perform self-injections.

Biospecimen Retention: Samples With DNA
blood

Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
PegINF-ribavirin
Peg-interferon + ribavirin under HIV physician supervision Peg-interferon alpha 2-b initial dosing is 1.5 micrograms/kg (subcutaneous injection) once a week Ribavirin initial dosing in the morning and in the evening: For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily). For genotypes 1, 4, 5 and 6: 800 mg/day, if bodyweight <65 kg, 1000 mg/day, if bodyweight between 66-80 kg, 1200 mg/day, if bodyweight between 81-105 kg, 1400 mg/day, if bodyweight >105 kg. Duration: 48 weeks
Drug: Peg-interferon + ribavirin under HIV physician supervision

Peg-interferon + ribavirin under HIV physician supervision

Other Name: Pegintron, Rebetol

Detailed Description:

Study Population Screening: HIV infected patients with a positive anti-HCV test will be approached for screening if they are at least 18 years old, participate in the PHPT cohort study, have evidence of control of HIV replication and have a CD4 cell count ≥200 cells/mm3 if currently receiving antiretroviral HIV treatment (on the same anti-HIV regimen for at least 12 weeks); or HIV RNA load ≤5000 copies/ml CD4 cells ≥500 cells/mm3if not receiving antiretroviral treatment.
Inclusion Criteria

  • Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
  • Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
  • Negative pregnancy test (on the day of inclusion). Main exclusion criteria
  • Anemia and thrombocytopenia
  • Severe liver damage, advanced stage cirrhosis or cancer
  • Uncontrolled diabetes, Uncontrolled thyroid dysfunction
  • Retinopathy
  • Creatinine clearance <50 mL/min (Cockcroft)
  • Disease associated with the immune system
  • Significant heart problems
  • Severe neuropsychiatric conditions
  • Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
  • Other exclusion criteria related to the use of ribavirin and peg-interferon
  • Any conditions that, in the investigator's judgment, may compromise the follow up.
Follow up After HCV treatment initiation, patients will be monitored for safety and antiviral efficacy at 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 weeks (end of treatment) and 6 months after treatment discontinuation.
Treatment will be discontinued earlier in patients who do not achieve early viral response, i.e. a decrease of at least 2 log10 HCV RNA IU/mL after the first 12 weeks of HCV therapy.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV-HCV co-infected adults

Criteria

Inclusion Criteria:

  • Evidence of chronic HCV infection for at least 6 months before study entry (at least one detectable HCV viral load, i.e. ≥17 IU/mL, with an antibody test positive at least 6 months before the HCV RNA load result)
  • Fibrosis Stage F2-3-4 determined by transient elastography (Fibroscan or other similar equipment). During the first part of the study, priority will be given to patients with Fibrosis Stage F2-3.
  • Negative pregnancy test (on the day of inclusion).


Exclusion Criteria:
  • Anemia and thrombocytopenia
  • Severe liver damage, advanced stage cirrhosis or cancer
  • Uncontrolled diabetes, Uncontrolled thyroid dysfunction
  • Retinopathy
  • Creatinine clearance <50 mL/min (Cockcroft)
  • Disease associated with the immune system
  • Significant heart problems
  • Severe neuropsychiatric conditions Contra-indication to study treatment (including pregnancy or lack of effective contraception in the participant or female partner)
  • Other exclusion criteria related to the use of ribavirin and peg-interferon
  • Any conditions that, in the investigator's judgment, may compromise the follow up.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247440

Locations

Thailand
Sanpatong Hospital
Sanpatong, Chiang Mai, Thailand, 50120
Nakornping Hospital
Chiang Mai, Thailand, 50180
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 57000
Chonburi Hospital
Chonburi, Thailand, 20000
Samutsakhon Hospital
Samutsakorn, Thailand, 74000

Sponsors and Collaborators

Institut de Recherche pour le Developpement
Ministry of Health, Thailand

Investigators

Principal Investigator: Gonzague Jourdain, MD, PhD Institut de Recherche pour le Developpement
More Information

More Information


Responsible Party: Gonzague Jourdain, Researcher, Institut de Recherche pour le Developpement  
ClinicalTrials.gov Identifier: NCT02247440   History of Changes  
Other Study ID Numbers: PHPT-HCV  
Study First Received: September 9, 2014  
Last Updated: August 29, 2016  

Keywords provided by Gonzague Jourdain, Institut de Recherche pour le Developpement:

HCV
HIV
Thailand
pegylated interferon
ribavirin

Additional relevant MeSH terms:
Infection
Hepatitis C
Interferons
Ribavirin

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.