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HCV-HIV Co-infected Patient Cohort in Thailand

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ClinicalTrials.gov Identifier: NCT02247440
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement

Brief Summary:

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 or disease Intervention/treatment Phase
Hepatitis C Infection HIV Drug: Peg-interferon + ribavirin under HIV physician supervision Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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:

  1. For genotypes 2, 3: ribavirin 400 mg (i.e. 800 mg daily).
  2. 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




Primary Outcome Measures :
  1. Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation [ Time Frame: 6 months after end of treatment, i.e. 1.5 years after treatment initiation ]
    Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,


Secondary Outcome Measures :
  1. Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin) [ Time Frame: From initiation of treatment to 6 months after treatment discontinuation ]
    Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).

  2. Number of Participants Grouped by HIV-1 RNA Concentrations [ Time Frame: At time of treatment discontinuation (whatever its date) and 6 months thereafter ]
    Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).


Other Outcome Measures:
  1. Number of Participants Completed the First 24 and 48 Weeks of Treatment [ Time Frame: From initiation of treatment to the first 48 weeks of treatment ]
    Number of participants completed the first 24 and 48 weeks of treatment.

  2. Number of Adverse Events by Severity Grade [ Time Frame: From initiation of treatment to 6 months after treatment discontinuation ]
    Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.

  3. Number of Participants Able to Perform Self-injections of Peg-interferon [ Time Frame: From initiation of treatment to the first 48 weeks of treatment ]
    Number of participants able to perform self-injections of peg-interferon.

  4. Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80% [ Time Frame: From initiation of treatment to the first 48 weeks of treatment ]
    Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and < 80%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247440


Locations
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Thailand
Sanpatong Hospital
San Pa Tong, Chiang Mai, Thailand, 50120
Nakornping Hospital
Chiang Mai, Thailand, 50180
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 57000
Chonburi Hospital
Chon Buri, Thailand, 20000
Samutsakhon Hospital
Samut Sakhon, Thailand, 74000
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Ministry of Health, Thailand
Investigators
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Principal Investigator: Gonzague Jourdain, MD, PhD Institut de Recherche pour le Developpement
  Study Documents (Full-Text)

Documents provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:

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Responsible Party: GONZAGUE JOURDAIN, Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT02247440     History of Changes
Other Study ID Numbers: PHPT-HCV
First Posted: September 25, 2014    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Keywords provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:
HCV
HIV
Thailand
pegylated interferon
ribavirin
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action