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NCT Number: NCT02247440

HCV-HIV Co-infected Patient Cohort in Thailand

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.

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HIV Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanpatong Hospital, San Pa Tong, Chiang Mai, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peg-interferon + ribavirin under HIV physician supervision

Drug

Peg-interferon + ribavirin under HIV physician supervision

Other names: Pegintron, Rebetol

Primary outcomes

  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 outcomes

  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 outcomes

  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%.

Sponsors and collaborators

Lead sponsor

Institut de Recherche pour le Developpement

Other Gov

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 25, 2014
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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