HCV-HIV Co-infected Patient Cohort in Thailand

NCT02247440 | Completed Phase 4 Results

• 1 other identifier: PHPT-HCV
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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.

Conditions

Hepatitis C Infection; HIV

Keywords

HCV; HIV; Thailand; pegylated interferon; ribavirin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation

  Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,

  6 months after end of treatment, i.e. 1.5 years after treatment initiation

Secondary Outcomes (2)

• Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)

  From initiation of treatment to 6 months after treatment discontinuation

• Number of Participants Grouped by HIV-1 RNA Concentrations

  At time of treatment discontinuation (whatever its date) and 6 months thereafter

Other Outcomes (4)

• Number of Participants Completed the First 24 and 48 Weeks of Treatment

  From initiation of treatment to the first 48 weeks of treatment

• Number of Adverse Events by Severity Grade

  From initiation of treatment to 6 months after treatment discontinuation

• Number of Participants Able to Perform Self-injections of Peg-interferon

  From initiation of treatment to the first 48 weeks of treatment

Study Arms (1)

PegINF-ribavirin

EXPERIMENTAL

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

Interventions

Peg-interferon + ribavirin under HIV physician supervision DRUG

Peg-interferon + ribavirin under HIV physician supervision

Also known as: Pegintron, Rebetol

PegINF-ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Any conditions that, in the investigator's judgment, may compromise the follow up.

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Ministry of Health, Thailand: collaborator

Study Sites (5)

Sanpatong Hospital

San Pa Tong, Chiang Mai, 50120, Thailand

Location

Nakornping Hospital

Chiang Mai, 50180, Thailand

Location

Chiangrai Prachanukroh Hospital

Chiang Rai, 57000, Thailand

Location

Chonburi Hospital

Chon Buri, 20000, Thailand

Location

Samutsakhon Hospital

Samut Sakhon, 74000, Thailand

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Gonzague Jourdain
• Organization: Institut de Recherche pour le Developpement

Gonzague.Jourdain@ird.fr

+66818830065

Study Officials

• Gonzague Jourdain, MD, PhD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 25, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

TH (5)