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Trial record 83 of 396 for:    IFNA2 AND RBV AND sustained

HCV-HIV Co-infected Patient Cohort in Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C Infection
HIV
Intervention Drug: Peg-interferon + ribavirin under HIV physician supervision
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Period Title: Overall Study
Started 18
Completed 14
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Lack of Efficacy             3
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants
44.2
(39.6 to 51.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female 6
Male 12
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 18 participants
18
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 18 participants
18
Body Mass Index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants
21.8
(20.6 to 25.7)
HCV RNA  
Median (Inter-Quartile Range)
Unit of measure:  Log10 IU/mL
Number Analyzed 18 participants
5.83
(5.59 to 6.75)
HCV genotypes   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Gt 1a
2
  11.1%
Gt 1b
8
  44.4%
Gt 3a
5
  27.8%
Gt 3b
1
   5.6%
Gt 6a/b
1
   5.6%
Gt 6c-l
1
   5.6%
[1]
Measure Description: Response to and duration of peg-interferon treatment vary according to Hepatitis C virus (HCV) genotypes. Prior to initiating HCV treatment, HCV genotype was determined using the INNO-LiPA technique.
IL 28B polymorphism   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
CC
14
  77.8%
CT
4
  22.2%
[1]
Measure Description: Single nucleotide polymorphisms (SNP) on IL-28B in particular at position called rs12979860, are associated with different responses to peg-interferon+ribavirin treatment. For example the rs12979860 CC is predictive of good response to treatment. This SNP was assessed in all participants at baseline using SNP real-time PCR assay.
Liver fibrosis stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
F2
1
   5.6%
F3
4
  22.2%
F4
13
  72.2%
[1]
Measure Description:

Assessment of Liver fibrosis stages is needed to decide the HCV treatment.

Liver Fibrosis stage was assessed by transient elastography ultrasound based technique that measured the stiffness of the liver. There are five stages starting from F0 no scarring until F4: cirrhosis or advanced scarring and treatment in this study was initiated in participants with F2-F4 fibrosis stages. Response to treatment was expected to be better in participants with lower fibrosis stages.

1.Primary Outcome
Title Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
10
  55.6%
2.Secondary Outcome
Title Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
3.Secondary Outcome
Title Number of Participants Grouped by HIV-1 RNA Concentrations
Hide Description Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).
Time Frame At time of treatment discontinuation (whatever its date) and 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
HIV-1 RNA not detected
16
  88.9%
HIV-1 RNA detected
1
   5.6%
Missing
1
   5.6%
4.Other Pre-specified Outcome
Title Number of Participants Completed the First 24 and 48 Weeks of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Completed the first 24 weeks of treatment
14
  77.8%
Completed the first 48 weeks of treatment
14
  77.8%
5.Other Pre-specified Outcome
Title Number of Adverse Events by Severity Grade
Hide Description 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.
Time Frame From initiation of treatment to 6 months after treatment discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: events
AE grade 1 18
AE grade 2 7
AE grade 3 1
6.Other Pre-specified Outcome
Title Number of Participants Able to Perform Self-injections of Peg-interferon
Hide Description Number of participants able to perform self-injections of peg-interferon.
Time Frame From initiation of treatment to the first 48 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
  1. subject discontinued treatment after week 1
  2. subjects discontinued treatment after week 12

1 subject discontinued treatment after week 24

Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 to Week 12 Number Analyzed 17 participants
PegINF injected
17
 100.0%
PegINF not injected
0
   0.0%
Week 12 to Week 16 Number Analyzed 17 participants
PegINF injected
16
  94.1%
PegINF not injected
1
   5.9%
Week 16 to Week 28 Number Analyzed 15 participants
PegINF injected
15
 100.0%
PegINF not injected
0
   0.0%
Week 28 to Week 32 Number Analyzed 14 participants
PegINF injected
13
  92.9%
PegINF not injected
1
   7.1%
Week 32 to Week 48 Number Analyzed 14 participants
PegINF injected
14
 100.0%
PegINF not injected
0
   0.0%
7.Other Pre-specified Outcome
Title Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
  1. subject discontinued treatment after week 1
  2. subjects discontinued treatment after week 12

1 subject discontinued treatment after week 24

Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description:

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 to Week 2 Number Analyzed 17 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
2
  11.8%
Compliance ≥ 95%
15
  88.2%
Week 2 to Week 4 Number Analyzed 17 participants
Compliance < 80%
1
   5.9%
Compliance 80% - 95%
1
   5.9%
Compliance ≥ 95%
15
  88.2%
Week 4 to Week 12 Number Analyzed 17 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
17
 100.0%
Week 12 to Week 16 Number Analyzed 17 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
1
   5.9%
Compliance ≥ 95%
16
  94.1%
Week 16 to Week 20 Number Analyzed 15 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
15
 100.0%
Week 20 to Week 24 Number Analyzed 15 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
2
  13.3%
Compliance ≥ 95%
13
  86.7%
Week 24 to Week 28 Number Analyzed 15 participants
Compliance < 80%
1
   6.7%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
14
  93.3%
Week 28 to Week 32 Number Analyzed 14 participants
Compliance < 80%
1
   7.1%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
13
  92.9%
Week 32 to Week 36 Number Analyzed 14 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
14
 100.0%
Week 36 to Week 44 Number Analyzed 14 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
1
   7.1%
Compliance ≥ 95%
13
  92.9%
Week 44 to Week 48 Number Analyzed 14 participants
Compliance < 80%
0
   0.0%
Compliance 80% - 95%
0
   0.0%
Compliance ≥ 95%
14
 100.0%
Time Frame From enrollment until 6 months after treatment discontinuation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PegINF-ribavirin
Hide Arm/Group Description

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

Peg-interferon + ribavirin under HIV physician supervision: Peg-interferon + ribavirin under HIV physician supervision

All-Cause Mortality
PegINF-ribavirin
Affected / at Risk (%)
Total   0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PegINF-ribavirin
Affected / at Risk (%) # Events
Total   2/18 (11.11%)    
Blood and lymphatic system disorders   
Neutropenia *  1/18 (5.56%)  1
Gastrointestinal disorders   
Gastritis *  1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegINF-ribavirin
Affected / at Risk (%) # Events
Total   13/18 (72.22%)    
Blood and lymphatic system disorders   
Anemia *  8/18 (44.44%)  9
Neutropenia *  10/18 (55.56%)  30
Thrombocytopenia *  8/18 (44.44%)  14
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gonzague Jourdain
Organization: Institut de Recherche pour le Developpement
Phone: +66818830065
EMail: Gonzague.Jourdain@ird.fr
Layout table for additonal information
Responsible Party: GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT02247440     History of Changes
Other Study ID Numbers: PHPT-HCV
First Submitted: September 9, 2014
First Posted: September 25, 2014
Results First Submitted: March 16, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019