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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01471574




Registration number
NCT01471574
Ethics application status
Date submitted
4/11/2011
Date registered
15/11/2011
Date last updated
29/01/2016

Titles & IDs
Public title
Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
Scientific title
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)
Secondary ID [1] 0 0
2011-003067-30
Secondary ID [2] 0 0
AI444-043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Genotype 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Ribavirin
Treatment: Drugs - PEG-Interferon alfa 2a

Experimental: Daclatsvir + Ribavirin + PEG-Interferon alfa-2a -


Treatment: Drugs: Daclatasvir
Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks

Treatment: Drugs: Ribavirin
Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response

Treatment: Drugs: PEG-Interferon alfa 2a
Syringe, subcutaneous injection, 180 µg, once weekly, 24 or 48 weeks depending on response
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Timepoint [1] 0 0
Follow-up Week 12
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
Timepoint [1] 0 0
Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Timepoint [2] 0 0
Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Secondary outcome [3] 0 0
Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA =400 Copies/mL
Timepoint [3] 0 0
End of treatment (up to Week 48)
Secondary outcome [4] 0 0
Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Timepoint [4] 0 0
Follow-up Week 12
Secondary outcome [5] 0 0
Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
Timepoint [5] 0 0
From Day 1 to 7 days post last dose of study treatment (up to Week 48)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Key

- Males and females, 18 to 70 years of age

- Hepatitis C virus (HCV) genotype 1a or 1b

- HCV-treatment naive

- HCV RNA >10,000 IU/mL at screening

- HIV-1 infection (approximately 250 patients receiving highly active antiretroviral
therapy [HAART], up to 50 patients not receiving HAART)

- For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and
must be <400 copies/ml for at least 6 months prior to screening

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients receiving HAART who first initiated antiretroviral therapy within the last 6
months of Day 1

- Patients receiving HAART who have changed their antiretroviral regimen due to safety
or efficacy associated to HIV treatment within the last 3 months prior to Day 1.
However, if changes are required to a patient's HAART regimen to meet the requirements
of the protocol, these changes are allowed at the screening visit. The patient should
wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been
confirmed, <40 copies/ mL

- Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment
period of the trial (patients receiving HAART who have changed their antiretroviral
regimen to initiate any HCV treatment within 6 weeks prior to Day 1)

- Laboratory values:

1. Neutrophil count <1500 cells/µL (<1200 cells/ µL for Blacks)

2. Platelet count <90,000 cells/µL

3. Hemoglobin =12 g/dL for females, hemoglobin =13 g/dL for males

4. Total bilirubin =34 µmol/L (or =2 mg/dL) unless a patient has a documented
history of Gilbert's disease or antiretroviral regimen contains atazanavir

5. Alanine aminotransferase =5*upper limit of normal

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
549
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst Nsw
Recruitment hospital [2] 0 0
Local Institution - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - Clayton
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst Nsw
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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Florida
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Maryland
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Santa Fe
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Argentina
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Cordoba
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Belgium
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Antwerpen
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Belgium
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Brussels
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
State/province [24] 0 0
Marseille Cedex 09
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France
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Montpellier Cedex 5
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France
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Paris Cedex 10
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France
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Paris
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France
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Pessac Cedex
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Frankfurt Am Main
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Germany
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Frankfurt
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Germany
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Hamburg
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Italy
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Brescia
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Italy
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Milano
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Italy
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Modena
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Italy
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Torino
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Puerto Rico
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San Juan
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Russian Federation
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Kaluga
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Russian Federation
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Lipetsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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St.petersburg
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Russian Federation
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Volgograd
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Spain
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Barcelona
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Spain
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Cordoba
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Madrid
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Spain
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Sevilla
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United Kingdom
State/province [51] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir
plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients
coinfected with HIV
Trial website
https://clinicaltrials.gov/ct2/show/NCT01471574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01471574