A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02032888
First received: January 9, 2014
Last updated: September 24, 2015
Last verified: August 2015
Results First Received: August 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Daclatasvir
Drug: Sofosbuvir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 37 sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 238 participants were enrolled, and 203 received treatment. Of the 35 participants who were enrolled but did not receive treatment, 2 withdrew consent, 31 no longer met study criteria, 1 was lost to follow-up, and 1 was eliminated for other reasons.

Reporting Groups
  Description
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks     Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks     Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks  
STARTED     101     50     52  
COMPLETED     99     48     52  
NOT COMPLETED     2     2     0  
Poor compliance/noncompliance                 1                 1                 0  
Not specified                 1                 1                 0  

Period 2:   Follow-up Period
    Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks     Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks     Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks  
STARTED     100 [1]   49 [1]   52  
COMPLETED     97     47     52  
NOT COMPLETED     3     2     0  
Lost to Follow-up                 1                 1                 0  
Death                 1                 1                 0  
Not specified                 1                 0                 0  
[1] All patients who received study drug and not a nonstudy HCV therapy before treatment Week 4



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 dose of active study therapy.

Reporting Groups
  Description
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Total Total of all reporting groups

Baseline Measures
    Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks     Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks     Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks     Total  
Number of Participants  
[units: participants]
  101     50     52     203  
Age  
[units: years]
Mean (Standard Deviation)
  50.1  (9.77)     50.8  (9.19)     55.7  (6.21)     51.7  (9.12)  
Age, Customized  
[units: participants]
       
<65 years     96     47     49     192  
>=65 years     5     3     3     11  
Gender  
[units: participants]
       
Female     9     8     9     26  
Male     92     42     43     177  
Hepatitis C Virus RNA  
[units: log10┬áIU/mL]
Mean (Standard Deviation)
  6.50  (0.758)     6.40  (0.71)     6.52  (0.789)     6.48  (0.753)  
Hepatitis C Virus RNA distribution  
[units: participants]
       
<800,000 IU/mL     22     6     8     36  
≥800,000 IU/mL     79     44     44     167  



  Outcome Measures
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1.  Primary:   Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)   [ Time Frame: At follow-up Week 12 ]

2.  Secondary:   Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)   [ Time Frame: At follow-up Week 12 ]

3.  Secondary:   Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)   [ Time Frame: At follow-up Week 12 ]

4.  Secondary:   Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)   [ Time Frame: At follow-up Week 12 ]

5.  Secondary:   Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24   [ Time Frame: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24 ]

6.  Secondary:   Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)   [ Time Frame: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment ]

7.  Secondary:   Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)   [ Time Frame: At Follow-up Week 12 ]

8.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period   [ Time Frame: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks) ]

9.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period   [ Time Frame: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period. ]

10.  Secondary:   Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results   [ Time Frame: From screening up to week 24 of post treatment follow­-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888     History of Changes
Other Study ID Numbers: AI444-216
Study First Received: January 9, 2014
Results First Received: August 21, 2015
Last Updated: September 24, 2015
Health Authority: United States: Food and Drug Administration