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Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

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ClinicalTrials.gov Identifier: NCT01443923
Recruitment Status : Terminated (Unable to complete enrollment due to newly approved treatment options.)
First Posted : September 30, 2011
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis
HIV/AIDS
Interventions Drug: Boceprevir
Drug: Peg-Interferon-alfa 2B
Drug: Ribavirin
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Period Title: Overall Study
Started 3 1
Completed 2 1
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title 1-HCV 2 HCV/HIV Total
Hide Arm/Group Description

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 1 participants 4 participants
58  (3) 56  (0) 57.5  (2.64575)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
1
  33.3%
0
   0.0%
1
  25.0%
Male
2
  66.7%
1
 100.0%
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 4 participants
3 1 4
1.Primary Outcome
Title Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.
Hide Description [Not Specified]
Time Frame 6 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description:

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects
Hide Description [Not Specified]
Time Frame Day 0, Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description:

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Safety and Treatment Outcome Measures Stratified by ESA Use
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description:

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment
Hide Description [Not Specified]
Time Frame End of Treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description:

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects
Hide Description [Not Specified]
Time Frame 6 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description:

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1-HCV 2 HCV/HIV
Hide Arm/Group Description

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

All-Cause Mortality
1-HCV 2 HCV/HIV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1-HCV 2 HCV/HIV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/1 (0.00%)    
Gastrointestinal disorders     
Abdomina Pain  1/3 (33.33%)  1 0/1 (0.00%)  0
Vomiting  1/3 (33.33%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders     
Hypoalbuminaemia  1/3 (33.33%)  1 0/1 (0.00%)  0
Nervous system disorders     
Convulsion 1 [1]  1/3 (33.33%)  1 0/1 (0.00%)  0
Renal and urinary disorders     
Renal Failure Acute 1 [2]  1/3 (33.33%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA
[1]
Seizure: (New Onset)
[2]
Acute Kidney Injury
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1-HCV 2 HCV/HIV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/1 (100.00%)    
Cardiac disorders     
Supraventricular Tachycardia  1/3 (33.33%)  1 0/1 (0.00%)  0
Eye disorders     
Diplopia  0/3 (0.00%)  0 1/1 (100.00%)  1
Eye Pain  0/3 (0.00%)  0 1/1 (100.00%)  1
Gastrointestinal disorders     
Nausea  1/3 (33.33%)  1 0/1 (0.00%)  0
Vomiting  1/3 (33.33%)  1 0/1 (0.00%)  0
General disorders     
Fatigue  2/3 (66.67%)  2 0/1 (0.00%)  0
Injection Site Reaction  1/3 (33.33%)  1 0/1 (0.00%)  0
Infections and infestations     
Cellulitis  1/3 (33.33%)  1 0/1 (0.00%)  0
Nasopharyngitis 1 [1]  1/3 (33.33%)  1 0/1 (0.00%)  0
Pneumonia  1/3 (33.33%)  1 0/1 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1/3 (33.33%)  1 0/1 (0.00%)  0
Haemoglobin decreased  1/3 (33.33%)  4 0/1 (0.00%)  0
Neutrophil count decreased  2/3 (66.67%)  8 1/1 (100.00%)  2
Metabolism and nutrition disorders     
Hypoalbuminaemia  0/3 (0.00%)  0 1/1 (100.00%)  1
Hypoglycaemia  1/3 (33.33%)  1 1/1 (100.00%)  1
Hypomagnesaemia  1/3 (33.33%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1/3 (33.33%)  1 0/1 (0.00%)  0
Nervous system disorders     
Convulsion 1 [2]  1/3 (33.33%)  1 0/1 (0.00%)  0
Headache  1/3 (33.33%)  2 0/1 (0.00%)  0
Renal and urinary disorders     
Renal Failure Acute  1/3 (33.33%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA
[1]
CommonCold
[2]
Seizures
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Shyam Kottilil
Organization: NIAID/NIH
Phone: 301-435-0936
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01443923     History of Changes
Other Study ID Numbers: 110253
11-I-0253
First Submitted: September 29, 2011
First Posted: September 30, 2011
Results First Submitted: February 25, 2015
Results First Posted: July 13, 2015
Last Update Posted: July 13, 2015