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Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV

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ClinicalTrials.gov Identifier: NCT02124044
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : April 13, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-HCV
Interventions Drug: Asunaprevir and Daclatasvir
Drug: Asunaprevir and Daclatasvir with BMS-791325
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Hide Arm/Group Description Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
Period Title: Overall Study
Started 20 10
Completed 20 9
Not Completed 0 1
Arm/Group Title HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV Total
Hide Arm/Group Description Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients Total of all reporting groups
Overall Number of Baseline Participants 20 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  95.0%
9
  90.0%
28
  93.3%
>=65 years
1
   5.0%
1
  10.0%
2
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Female
8
  40.0%
7
  70.0%
15
  50.0%
Male
12
  60.0%
3
  30.0%
15
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Hispanic or Latino
3
  15.0%
0
   0.0%
3
  10.0%
Not Hispanic or Latino
15
  75.0%
8
  80.0%
23
  76.7%
Unknown or Not Reported
2
  10.0%
2
  20.0%
4
  13.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  60.0%
9
  90.0%
21
  70.0%
White
5
  25.0%
0
   0.0%
5
  16.7%
More than one race
1
   5.0%
0
   0.0%
1
   3.3%
Unknown or Not Reported
2
  10.0%
1
  10.0%
3
  10.0%
1.Primary Outcome
Title The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
Hide Description The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Time Frame 12 weeks after stop of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received treatment drugs per arm as listed in the Outcome Measure Description
Arm/Group Title HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Hide Arm/Group Description:
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
Overall Number of Participants Analyzed 20 10
Measure Type: Number
Unit of Measure: Percentage of subjects
90 80
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Hide Arm/Group Description Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
All-Cause Mortality
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   5/10 (50.00%) 
Cardiac disorders     
Acute myocardial infarction   1/20 (5.00%)  0/10 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis   1/20 (5.00%)  0/10 (0.00%) 
Infections and infestations     
Influenza   0/20 (0.00%)  1/10 (10.00%) 
Pneumonia   0/20 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Meningioma   0/20 (0.00%)  1/10 (10.00%) 
Nervous system disorders     
Cerebrovascular accident   1/20 (5.00%)  1/10 (10.00%) 
Psychiatric disorders     
Paranoia   1/20 (5.00%)  0/10 (0.00%) 
Depression   0/20 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325 HIV/HCV GT-1b, 24 Wks ASV/DCV
Affected / at Risk (%) Affected / at Risk (%)
Total   6/20 (30.00%)   3/10 (30.00%) 
General disorders     
Fatigue   1/20 (5.00%)  0/10 (0.00%) 
Pain   1/20 (5.00%)  0/10 (0.00%) 
Infections and infestations     
Bronchitis   0/20 (0.00%)  1/10 (10.00%) 
Investigations     
Lipase increased   0/20 (0.00%)  1/10 (10.00%) 
Platelet count decreased   0/20 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Hypophosphataemia   3/20 (15.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity   1/20 (5.00%)  0/10 (0.00%) 
Psychiatric disorders     
Insomnia   1/20 (5.00%)  0/10 (0.00%) 
Panic disorder   1/20 (5.00%)  0/10 (0.00%) 
Psychotic disorder   1/20 (5.00%)  0/10 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis   1/20 (5.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment

One subject did not complete 24 weeks of study drug due to a HCV viral load rebound on treatment (at week 6) and was deemed a non-responder. This met the criteria for stopping study medications.

Nine subjects completed 24 weeks of therapy.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Masur, Henry
Organization: NIH Clinical Center
Phone: +1 301 496 9320
EMail: HMasur@cc.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02124044    
Other Study ID Numbers: 140065
14-CC-0065 ( Other Identifier: National Institutes of Health )
First Submitted: April 25, 2014
First Posted: April 28, 2014
Results First Submitted: March 1, 2017
Results First Posted: April 13, 2017
Last Update Posted: May 16, 2017