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Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01878799
First received: June 14, 2013
Last updated: July 27, 2016
Last verified: July 2016
Results First Received: March 31, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
HIV
Intervention: Drug: GS-7977/GS- 5885 FDC

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Subjects With HIV and HCV on Antiretroviral Agents Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.

Participant Flow:   Overall Study
    Subjects With HIV and HCV on Antiretroviral Agents     Subjects With HIV and HCV Who Are Not on Antiretroviral Agents  
STARTED     37     13  
COMPLETED     36     13  
NOT COMPLETED     1     0  



  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.
No text entered.

Reporting Groups
  Description
Subjects With HIV and HCV on Antiretroviral Agents Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Subjects With HIV and HCV Who Are Not on Antiretroviral Agents Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Total Total of all reporting groups

Baseline Measures
    Subjects With HIV and HCV on Antiretroviral Agents     Subjects With HIV and HCV Who Are Not on Antiretroviral Agents     Total  
Number of Participants  
[units: participants]
  37     13     50  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     32     13     45  
>=65 years     5     0     5  
Gender  
[units: Participants]
     
Female     7     6     13  
Male     30     7     37  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     2     0     2  
Not Hispanic or Latino     35     13     48  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     31     10     41  
White     6     3     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)   [ Time Frame: 12 weeks after completion of treatment ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shyam Kottilil
Organization: National Institute of Allergy and Infectious Diseases
phone: +1 301 435 0936
e-mail: skottilil@niaid.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01878799     History of Changes
Other Study ID Numbers: 130159
13-I-0159
Study First Received: June 14, 2013
Results First Received: March 31, 2016
Last Updated: July 27, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration