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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01878799
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C
HIV
Intervention: Drug: GS-7977/GS- 5885 FDC

  Participant Flow

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
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 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

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 
Overall Participants Analyzed 
[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

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
No text entered.


  More Information

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
First Submitted: June 14, 2013
First Posted: June 17, 2013
Results First Submitted: March 31, 2016
Results First Posted: September 15, 2016
Last Update Posted: September 15, 2016