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Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia

This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
First Posted: January 15, 2015
Last Update Posted: July 12, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
Results First Submitted: June 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HCV HIV
Intervention: Drug: Ledipasvir 90 mg and Sofosbuvir 400 mg

  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
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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
Standard of Care Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months

Participant Flow:   Overall Study
    Standard of Care
STARTED   600 

  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
Standard of Care Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months

Baseline Measures
   Standard of Care 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      522  87.0% 
>=65 years      78  13.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      184  30.7% 
Male      416  69.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      11   1.8% 
Not Hispanic or Latino      589  98.2% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      2   0.3% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      578  96.3% 
White      20   3.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  Outcome Measures

1.  Primary:   Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs   [ Time Frame: At least 12 weeks after completion of medication ]

  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
Although primary outcome is complete, the study remains active for prolonged observation and numerous secondary outcomes, with a projected closure date in 2025.

  More Information
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