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Trial record 62 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02339038
Recruitment Status : Completed
First Posted : January 15, 2015
Results First Posted : July 12, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care
Hide Arm/Group Description Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Period Title: Overall Study
Started 600
Completed 0
Not Completed 600
Arm/Group Title Standard of Care
Hide Arm/Group Description Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Overall Number of Baseline Participants 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
<=18 years
0
   0.0%
Between 18 and 65 years
522
  87.0%
>=65 years
78
  13.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
Female
184
  30.7%
Male
416
  69.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 participants
Hispanic or Latino
11
   1.8%
Not Hispanic or Latino
589
  98.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 600 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%
1.Primary Outcome
Title Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
Hide Description The primary outcome was the number 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 the limit of quantification (<15IU/mL).
Time Frame At least 12 weeks after completion of medication
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included all patients who received at least one dose of ledipasvir-sofosbuvir
Arm/Group Title Standard of Care
Hide Arm/Group Description:
Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
Overall Number of Participants Analyzed 600
Measure Type: Count of Participants
Unit of Measure: Participants
516
  86.0%
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care
Hide Arm/Group Description Standard of care treatment using ledipasvir 90mg-sofosbuvir 400mg by mouth daily for 2, 3, or 6 months
All-Cause Mortality
Standard of Care
Affected / at Risk (%)
Total   8/600 (1.33%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care
Affected / at Risk (%)
Total   0/600 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care
Affected / at Risk (%)
Total   76/600 (12.67%) 
General disorders   
Fatigue   45/600 (7.50%) 
Nervous system disorders   
Headache   40/600 (6.67%) 
Indicates events were collected by systematic assessment
Although primary outcome is complete, the study remains active for prolonged observation and numerous secondary outcomes, with a projected closure date in 2025.
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: NCT02339038     History of Changes
Other Study ID Numbers: 15N064
15-CC-N064 ( Other Identifier: NIH )
999915064 ( Other Identifier: NIHCC )
First Submitted: January 14, 2015
First Posted: January 15, 2015
Results First Submitted: June 15, 2017
Results First Posted: July 12, 2017
Last Update Posted: August 14, 2018