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Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection (LATHCV)

This study has been terminated.
(small number of patients enrolled)
Sponsor:
Collaborator:
Fundación de Investigación de Diego
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01182298
First received: August 13, 2010
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: April 23, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Hepatitis C
HIV

  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
No text entered.

Reporting Groups
  Description
PegIFN and Ribavirin

Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.

This is an observational study. The observed treatment is received and managed through their primary care.


Participant Flow:   Overall Study
    PegIFN and Ribavirin  
STARTED     10  
COMPLETED     4  
NOT COMPLETED     6  
Lack of Efficacy                 4  
Withdrawal by Subject                 2  



  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.
LATINO PARTICIPANTS WITH hepatitis C

Reporting Groups
  Description
Standard HCV INFECTED LATINO ARTICIPANTS

Baseline Measures
    Standard  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     7  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     10  
Not Hispanic or Latino     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     0  
Puerto Rico     10  



  Outcome Measures

1.  Primary:   Median Log Change in HCV RNA Levels on Day 7   [ Time Frame: first 7 days ]


  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
Early termination due to small numbers of subjects enrolled as the options for HCV treatment changed significantly since the start of the study planning.


  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: Shyam Kottilil
Organization: NIAID
e-mail: Skottilil@niaid.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01182298     History of Changes
Other Study ID Numbers: 100159, 10-I-0159
Study First Received: August 13, 2010
Results First Received: April 23, 2014
Last Updated: September 26, 2014
Health Authority: United States: Federal Government