Status:
TERMINATED
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
FDI Clinical Research
Conditions:
Hepatitis C
HIV
Eligibility:
All Genders
18-99 years
Brief Summary
* Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously ...
Detailed Description
Hepatitis C is a major health problem affecting 100- 300 million individuals worldwide. Chronic hepatitis C virus (HCV) infection leads to cirrhosis in approximately 20% of subjects over a period of 1...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A subject must satisfy all of the following criteria to be eligible to participate in this study:
- Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded.
- Age greater than or equal to 18 years.
- Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL.
- Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive.
- Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or CD4+ cell percentage greater than or equal to 14%.
- Ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies.
- Participants must have a primary care physician managing medical problems.
- For HIV infected participants, care provided by a primary physician must be consistent with the current DHHS guidelines. For those on therapy, HAART will be provided by their physician.
- Willing to undergo genetic testing
- About to start HCV treatment (with or without direct acting agents DAAs)
- EXCLUSION CRITERIA:
- A subject will be ineligible to participate in this study if any of the following criteria are met:
- Unable to comply with research study visits
- Have any condition that the investigator considers a contraindication to study participation.
- Pregnant or breastfeeding women.
- Patients with poor venous access
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01182298
Start Date
July 1 2010
End Date
March 1 2013
Last Update
September 24 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892