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

NCT01182298 | Terminated Results

• 2 other identifiers: 10015910-I-0159
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV.
• Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection. Objectives: \- To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. This is an observational study. The observed treatment is received and managed through their primary care.

Conditions

Hepatitis C; HIV

Keywords

Latino; HCV; pegIFN; Viral Kinetics; IL-28 Haplotype

Outcome Measures

Primary Outcomes (1)

• Median Log Change in HCV RNA Levels on Day 7

  The primary end point of this study is the the log change in HCV RNA levels on Day 7

  first 7 days

Study Arms (1)

Hepatitis C

latino participants with Hepatitis C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

latino with or without HIV infection undergoing Hepatitis C treatment

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• FDI Clinical Research: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Seeff LB, Hoofnagle JH. Appendix: The National Institutes of Health Consensus Development Conference Management of Hepatitis C 2002. Clin Liver Dis. 2003 Feb;7(1):261-87. doi: 10.1016/s1089-3261(02)00078-8.

  PMID: 12691470 BACKGROUND

• Engels EA, Chatterjee N, Cerhan JR, Davis S, Cozen W, Severson RK, Whitby D, Colt JS, Hartge P. Hepatitis C virus infection and non-Hodgkin lymphoma: results of the NCI-SEER multi-center case-control study. Int J Cancer. 2004 Aug 10;111(1):76-80. doi: 10.1002/ijc.20021.

  PMID: 15185346 BACKGROUND

• Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.

  PMID: 9121257 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum storage.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Shyam Kottilil
• Organization: NIAID

Skottilil@niaid.nih.gov

Study Officials

• Shyamasundaran Kottilil, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 16, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 24, 2019
• Results First Posted: October 2, 2014

Record last verified: 2014-09

Locations

US (1)