HBV-HIV Coinfection Research Network
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ClinicalTrials.gov Identifier: NCT01924455 |
Recruitment Status
:
Recruiting
First Posted
: August 16, 2013
Last Update Posted
: August 8, 2017
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Condition or disease |
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Hepatitis B Human Immunodeficiency Virus |
Study Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | HBV-HIV Coinfection Research Network |
Study Start Date : | April 2014 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Group/Cohort |
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HBV-HIV coinfected subjects
HBV-HIV coinfected subjects seen at one of 7 participating centers.
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- Liver disease severity [ Time Frame: 4 years ]We will clinically, histologically, serologically, and virologically characterize a well-defined cohort of HBV-HIV patients in North America in a cross-sectional manner
- Outcome of viral suppression [ Time Frame: 4 years ]
- We will longitudinally determine the impact of complete vs. incomplete viral suppression on clinical and serologic outcomes, and histologic progression by paired biopsy.
- Define a threshold HBV DNA level associated with disease progression.
- Establish the utility of noninvasive assessment of hepatic fibrosis compared with biopsy.
- Define the frequency of genotypic and phenotypic TDF resistance with long term therapy
- We will assess the long term renal and bone effects of TDF-based therapy in the HBV-HIV cohort.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: (1) Male and female subjects ≥ 18 years of age; (2) Serologic evidence of HIV infection by HIV antibody positivity or positive HIV-RNA > 6 months prior to screening (3) Serologic evidence of chronic hepatitis B infection by HBsAg positivity(4) Willingness to provide informed consent.
Exclusion Criteria: (1) Estimated life expectancy of less than one year based on clinical judgment of the investigator; (2) Hepatic decompensation as defined by presence of ascites or hepatic hydrothorax, variceal or portal hypertensive bleeding, hepatic encephalopathy, or Child-Turcotte-Pugh (CTP) score of 7 or above; (3) Hepatocellular carcinoma (HCC); (4) Anti-HCV positive; (5) History of solid organ or bone marrow transplantation; (6) Pregnant women; (7) Medical or social condition which in the opinion of the study physician would make the patient unsuitable for the study or will interfere with or prevent follow-up per protocol; (8) Unable or unwilling to return for follow-up visits; (9) Contraindications to liver biopsy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924455
Contact: Richard Sterling, MD, MSc | richard.sterling@vcuhealth.org |
United States, California | |
University of California | Recruiting |
San Francisco, California, United States | |
Principal Investigator: Mandana Khalili, MD | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States | |
Principal Investigator: Mark Sulkowski, MD | |
NIDDK | Recruiting |
Bethesda, Maryland, United States | |
Contact: Marc Ghany, MD | |
Principal Investigator: Marc Ghany, MD | |
United States, Massachusetts | |
Mass General Hospital | Recruiting |
Boston, Massachusetts, United States | |
Principal Investigator: Raymond Chung, MD | |
United States, Missouri | |
Washington University | Recruiting |
Saint Louis, Missouri, United States | |
Principal Investigator: Mauricio Lisker-Melman, MD | |
United States, Texas | |
UT Southwestern | Recruiting |
Dallas, Texas, United States | |
Principal Investigator: Mamta Jain, MD | |
United States, Virginia | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States | |
Principal Investigator: Richard Sterling, MD, MSc | |
Canada, Ontario | |
Toronto Hospital | Recruiting |
Toronto, Ontario, Canada | |
Principal Investigator: David Wong, MD |
Principal Investigator: | Richard Sterling, MD, MSc | Virginia Commonwealth University |
Additional Information:
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT01924455 History of Changes |
Other Study ID Numbers: |
HM20000444 DK094818 ( Other Identifier: NIH ) |
First Posted: | August 16, 2013 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
Keywords provided by Virginia Commonwealth University:
HIV HBV |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis B Immunologic Deficiency Syndromes Coinfection Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Hepatitis Liver Diseases |
Digestive System Diseases Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Infection Parasitic Diseases |