HBV-HIV Coinfection Research Network
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01924455|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2013
Last Update Posted : June 5, 2018
|Condition or disease|
|Hepatitis B Human Immunodeficiency Virus|
|Study Type :||Observational|
|Actual Enrollment :||139 participants|
|Official Title:||HBV-HIV Coinfection Research Network|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
HBV-HIV coinfected subjects
HBV-HIV coinfected subjects seen at one of 7 participating centers.
- 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
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
|United States, California|
|University of California|
|San Francisco, California, United States|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States|
|Bethesda, Maryland, United States|
|United States, Massachusetts|
|Mass General Hospital|
|Boston, Massachusetts, United States|
|United States, Missouri|
|Saint Louis, Missouri, United States|
|United States, Texas|
|Dallas, Texas, United States|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States|
|Toronto, Ontario, Canada|
|Principal Investigator:||Richard Sterling, MD, MSc||Virginia Commonwealth University|