Clinical trial NCT02344680: Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
Official title: Liver Fibrosis in Zambian HIV-HBV Co-infected Patients: a Long-term Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Human Immunodeficiency Virus
HBV
Fibrosis, Liver
Cirrhosis, Liver
Hepatocellular Carcinoma
Hepatitis Delta Virus
Alcoholic Hepatitis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: National Institutes of Health (NIH)
First posted: 2015-01-26
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 adults with HIV-HBV coinfection

Brief summary: A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel HBV cure drugs.

Detailed description: Among people with HIV in Africa, liver disease is a neglected area of investigation but is anticipated to become increasingly common as patients live longer due to antiretroviral therapy. In Lusaka, Zambia, we previously (NCT02060162, clinicaltrials.gov) described that HIV-HBV co-infection was the most important liver risk factor. However, in that study, only very short-term outcomes could be assessed. Building on these preliminary results and addressing the need to study HIV-HBV during a longer duration of follow-up, the current protocol will focus exclusively on people with HIV-HBV in Zambia. Zambia is an ideal site for this research as it has \~12% HIV prevalence and 6% HBsAg-positivity among adults nationwide. In fact, \~70% of people with HIV-HBV globally reside in Africa. In the proposed study, we will obtain consent from people with HIV-HBV to participate in an observational cohort study with up to 10 years of follow-up. Standard of care antiviral therapies will be received by participants. More in-depth analysis of liver and HBV viral and serological outcomes will occur. Screening for liver cancer will also occur. This study will provide useful clinical and epidemiological information to health policymakers in Zambia and beyond. It will also provide a platform for the training of health workers in Zambia in HBV clinical management.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Living with HIV infection
* Living with active HBV infection, defined as any single positive HBsAg assay
* Naïve to antiretroviral therapy or currently participating in HIV/HBV co-infection in IeDEA-SA

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Planning to relocate out of Lusaka district

Primary outcomes:
measure: Change in liver fibrosis stage
timeFrame: From baseline to 10 years of follow-up
Secondary outcomes:
measure: Incidence of hepatocellular carcinoma
timeFrame: From baseline to 10 years of follow-up
measure: Prevalence of significant liver fibrosis (Metavir F2 or greater)
timeFrame: At enrollment
measure: Prevalence of persistent HBV viremia: Measure HBV DNA at month 24
timeFrame: Month 24
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia (CIDRZ)
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael J Vinikoor, MD
role: PRINCIPAL_INVESTIGATOR
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