Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia

NCT02628691 | Terminated

• 1 other identifier: HCV-Monitoring
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients. Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2. The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment. All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate. Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.

Conditions

Hepatitis C; HIV

Outcome Measures

Primary Outcomes (1)

• Short-term progression to advanced liver fibrosis

  Proportion of patients who progress to advanced liver fibrosis (F≥3; LSM ≥9.5 kPa).

  30 months

Secondary Outcomes (9)

• Demographic characteristics

  Baseline

• Clinical characteristics

  Baseline

• Laboratory characteristics

  Baseline

• Progression to cirrhosis

  30 months

• Liver stiffness measurement

  30 months

Study Arms (1)

HCV coinfection with no-to-moderate fibrosis

Other: Liver fibrosis progression

Interventions

Liver fibrosis progression OTHER

A history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed. Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.

HCV coinfection with no-to-moderate fibrosis

Eligibility Criteria

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

Study Population

Adult HIV-infected patients of the SHCH cohort who have chronic HCV infection (all genotypes) with no-to-moderate hepatic fibrosis and not considered in immediate need of HCV treatment.

You may qualify if:

• Male and females
• ≥18 years
• Documented HIV infection
• Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA
• Absence of advanced liver disease or clinical signs of extra-hepatic disease:
• F0-F2 (\< 9,5 kPa) established by transient elastography, and
• No clinical signs of extra-hepatic disease
• Not on HCV antiviral treatment

You may not qualify if:

• Currently on/or history of hepatitis C treatment
• Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography)
• Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Sihanouk Hospital Center of HOPE: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (1)

Sihanouk Hospital Center of HOPE (SHCH), Cambodia

Phnom Penh, Cambodia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Left over biological samples (whole blood plasma and serum)

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

Study Officials

• Anja De Weggheleire, MD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY DIRECTOR

• An Sokkab, MD

  Sihanouk Hospital Center of HOPE (SHCH), Cambodia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 11, 2015
• Study Start: December 17, 2015
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

CA (1)