Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients

NCT02093754 | Completed

• 2 other identifiers: ECHAM2012-A01670-43
• Study Type: interventional
• Target: 460
• Locations: 3 countries
• Sites: 7

Brief Summary

This study will allow to assess liver related injuries in HIV patients.

Conditions

HIV Infection; Liver Injuries

Outcome Measures

Primary Outcomes (1)

• Percentage of steatosis detected by MRI

  Within 6 months after all patients have completed MRI

Secondary Outcomes (8)

• Percentage of fibrosis or cirrhosis using non invasive markers and concordance of non invasive markers

  Within 6 months after all patients have completed the study

• Risk factors (age, duration of infection, treatment, clinical and biological metabolic and adipose tissue parameters) of liver injuries

  Within 6 months after all patients have completed the study

• Independent risk factors of NAFLD, NASH and fibrosis (including markers of insulin resistance, inflammatory cytokines, markers of immune activation, adipokines)

  Within 6 months after all patients have completed the study

• Establish a diagnosis score based on biomarkers of liver injuries (Adiponectin, leptin, IL6, CRP, CD14)

  Within 6 months after all patients have completed the study

• Description of pathogenetic factors and correlates with autophagy in liver biopsies of patients with evidence for liver fibrosis

  Within 6 months after all patients have completed the study

Interventions

MRI and biopsy PROCEDURE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years
• Infection with HIV-1
• Cumulative exposure to cART for at least 5 years and currently under cART
• Viral load \< 400 copies/mL
• CD4 count \> 100 CD4/mm3
• Female may be eligible to enter and participate in the study if she:
• is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
• is of child-bearing potential with a negative blood pregnancy test at screening visit
• Informed consent signed prior to any study procedure
• To be covered by a medical insurance (only for French centres)
• Presence of:
• the metabolic syndrome as defined by the most recent international consensus definition (Alberti et al. Circulation 2009) including three components among the following criteria:
• visceral obesity (waist circumference: Europeans and Africans ≥ 94 cm for men and ≥ 80 cm for women, Americans ≥ 102 cm for men and ≥ 88 cm for women, Asians ≥ 90 cm for men and ≥ 80 cm for women)
• blood glucose ≥ 1 g/L (5,6 mmol/L) or anti-diabetic treatment,
• serum triglycerides ≥ 1,5 g/L (1,7 mmol/L) or hypertriglycerides treatment,

You may not qualify if:

• Coinfection with hepatitis B (positive HBs antigen or isolated positive HBc antibody with positive PCR)
• Positive HCV serology
• Coinfection HIV-1 and HIV-2
• Use of intravenous drugs within the last six months
• Excessive alcohol intake (male \> 50 g/d, female \> 40 g/d)
• Other causes of liver diseases i.e: viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary or secondary biliary cirrhosis, primary or secondary cholangitis, α1 antitrypsine deficiency
• Other causes of liver steatosis: current steroid therapy, current therapy with amiodarone, tamoxifen, methotrexate, nifedipine, or hycanthone; history of cancer chemotherapy; short bowel syndrome, polycystic ovarian syndrome, Weber-Christian disease
• Active opportunistic infection except for candida oesophagitis
• Current Cancer
• Pregnancy
• Decompensated heart failure
• Subject under legal guardianship
• Inability to give informed consent or incapacitation
• Contra-indication to MRI: pace-maker, neurovascular surgery, intraocular materials, cochlear implant, severe claustrophobia

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (7)

CHU Brussels

Brussels, Belgium

Location

Hôpital la Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Medical Center for Infectious Diseases

Berlin, Germany

Location

Center for HIV and Hepato-Gastroenterology

Düsseldorf, Germany

Location

University Medical Center

Hamburg, Germany

Location

Hannover Medical School

Hanover, Germany

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Magnetic Resonance Spectroscopy; Biopsy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Maud LEMOINE, MD

  Medical Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: March 21, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

BE (1); FR (2); DE (4)