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

NCT ID: NCT02093754

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-03-31

Brief Summary

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

Detailed Description

This study is a cross-sectional, multicentre study including 7 centres from 3 European countries (Belgium, France, Germany).

The maximum duration of the study for each patient will be 4 months, consisting of:

• a screening visit,
• an inclusion visit to perform the biologic tests and exams necessary for the study, within 1 month after the screening visit,
• a result delivery visit within 1 month after inclusion visit, to disclose results of previous investigations. Patients with one or two non invasive markers suggesting significant fibrosis (≥F2) will be invited for liver biopsy within the next 2 months.
• a "liver biopsy" visit, within 2 months after visit 2, liver biopsy in selected and consented patients

Conditions

HIV Infection; Liver Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

MRI and biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥40 years

2. Infection with HIV-1

3. Cumulative exposure to cART for at least 5 years and currently under cART

4. Viral load < 400 copies/mL

5. CD4 count > 100 CD4/mm3

6. 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

7. Informed consent signed prior to any study procedure

8. To be covered by a medical insurance (only for French centres)

9. 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,
• serum HDL cholesterol < 0,4 g/L (1 mmol/L) for men and < 0,5 g/L (1,3 mmol/L) for women or hypercholesterolemia treatment,
• blood pressure (Diastolic ≥130 mmHg and/or Systolic ≥ 85 mmHg) or antihypertensive treatment
• and/or clinical lipoatrophy and/or lipohypertrophy using clinical questionnaires used and validated in previous published studies (ANRS 121 Hippocampe trial),
• and/or chronic elevated transaminases ≥ 1.5 ULN and / or GGT ≥ 2 ULN confirmed by two blood samples within at least three-month interval over twelve months prior screening visit.

Exclusion Criteria

1. Coinfection with hepatitis B (positive HBs antigen or isolated positive HBc antibody with positive PCR)

2. Positive HCV serology

3. Coinfection HIV-1 and HIV-2

4. Use of intravenous drugs within the last six months

5. Excessive alcohol intake (male > 50 g/d, female > 40 g/d)

6. 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

7. 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

8. Active opportunistic infection except for candida oesophagitis

9. Current Cancer

10. Pregnancy

11. Decompensated heart failure

12. Subject under legal guardianship

13. Inability to give informed consent or incapacitation

14. Contra-indication to MRI: pace-maker, neurovascular surgery, intraocular materials, cochlear implant, severe claustrophobia

15. Participation in another study with an ongoing exclusion period at screening

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maud LEMOINE, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Research Council

Locations

CHU Brussels

Brussels, , Belgium

Hôpital la Salpêtrière

Paris, , France

Hôpital Saint Antoine

Paris, , France

Medical Center for Infectious Diseases

Berlin, , Germany

Center for HIV and Hepato-Gastroenterology

Düsseldorf, , Germany

University Medical Center

Hamburg, , Germany

Hannover Medical School

Hanover, , Germany

Countries

Belgium; France; Germany

Other Identifiers

2012-A01670-43

Identifier Type: OTHER

Identifier Source: secondary_id

ECHAM

Identifier Type: -

Identifier Source: org_study_id