Manhattan HIV/Hepatology Brain Bank

Completed

• Conditions: Hepatitis; HIV

• Registration Number: NCT00300209
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a resource for the AIDS research community. The MHBB was created to act as a center for the provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has recently expanded its goals to assist in the elucidation of liver disease-induced nervous system disorders.

The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and thereby, improving the lives of patients living with HIV and/or Hepatitis C.

Participation is voluntary and can be stopped at any time.

Benefits: This is an observational study; no experimental procedures, devices or drugs are used. All enrolled patients undergo regular examinations by physicians, nurses, and neuropsychologists who specialize in the problems that HIV and HCV can cause.

Taking part in this study may result in the detection of brain, muscle, or spinal cord disease for which treatments may be available. Participants may receive no direct benefit from this study. However, knowledge gained from this research may, in the future, help others who suffer from HIV/AIDS and/or liver disease.

Participants agree to autopsy and organ donation upon demise by signing an Anatomical Gift Consent document.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-09
• Primary Completion: 2002-06
• Study Completion: 2002-06
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

CD4 < 50 on two occasions >12 weeks apart. Hemoglobin <10 G/dL. Albumin <3.2 G/dL.

CMV end-organ disease Disseminated MAC PML AIDS Dementia Complex Wasting (>30% of lean body mass)

Visceral Kaposi's sarcoma Lymphoma-systemic of CNS

CHF Major systemic illness with poor prognosis (as determined by primary physician).

Exclusion Criteria

• <18 years old Not willing to sign an Anatomical Gift Consent for autopsy and organ donation upon demise.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral Load blood level	Baseline	Plasma viral load level

Secondary Outcome Measures

Name	Time	Method
CD4 cell blood level	Baseline

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States