Manhattan HIV/Hepatology Brain Bank

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300209
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : March 17, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease
HIV Hepatitis

Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Manhattan HIV/Hepatology Brain Bank
Study Start Date : September 1998
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Viral Load blood level [ Time Frame: Baseline ]
    Plasma viral load level

Secondary Outcome Measures :
  1. CD4 cell blood level [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
plasma and serum blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HIV infection with advanced disease who display signs of distal sensory polyneuropathy, and who consent to postmortem organ donation.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300209

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Principal Investigator: Susan Morgello, MD Icahn School of Medicine at Mount Sinai