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

March 7, 2006
March 8, 2006
March 17, 2016
September 1998
June 2002   (Final data collection date for primary outcome measure)
Viral Load blood level [ Time Frame: Baseline ]
Plasma viral load level
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Complete list of historical versions of study NCT00300209 on Archive Site
CD4 cell blood level [ Time Frame: Baseline ]
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Manhattan HIV/Hepatology Brain Bank
Manhattan HIV/Hepatology Brain Bank

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
plasma and serum blood
Non-Probability Sample
Patients with HIV infection with advanced disease who display signs of distal sensory polyneuropathy, and who consent to postmortem organ donation.
  • HIV
  • Hepatitis
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Morgello S, Estanislao L, Simpson D, Geraci A, DiRocco A, Gerits P, Ryan E, Yakoushina T, Khan S, Mahboob R, Naseer M, Dorfman D, Sharp V; Manhattan HIV Brain Bank. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol. 2004 Apr;61(4):546-51.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2002
June 2002   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
GCO 98-0477
R24MH059724 ( U.S. NIH Grant/Contract )
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Icahn School of Medicine at Mount Sinai
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
Icahn School of Medicine at Mount Sinai
March 2016