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Manhattan HIV/Hepatology Brain Bank

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00300209
First received: March 7, 2006
Last updated: March 16, 2016
Last verified: March 2016

March 7, 2006
March 16, 2016
September 1998
June 2002   (final data collection date for primary outcome measure)
Viral Load blood level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Plasma viral load level
Not Provided
Complete list of historical versions of study NCT00300209 on ClinicalTrials.gov Archive Site
CD4 cell blood level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
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
Not Provided
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
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.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00300209
GCO 98-0477, R24MH059724
Not Provided
Not Provided
Not Provided
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP