Manhattan HIV/Hepatology Brain Bank

NCT00300209 | Completed

• 2 other identifiers: GCO 98-0477R24MH059724
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Viral Load blood level

  Plasma viral load level

  Baseline

Secondary Outcomes (1)

• CD4 cell blood level

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• 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. doi: 10.1001/archneur.61.4.546.

  PMID: 15096404 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum blood

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Susan Morgello, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: September 1, 1998
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)