Manhattan HIV/Hepatology Brain Bank

HIV Clinical Trial

Official title:

Manhattan HIV/Hepatology Brain Bank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300209
• Other study ID #: GCO 98-0477
• Secondary ID: R24MH059724
• Status: Completed
• Phase: N/A
• First received: March 7, 2006
• Last updated: March 16, 2016
• Start date: September 1998
• Est. completion date: June 2002

Study information

• Verified date: March 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• HIV

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Load blood level	Plasma viral load level	Baseline	No
Secondary	CD4 cell blood level		Baseline	No