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NCT00031408 Clinical Trial

Consent for Use of Stored Patient Specimens for Future Testing

HIV Infections Clinical Trial

Official title:
Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00031408
Other study ID # ACTG A5128
Secondary ID 1U01AI068636
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2002
Est. completion date December 31, 2027

Study information
Verified date September 2023
Source AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.

Description:

During past, present, and future Adult AIDS Clinical Trials Group (AACTG) clinical trials, samples of HBM (e.g., blood, other body fluids and tissues) have been or will be obtained and stored until analyzed, as defined by the particular trial for which the patient provided consent. Some HBM may be left over after a trial is completed. Important questions may arise during the design of a study; some of these questions may be addressed only with archived (rather than prospectively collected) HBMs. To improve understanding of HIV disease and its optimal management, it is critical that HBMs be available to investigators for subsequent unspecified analyses. All patients are asked to sign the informed consent form and specify whether or not they agree to allow their leftover samples to be used for secondary analyses and whether or not they agree to have one 14 ml blood sample drawn in this study for DNA archiving for use in currently unspecified genetic analyses. Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result from secondary testing. Patients who do not agree to either option will indicate this on the informed consent and will have no further involvement in this study. Declining consent does not in any way jeopardize participation in any other current or future ACTG clinical trial. Consent may be obtained at the same time the patient is being enrolled into any ACTG clinical trial, at some interval after the patient has entered but is still participating in a trial, or at any time after the patient has completed participation in a trial. The goal of this study is to allow archived HBM to be used for research purposes while protecting the identity of patients from whom such samples were obtained. The focus is on obtaining permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained.

Recruitment information / eligibility
Status Recruiting
Enrollment 30000
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Parent or guardian willing to give informed consent, if applicable - Either currently participating in or have ever participated in an AACTG clinical trial

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Univ Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Maryland, Institute of Human Virology Baltimore Maryland
United States Beth Israel Deaconess - West Campus Boston Massachusetts
United States Boston Med Ctr Boston Massachusetts
United States Brigham and Women's Hosp Boston Massachusetts
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Wake County Health and Human Services CRS (30076) Chapel Hill North Carolina
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States The CORE Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States Cleveland Clinic (A2508) Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Dallas VA Medical Center (3752) Dallas Texas
United States Univ of Texas, Southwestern Med Ctr of Dallas Dallas Texas
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States Greensboro CRS Greensboro North Carolina
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States Wishard Hosp Indianapolis Indiana
United States Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504) Iowa City Iowa
United States Charles Drew Medical Center Los Angeles California
United States UCLA CARE Ctr Los Angeles California
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Univ of Minnesota Minneapolis Minnesota
United States Vanderbilt Univ Med Ctr Nashville Tennessee
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Clinical Trials Unit - Chelsea Clinic New York New York
United States Cornell Univ Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States The Cornell Clinical Trials Unit New York New York
United States New Jersey Medical School- Adult CRS (31477) Newark New Jersey
United States Specialty Care Center CRS 1505 Omaha Nebraska
United States Penn Therapeutics CRS (6201) Philadelphia Pennsylvania
United States Presbyterian Med Ctr Philadelphia Pennsylvania
United States Univ of Pennsylvania Philadelphia Pennsylvania
United States University of Pennsylvania, ACTU Philadelphia Pennsylvania
United States Univ of Pittsburgh Pittsburgh Pennsylvania
United States The Research & Education Group-Portland CRS (31474) Portland Oregon
United States Miriam Hosp / Brown Univ Providence Rhode Island
United States Virginia Commonwealth Univ. Medical Ctr. CRS (31475) Richmond Virginia
United States Community Health Network Inc Rochester New York
United States St Mary's Hosp (Univ of Rochester/Infectious Diseases) Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States Washington Univ / St Louis Connect Care Saint Louis Missouri
United States Washington Univ School of Medicine Saint Louis Missouri
United States Univ of California, San Diego San Diego California
United States Univ of California San Francisco San Francisco California
United States Univ of Washington Seattle Washington
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Willow Clinic / Stanford Univ Stanford California
United States Harbor General/UCLA Torrance California
United States Georgetown Univ Med Ctr Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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