Consent for Use of Stored Patient Specimens for Future Testing
- Conditions
- HIV Infections
- Registration Number
- NCT00031408
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30000
- Parent or guardian willing to give informed consent, if applicable
- Either currently participating in or have ever participated in an AACTG clinical trial
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Charles Drew Medical Center
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of California, San Diego
🇺🇸San Diego, California, United States
Univ of California San Francisco
🇺🇸San Francisco, California, 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
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Emory Univ
🇺🇸Atlanta, Georgia, 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
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
Univ of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Washington Univ / St Louis Connect Care
🇺🇸Saint Louis, Missouri, United States
Washington Univ School of Medicine
🇺🇸St Louis, Missouri, United States
Specialty Care Center CRS 1505
🇺🇸Omaha, Nebraska, United States
New Jersey Medical School- Adult CRS (31477)
🇺🇸Newark,, New Jersey, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
The Cornell Clinical Trials Unit
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, 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
Wake County Health and Human Services CRS (30076)
🇺🇸Chapel Hill, North Carolina, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Greensboro CRS
🇺🇸Greensboro, North Carolina, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic (A2508)
🇺🇸Cleveland, Ohio, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
The Research & Education Group-Portland CRS (31474)
🇺🇸Portland, Oregon, 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
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Dallas VA Medical Center (3752)
🇺🇸Dallas, Texas, United States
Univ of Texas, Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
🇺🇸Richmond, Virginia, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico