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Trial record 1 of 1 for:    A5128
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Consent for Use of Stored Patient Specimens for Future Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00031408
Recruitment Status : Active, not recruiting
First Posted : March 6, 2002
Last Update Posted : August 3, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

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.

Condition or disease
HIV Infections

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.

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses
Actual Study Start Date : February 13, 2002
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Biospecimen Retention:   Samples With DNA
Blood and tissue samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected individuals
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031408


Locations
Hide Hide 63 study locations
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United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Charles Drew Medical Center
Los Angeles, California, United States, 90059
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of California, San Diego
San Diego, California, United States, 92103
Univ of California San Francisco
San Francisco, California, United States, 94110
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Willow Clinic / Stanford Univ
Stanford, California, United States, 94305
Harbor General/UCLA
Torrance, California, United States, 90502
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202-5250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Wishard Hosp
Indianapolis, Indiana, United States, 46202
United States, Iowa
Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504)
Iowa City, Iowa, United States, 52242
United States, Maryland
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02215
United States, Minnesota
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington Univ / St Louis Connect Care
Saint Louis, Missouri, United States, 63108
Washington Univ School of Medicine
Saint Louis, Missouri, United States, 63108
United States, Nebraska
Specialty Care Center CRS 1505
Omaha, Nebraska, United States, 681985130
United States, New Jersey
New Jersey Medical School- Adult CRS (31477)
Newark, New Jersey, United States, 07103
United States, New York
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Beth Israel Med Ctr
New York, New York, United States, 10003
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, United States, 10011
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Cornell Univ Med Ctr
New York, New York, United States, 10021
The Cornell Clinical Trials Unit
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Community Health Network Inc
Rochester, New York, United States, 14642
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States, 14642
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Wake County Health and Human Services CRS (30076)
Chapel Hill, North Carolina, United States, 27514
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Greensboro CRS
Greensboro, North Carolina, United States, 27401
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Cleveland Clinic (A2508)
Cleveland, Ohio, United States, 44106-5083
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 43210-1228
United States, Oregon
The Research & Education Group-Portland CRS (31474)
Portland, Oregon, United States, 97210
United States, Pennsylvania
Penn Therapeutics CRS (6201)
Philadelphia, Pennsylvania, United States, 19104
Presbyterian Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Univ of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania, ACTU
Philadelphia, Pennsylvania, United States, 19104
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas VA Medical Center (3752)
Dallas, Texas, United States, 75235-9173
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
Richmond, Virginia, United States, 23219
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 365067
Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: David W. Haas, MD Vanderbilt University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00031408    
Other Study ID Numbers: ACTG A5128
1U01AI068636 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2002    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: April 2020
Keywords provided by AIDS Clinical Trials Group:
Specimen Handling
Blood
Informed Consent
Genetic Screening
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases