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Consent for Use of Stored Pat...

Consent for Use of Stored Patient Specimens for Future Testing

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

17444 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-02-13

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David W. Haas, MD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

Charles Drew Medical Center

Los Angeles, California, United States

Site Status

UCLA CARE Ctr

Los Angeles, California, United States

Site Status

Univ of California, San Diego

San Diego, California, United States

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Univ of California San Francisco

San Francisco, California, United States

Site Status

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

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Stanford Univ Med Ctr

Stanford, California, United States

Site Status

Willow Clinic / Stanford Univ

Stanford, California, United States

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Harbor General/UCLA

Torrance, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Emory Univ

Atlanta, Georgia, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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The CORE Ctr

Chicago, Illinois, United States

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Indiana Univ Hosp

Indianapolis, Indiana, United States

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Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States

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Wishard Hosp

Indianapolis, Indiana, United States

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Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504)

Iowa City, Iowa, United States

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Univ of Maryland, Institute of Human Virology

Baltimore, Maryland, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Boston Med Ctr

Boston, Massachusetts, United States

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Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

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Brigham and Women's Hosp

Boston, Massachusetts, United States

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Univ of Minnesota

Minneapolis, Minnesota, United States

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Washington Univ / St Louis Connect Care

St Louis, Missouri, United States

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Washington Univ School of Medicine

St Louis, Missouri, United States

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Specialty Care Center CRS 1505

Omaha, Nebraska, United States

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New Jersey Medical School- Adult CRS (31477)

Newark, New Jersey, United States

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