Consent for Use of Stored Patient Specimens for Future Testing

Recruiting

• 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.

Study Timeline

• Study Start: 2002-02-13
• Study First Submitted: 2002-03-05
• Study First Submitted QC: 2002-03-05
• Study First Posted: 2002-03-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

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