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Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

Keywords

HIV Infections Specimen Handling Blood Informed Consent Genetic Screening

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

Locations

  • University of California, Davis Med Ctr in progress, not accepting new patients
    Sacramento, California, 95814, USA
  • Willow Clinic / Stanford Univ in progress, not accepting new patients
    Stanford, California, 94305, USA
  • Univ of Southern California / LA County USC Med Ctr accepting new patients
    Los Angeles, California, 900331079, USA
  • Charles Drew Medical Center in progress, not accepting new patients
    Los Angeles, California, 90059, USA
  • UCLA CARE Ctr accepting new patients
    Los Angeles, California, 90095, USA
  • Univ of California, San Diego accepting new patients
    San Diego, California, 92103, USA
  • San Mateo AIDS Program / Stanford Univ in progress, not accepting new patients
    Stanford, California, 943055107, USA
  • Stanford Univ Med Ctr accepting new patients
    Stanford, California, 943055107, USA
  • Harbor General/UCLA accepting new patients
    Torrance, California, 90502, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Clinical Trials Group
ID
NCT00031408
Study Type
Observational
Last Updated
January 2017
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