Consent for Use of Stored Patient Specimens for Future Testing

September 12, 2023 updated by: AIDS Clinical Trials Group

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 365067
        • Recruiting
        • Univ of Puerto Rico
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 900331079
        • Recruiting
        • Univ of Southern California / LA County USC Med Ctr
        • Contact:
      • Los Angeles, California, United States, 90059
        • Recruiting
        • Charles Drew Medical Center
        • Contact:
      • Los Angeles, California, United States, 90095
      • San Diego, California, United States, 92103
        • Recruiting
        • Univ of California, San Diego
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • Univ of California San Francisco
        • Contact:
      • Stanford, California, United States, 943055107
        • Recruiting
        • San Mateo AIDS Program / Stanford Univ
        • Contact:
      • Stanford, California, United States, 943055107
      • Stanford, California, United States, 94305
        • Recruiting
        • Willow Clinic / Stanford Univ
        • Contact:
      • Torrance, California, United States, 90502
        • Recruiting
        • Harbor General/UCLA
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80262
        • Recruiting
        • Univ of Colorado Health Sciences Ctr
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown Univ Med Ctr
        • Contact:
    • Florida
      • Miami, Florida, United States, 331361013
        • Recruiting
        • Univ of Miami School of Medicine
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Univ
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Univ Med School
        • Contact:
          • Baiba L. Berzins
          • Phone Number: 312-695-5012
          • Email: baiba@nwu.edu
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush Presbyterian - Saint Luke's Med Ctr
        • Contact:
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5250
        • Recruiting
        • Indiana Univ Hosp
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Methodist Hosp of Indiana / Life Care Clinic
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Wishard Hosp
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504)
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Univ of Maryland, Institute of Human Virology
        • Contact:
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hosp
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Harvard (Massachusetts Gen Hosp)
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Med Ctr
        • Contact:
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Brigham and Women's Hosp
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Univ of Minnesota
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Recruiting
        • Washington Univ / St Louis Connect Care
        • Contact:
      • Saint Louis, Missouri, United States, 63108
        • Recruiting
        • Washington Univ School of Medicine
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Recruiting
        • Specialty Care Center CRS 1505
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • New Jersey Medical School- Adult CRS (31477)
        • Principal Investigator:
          • Sally Hodder, MD
        • Contact:
    • New York
      • Buffalo, New York, United States, 14215
      • New York, New York, United States, 10003
        • Recruiting
        • Beth Israel Med Ctr
        • Contact:
      • New York, New York, United States, 10011
        • Recruiting
        • Cornell Clinical Trials Unit - Chelsea Clinic
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • Bellevue Hosp / New York Univ Med Ctr
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Cornell Univ Med Ctr
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • The Cornell Clinical Trials Unit
        • Contact:
      • New York, New York, United States, 10029
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia Presbyterian Med Ctr
        • Contact:
      • Rochester, New York, United States, 14642
      • Rochester, New York, United States, 14642
      • Rochester, New York, United States, 14642
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Wake County Health and Human Services CRS (30076)
        • Contact:
          • Cheryl J. Marcus, RN, BSN
          • Phone Number: 919-843-8761
          • Email: cjm@med.unc.edu
      • Chapel Hill, North Carolina, United States, 275997215
        • Recruiting
        • Univ of North Carolina
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Univ Med Ctr
        • Contact:
      • Greensboro, North Carolina, United States, 27401
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Recruiting
        • Univ of Cincinnati
        • Contact:
      • Cleveland, Ohio, United States, 44106-5083
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210-1228
        • Recruiting
        • Ohio State Univ Hosp Clinic
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • The Research & Education Group-Portland CRS (31474)
        • Contact:
          • Norma Martinez, RN, BSc, BSN, CCRC
          • Phone Number: 1-503-229-8428
          • Email: norma@reg.org
        • Principal Investigator:
          • James H. Sampson, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, ACTU
        • Contact:
        • Principal Investigator:
          • Pablo Tebas, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Univ of Pittsburgh
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Miriam Hosp / Brown Univ
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Dallas, Texas, United States, 75235-9173
      • Dallas, Texas, United States, 75390
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
        • Contact:
        • Principal Investigator:
          • Daniel E. Nixon, DO
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Univ of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

HIV-infected individuals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Clinical Trials Group

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: David W. Haas, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2002

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 5, 2002

First Submitted That Met QC Criteria

March 5, 2002

First Posted (Estimated)

March 6, 2002

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5128
  • 1U01AI068636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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