Consent for Use of Stored Patient Specimens for Future Testing

This study is currently recruiting participants.
Verified June 2013 by AIDS Clinical Trials Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00031408
First received: March 5, 2002
Last updated: June 17, 2013
Last verified: June 2013

March 5, 2002
June 17, 2013
March 2002
December 2016   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00031408 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Consent for Use of Stored Patient Specimens for Future Testing
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and tissue samples

Non-Probability Sample

HIV-infected individuals

HIV Infections
Not Provided
Not Provided
Bronke C, Almeida CA, McKinnon E, Roberts SG, Keane NM, Chopra A, Carlson JM, Heckerman D, Mallal S, John M. HIV escape mutations occur preferentially at HLA-binding sites of CD8 T-cell epitopes. AIDS. 2013 Mar 27;27(6):899-905. doi: 10.1097/QAD.0b013e32835e1616.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Not Provided
United States,   Puerto Rico
 
NCT00031408
ACTG A5128, 1U01AI068636, AACTG A5128
Not Provided
AIDS Clinical Trials Group
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: David W. Haas, MD Vanderbilt University
AIDS Clinical Trials Group
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP