Consent for Use of Stored Patient Specimens for Future 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.

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