A multi-investigator/institutional DNA bank for AIDS-related human genetic studies: AACTG Protocol A5128.
BACKGROUND
An understanding of the relationships among allelic variability and clinical outcomes will be critical if HIV-infected patients are to benefit from the explosion in knowledge in human genomics. Human DNA banks must allow future analyses while addressing confidentiality, ethical, and regulatory issues.


METHODS
A multidisciplinary group of clinical investigators, ethicists, data managers, regulatory specialists, and community representatives developed Adult AIDS Clinical Trials Group (AACTG) Protocol A5128. Participants in past or present AACTG clinical trials may contribute DNA. Extraction from whole blood is performed at a central laboratory, where participants' unique identifiers are replaced by randomly assigned identifiers prior to DNA storage. To identify genotype-phenotype relationships, genetic assay results can be temporarily linked to clinical trials data.


RESULTS
Institutional review boards in 21 states and Puerto Rico have approved Protocol A5128, and accrual is ongoing. Of the first 4,247 enrollees, 82% are male, 56% are white, 26% are African American, and 15% are Hispanic. Because participants may participate in multiple AACTG protocols, these represent 11,424 cases in 324 different AACTG studies and substudies, with at least 100 participants from 24 different studies. Studies exploring specific genotype-phenotype relationships are underway.


CONCLUSIONS
The AACTG DNA bank will be an important resource for genomic discovery relevant to HIV therapy.
Haas
David W
DW
Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, Tennessee 37203, USA. david.w.haas@vanderbilt.edu
Wilkinson
Grant R
GR
Kuritzkes
Daniel R
DR
Richman
Douglas D
DD
Nicotera
Janet
J
Mahon
Laura F
LF
Sutcliffe
Cara
C
Siminski
Sue
S
Andersen
Janet
J
Coughlin
Kristine
K
Clayton
Ellen W
EW
Haines
Jonathan
J
Marshak
Ann
A
Saag
Michael
M
Lawrence
Jody
J
Gustavson
Jeffrey
J
Anne Bennett
Jo
J
Christensen
Rolf
R
Matula
Margaret A
MA
Wood
Alastair J J
AJ
D000163:Acquired Immunodeficiency Syndrome / Q000235:genetics*; D000328:Adult; D018070:Biological Specimen Banks / Q000941:ethics*; D002985:Clinical Protocols; D003219:Confidentiality; D030541:Databases, Genetic / Q000941:ethics*; D005260:Female; D006801:Humans; D008297:Male; D009938:Organizations / Q000941:ethics / Q000458:organization & administration; D010597:Pharmacogenetics / Q000941:ethics*; D012107:Research Design; D014481:United States