Consent for Use of Stored Patient Specimens for Future Testing

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Biospecimen Retention:   Samples With DNA

Blood and tissue samples


Estimated Enrollment: 20000
Study Start Date: March 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected individuals

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031408

  Hide Study Locations
Locations
United States, California
Charles Drew Medical Center Active, not recruiting
Los Angeles, California, United States, 90059
UCLA CARE Ctr Recruiting
Los Angeles, California, United States, 90095
Contact: Susan McCarthy    310-206-8029    smccarthy@mednet.ucla.edu   
Univ of Southern California / LA County USC Med Ctr Recruiting
Los Angeles, California, United States, 900331079
Contact: Luis Mendez    323-343-8283    lmendez@hsc.usc.edu   
University of California, Davis Med Ctr Active, not recruiting
Sacramento, California, United States, 95814
Univ of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Jill Kunkel    619-543-8080    jkunkel@ucsd.edu   
Univ of California San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Jay Dwyer    415-514-0550 ext 358    jdwyer@php.ucsf.edu   
Willow Clinic / Stanford Univ Active, not recruiting
Stanford, California, United States, 94305
San Mateo AIDS Program / Stanford Univ Active, not recruiting
Stanford, California, United States, 943055107
Stanford Univ Med Ctr Recruiting
Stanford, California, United States, 943055107
Contact: Debbie Slamowitz    650-723-2804    dslam@leland.stanford.edu   
Harbor General/UCLA Recruiting
Torrance, California, United States, 90502
Contact: Mario Guerrerro    310-222-3848    mguerrerro@rei.edu   
United States, Colorado
Univ of Colorado Health Sciences Ctr Recruiting
Denver, Colorado, United States, 80262
Contact: M. Graham Ray    303-372-5535    graham.ray@uchsc.edu   
United States, District of Columbia
Georgetown Univ Med Ctr Recruiting
Washington, District of Columbia, United States, 20007
Contact: Scott P. Watson    202-687-7387    spw3@georgetown.edu   
United States, Florida
Univ of Miami School of Medicine Recruiting
Miami, Florida, United States, 331361013
Contact: Leslie Thompson    305-243-3838    lthomps@gate.net   
United States, Georgia
Emory Univ Recruiting
Atlanta, Georgia, United States, 30308
Contact: Ericka Patrick    404-616-6313    erpatri@emory.edu   
United States, Hawaii
Univ of Hawaii Active, not recruiting
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School Recruiting
Chicago, Illinois, United States, 60611
Contact: Baiba L. Berzins    312-695-5012    baiba@nwu.edu   
Rush Presbyterian - Saint Luke's Med Ctr Recruiting
Chicago, Illinois, United States, 60612
Contact: Jan Fritsche    312-942-5865    jfrits@rush.edu   
The CORE Ctr Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp Active, not recruiting
Indianapolis, Indiana, United States, 46202-5250
Methodist Hosp of Indiana / Life Care Clinic Active, not recruiting
Indianapolis, Indiana, United States, 46202
Wishard Hosp Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Scott Hamilton    317-630-6023    shamilt2@iupui.edu   
United States, Iowa
Univ of Iowa Hosp and Clinic Recruiting
Iowa City, Iowa, United States, 52242
Contact: Julie Katseres    319-353-8441    katseres.julie@fstrf.org   
United States, Maryland
Johns Hopkins Hosp Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charles Raines    410-614-4487    craines410@aol.com   
Univ of Maryland, Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201
Contact: Susan LaSalvia    410-706-2785    lasalvia@umbi.umd.edu   
United States, Massachusetts
Harvard (Massachusetts Gen Hosp) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Teri Flynn    617-726-3819    tflynn@partners.org   
Beth Israel Deaconess - West Campus Recruiting
Boston, Massachusetts, United States, 02215
Contact: Helen Fitch    617-632-0785    hfitch@caregroup.harvard.edu   
Boston Med Ctr Recruiting
Boston, Massachusetts, United States, 02118
Contact: Christine Johnsen    617-414-7831    chjohnse@bmc.org   
Brigham and Women's Hosp Recruiting
Boston, Massachusetts, United States, 02215
Contact: Carolyn Koziol    617-732-5635    ckoziol@partners.org   
Boston Medical Center (Harvard) Recruiting
Boston, Massachusetts, United States, 02118
Contact: Betsy Adams, RN, BSN    617-414-7082    betsy.adams@bmc.org   
United States, Minnesota
Univ of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington Univ / St Louis Connect Care Active, not recruiting
Saint Louis, Missouri, United States, 63108
Washington Univ School of Medicine Recruiting
St Louis, Missouri, United States, 63108
Contact: Michael Klebert    314-454-0058    mklebert@imgate.wustl.edu   
United States, Nebraska
Univ of Nebraska Med Ctr Active, not recruiting
Omaha, Nebraska, United States, 681985130
United States, New Jersey
New Jersey Medical School- Adult Clinical Research Ctr. CRS Recruiting
Newark,, New Jersey, United States, 07103
Contact: Nancy Reilly    973-972-1268    reillyna@umdnj.edu   
Principal Investigator: Sally Hodder, MD         
United States, New York
SUNY / Erie County Med Ctr at Buffalo Terminated
Buffalo, New York, United States, 14215
Bellevue Hosp / New York Univ Med Ctr Recruiting
New York, New York, United States, 10016
Contact: Maura Laverty    212-263-6565    maura.laverty@med.nyu.edu   
Mount Sinai Med Ctr Active, not recruiting
New York, New York, United States, 10029
Cornell Univ Med Ctr Active, not recruiting
New York, New York, United States, 10021
The Cornell Clinical Trials Unit Recruiting
New York, New York, United States, 10021
Contact: Valery Hughes, NP    212-746-4393    vah9001@nyp.org   
Beth Israel Med Ctr Recruiting
New York, New York, United States, 10003
Contact: Ann Marshak    212-420-4432    marshak.ann@fstrf.org   
Columbia Presbyterian Med Ctr Recruiting
New York, New York, United States, 10032
Contact: Mykyelle Crawford    212-305-2665    mc675@columbia.edu   
Cornell Clinical Trials Unit - Chelsea Clinic Recruiting
New York, New York, United States, 10011
Contact: Todd Stroberg    212-746-7198    tstrober@med.cornell.edu   
St Mary's Hosp (Univ of Rochester/Infectious Diseases) Recruiting
Rochester, New York, United States, 14642
Contact: Carol Greisberger    716-275-5871    carol_greisberger@urmc.rochester.edu   
Community Health Network Inc Recruiting
Rochester, New York, United States, 14642
Contact: Carol Greisberger    585-275-2740    carol_greisberger@urmc.rochester.edu   
Univ of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Carol Greisberger    585-275-2740    carol_greisberger@urmc.rochester.edu   
United States, North Carolina
Univ of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 275997215
Contact: Cheryl Marcus    919-843-8761    cjm@med.unc.edu   
Wake County Department of Health Active, not recruiting
Chapel Hill, North Carolina, United States, 27514
Duke Univ Med Ctr Recruiting
Durham, North Carolina, United States, 27710
Contact: Suzanne Aycock    919-684-8216    aycoc001@mc.duke.edu   
Moses H Cone Memorial Hosp Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Lisa Dasnoit    336-832-8062    lisa.dasnoit@mosescone.com   
United States, Ohio
Univ of Cincinnati Recruiting
Cincinnati, Ohio, United States, 452670405
Contact: Tammy Powell    513-584-8373    powelltm@email.uc.edu   
Case Western Reserve Univ Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michael Chance    216-844-8051    chance.michael@clevelandactu.org   
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44106-5083
Ohio State Univ Hosp Clinic Recruiting
Columbus, Ohio, United States, 43210-1228
Contact: Todd Lusch    614-293-8112    todd.lusch@osumc.edu   
United States, Oregon
The Research & Education Group-Portland CRS Recruiting
Portland, Oregon, United States, 97210
Contact: Norma Martinez, RN, BSc, BSN, CCRC    1-503-229-8428    norma@reg.org   
Principal Investigator: James H. Sampson, MD         
United States, Pennsylvania
Presbyterian Med Ctr Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen O'Connell    215-349-8092    maureen.oconnell@uphs.upenn.edu   
Univ of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania, Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph Quinn, RN    215-349-8092    joseph.quinn@uphs.upenn.edu   
University of Pennsylvania, ACTU Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph Quinn, RN    215-349-8092    joseph.quinn@uphs.upenn.edu   
Principal Investigator: Pablo Tebas, MD         
Univ of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christine Tripoli    412-647-0771    tripolica@msx.upmc.edu   
United States, Rhode Island
Miriam Hosp / Brown Univ Recruiting
Providence, Rhode Island, United States, 02906
Contact: Joan Gormley    401-793-4396    jgormley@lifespan.org   
Brown Univ / Miriam Hosp Recruiting
Providence, Rhode Island, United States, 02906
Contact: Joan Gormley    401-793-4396    jgormley@lifespan.org   
United States, Tennessee
Vanderbilt Univ Med Ctr Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas VA Medical Center Active, not recruiting
Dallas, Texas, United States, 75235-9173
Univ of Texas, Southwestern Med Ctr of Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Chip Lohner    214-590-0414    chip.lohner@utsouthwestern.edu   
Univ of Texas Galveston Recruiting
Galveston, Texas, United States, 775550435
Contact: Carrie Derkowski    409-747-0241    caderkow@utmb.edu   
United States, Virginia
Virginia Commonwealth Univ. Medical Ctr. CRS Not yet recruiting
Richmond, Virginia, United States, 23219
Contact: Vinnie E. Mitchell    804-828-2477    vemitche@hsc.vcu.edu   
Principal Investigator: Daniel E. Nixon, DO         
United States, Washington
Univ of Washington Active, not recruiting
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico Recruiting
San Juan, Puerto Rico, 365067
Contact: Raquel Colon-Otero    787-767-9192    racolon@rcm.upr.edu   
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: David W. Haas, MD Vanderbilt University
  More Information

Additional Information:
No publications provided by AIDS Clinical Trials Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00031408     History of Changes
Other Study ID Numbers: ACTG A5128, 1U01AI068636, AACTG A5128
Study First Received: March 5, 2002
Last Updated: July 8, 2014
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Specimen Handling
Blood
Informed Consent
Genetic Screening

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014