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Home > "C" Clinical Trials Conditions > Consent for Use of Stored Patient Specimens for Future Testing  Consent for Use of Stored Patient Specimens for Future Testing
Consent for Use of Stored Patient Specimens for Future Testing
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood, urine, tissue, and/or other body fluids) in other studies that may include genetic testing at some later date and that are not yet planned. This study also aims to obtain an extra blood sample that will be saved for genetic testing at some later date that is not yet planned. To advance human health, it is important that human biological materials continue to be available to the biomedical research community. During AACTG clinical trials, samples of HBM have been or will be obtained and stored until analyzed. However, some HBM may be left over after protocol completion. Questions may arise after study completion that can be answered only with stored specimens and not with specimens collected after study completion. To improve understanding of HIV and the best way to manage the disease, it is very important that HBM be available to investigators for future analyses that are yet to be determined.
Details: To advance human health, it is critical that human biological materials continue to be available to the biomedical research community. During the performance of past, present, and future AACTG clinical trials, samples of HBM (e.g., blood, other body fluids, tissue, cells, and/or DNA) have been or will be obtained and stored until analyzed, as defined by the particular protocol for which the patient provided consent. However, some HBM may be left over after protocol completion. Valuable opportunities may arise after the design of a study. Many of these opportunities may be addressed only with archived, rather than prospectively collected, HBM. To improve understanding of HIV disease and its optimal management, it is, therefore, critical that HBM be available to investigators for subsequent unspecified analyses. This study involves 2 stages. The initial Pilot Stage is performed at 4 AIDS Clinical Trial Units (ACTUs) and is done to help anticipate and therefore avoid any logistical difficulties related to protocol performance that may occur during large-scale implementation. After completion of the Pilot Stage, the Open Stage begins, in which all Adult ACTUs may participate. All patients are asked to sign the consent and specify whether or not they agree to allow their left-over samples to be used for secondary analyses and/or whether or not they agree to have one 14 ml blood sample drawn under this study for DNA archiving to use for currently unspecified genetic analyses. Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result that arises from secondary testing. Patients who do not agree to either option will indicate this on the informed consent and have no further involvement in this study. Declining consent does not in any way jeopardize participation in any other current or future AACTG clinical trials. Consent may be obtained at the same time the patient is being enrolled into any AACTG clinical trial, at some interval after the patient has entered but is still on an AACTG trial, or at any time after the patient completed participation in an AACTG 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 to obtain permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained for another clinical trial and, therefore, not specified in the original protocol or informed consent documents.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they are: - Able and willing to give written informed consent. - Either currently participating in or have ever participated in an AACTG clinical trial.
Total Enrollment: 50000
Location and Contact Information:
Overall Study Official:
AlastairWood, Study Chair,
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
St Mary's Hosp (Univ of Rochester/Infectious Diseases) *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Christine Fietzer 612-625-1462
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 585-275-2740
Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Mykyelle Crawford 212-305-2665
Univ of Maryland, Institute of Human Virology *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Susan LaSalvia 410-706-2785
Univ of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Michele Downing 415-514-0550
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 46202-5250
United States
Recruiting Beth Zwickl 317-274-8456
Stanford Univ Med Ctr *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
Brigham and Women's Hosp *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
San Mateo AIDS Program / Stanford Univ *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Cornell Clinical Trials Unit - Chelsea Clinic *Recruiting*
New York City, New York, 10011
United States
Recruiting Todd Stroberg 212-746-7198
Ohio State Univ Hosp Clinic *Recruiting*
Columbus, Ohio, 432101228
United States
Recruiting Judith Neidig 614-293-8112
SUNY / Erie County Med Ctr at Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Rachele Cruz 716-898-3933
University of California, Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Boston Med Ctr *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Christine Johnsen 617-414-7831
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Vanderbilt Univ Med Ctr *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Univ of Iowa Hosp and Clinic *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Julie Katseres 319-353-8441
Rush Presbyterian - Saint Luke's Med Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jan Fritsche 312-942-5865
Emory Univ *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Ericka Patrick 404-616-6313
Univ of Puerto Rico *Recruiting*
San Juan, , 365067
Puerto Rico
Recruiting Raquel Colon-Otero 787-767-9192
Willow Clinic / Stanford Univ *Recruiting*
Stanford, California, 94305
United States
Recruiting Debbie Slamowitz 650-723-2804
Community Health Network Inc *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 585-275-2740
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 452670405
United States
Recruiting Tammy Powell 513-584-8373
Harbor General/UCLA *Recruiting*
Torrance, California, 90502
United States
Recruiting Mario Guerrerro 310-222-3848
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 275997215
United States
Recruiting Cheryl Marcus 919-843-8761
Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44106-5083
United States
Recruiting Michael Chance 216-844-8051
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Univ of Miami School of Medicine *Recruiting*
Miami, Florida, 331361013
United States
Recruiting Leslie Thompson 305-243-3838
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Washington Univ School of Medicine *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Michael Klebert 314-454-0058
Moses H Cone Memorial Hosp *Recruiting*
Greensboro, North Carolina, 27401
United States
Recruiting Lisa Dasnoit 336-832-8062
Presbyterian Med Ctr *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Maureen O'Connell 215-349-8092
Univ of Texas, Southwestern Med Ctr of Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Chip Lohner 214-590-0414
The CORE Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Miriam Hosp / Brown Univ *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Mount Sinai Med Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Brown Univ / Miriam Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Harvard (Massachusetts Gen Hosp) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-726-3819
Cornell Univ Med Ctr *Recruiting*
New York City, New York, 10021
United States
Recruiting Valery Hughes 212-746-4393
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Univ of Texas Galveston *Recruiting*
Galveston, Texas, 775550435
United States
Recruiting Carrie Derkowski 409-747-0241
Washington Univ / St Louis Connect Care *No longer recruiting*
St. Louis, Missouri, 63108
United States
No longer recruiting
Univ of Southern California / LA County USC Med Ctr *Recruiting*
Los Angeles, California, 900331079
United States
Recruiting Luis Mendez 323-343-8283
Charles Drew Medical Center *Recruiting*
Los Angeles, California, 90059
United States
Recruiting Deborah Novak 323-563-9322
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Georgetown Univ Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Scott Watson 202-687-7387
Univ of Nebraska Med Ctr *Recruiting*
Omaha, Nebraska, 681985130
United States
Recruiting Frances Meter 402-559-8163
Beth Israel Deaconess - West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
Univ of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Christine Tripoli 412-647-0771
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Additional Information:
Study ID Numbers: ACTG A5128; AACTG A5128
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031408
Other Hiv Infections Studies:
1. Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems
2. Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
3. A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)
4. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults
5. AIDS-Associated Heart Disease -- Incidence and Etiology
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Consent for Use of Stored Patient Specimens for Future Testing
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