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Collection of Blood Samples From HIV Infected People

Primary Purpose

HIV Infections

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Genetic Testing, Genomics, Human Genetic Factors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial Signed informed consent

Sites / Locations

  • Dr. M. Estes Med. Practice CRS
  • Dr. Robert Scott Med. Practice CRS
  • East Bay AIDS Ctr. CRS
  • Dr. Shawn Hassler Med. Practice CRS
  • Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
  • Dr. Virginia Cafaro Med. Practice CRS
  • Dr. William Owen Med. Practice CRS
  • Castro-Mission Health Ctr. CRS
  • St. Mary's Med. Ctr. of San Francisco CRS
  • San Francisco VAMC, Infectious Diseases Clinic CRS
  • UCSF PHP, Gen. Internal Medicine Practice CRS
  • Beacon Clinic at Boulder CRS
  • Denver Infectious Diseases Consultants CRS
  • Kaiser Permanente of Denver CRS
  • Univ. of Colorado Health Science Ctr. CRS
  • Denver Public Health CRS - INSIGHT
  • Denver Public Health CRS
  • Eastside Family Health Ctr. CRS
  • APEX Family Medicine CRS
  • South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
  • Western Infectious Disease Consultants CRS
  • Yale Univ. School of Medicine, NE ProACT - New Haven CRS
  • Georgetown Wellness Clinic
  • Christiana Care Health Services HIV Program CRS
  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
  • Klein & Slotten Medical Associates CRS
  • Univ. of Illinois Family Ctr. for Infectious Disease CRS
  • Lakeshore Infectious Disease Associates CRS
  • North Side Family Medicine CRS
  • Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
  • James Osterberger, MD (Private Med. Practice) CRS
  • Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
  • Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
  • New Orleans VAMC CRS
  • CRI-Boston CRS
  • CRI-Springfield CRS
  • Harper Hosp., Detroit CRS
  • Wayne State Univ. CRS
  • Wayne State Univ. INSIGHT CRS
  • Henry Ford Hosp. CRS
  • Henry Ford Hosp., Div. of Infectious Disease INSIGHT CRS
  • Detroit Community Health Connection, Inc. CRS
  • Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS
  • Michigan State Univ., Infectious Disease Clinic CRS
  • Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
  • Cooper Univ. Hosp. CRS
  • ID Care Inc. - Hillsborough CRS
  • Jersey Shore Univ. Med. Ctr. CRS
  • Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
  • New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Raritan Bay Med. Ctr., Perth Amboy Division CRS
  • ID Care - Randolph CRS
  • Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
  • The Early Intervention Program at Kennedy Hosp. CRS
  • Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
  • Bronx-Lebanon Hosp. Ctr. CRS
  • Montefiore Med. Ctr., AIDS Ctr. CRS
  • St. Vincent Hosp. & Med. Ctr. CRS
  • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
  • Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS
  • Multnomah County Health Dept., HIV Health Services Ctr. CRS
  • Legacy Clinic Good Samaritan CRS
  • The Research & Education Group-Portland CRS
  • Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
  • Kaiser Immune Deficiency Clinic of Portland CRS
  • Legacy Clinic Emanuel CRS
  • Legacy Clinic Northeast CRS
  • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
  • Temple Univ. School of Medicine CRS
  • Baylor College of Medicine, Thomas St. Clinic CRS
  • Houston AIDS Research Team CRS
  • Michael E. DeBakey VAMC CRS
  • Thomas Street Clinic CRS
  • MediCorp, Infectious Disease Associates CRS
  • Petersburg Health Care Alliance CRS
  • Vernon Harris East End Community Health Ctr. CRS
  • CrossOver Health Ctr. CRS
  • South Richmond Health Care Ctr. CRS
  • Hunter Holmes McGuire VAMC CRS
  • VCU Health Systems, Infectious Disease Clinic CRS
  • Virginia Commonwealth Univ. Medical Ctr. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 15, 2004
Last Updated
May 16, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00096772
Brief Title
Collection of Blood Samples From HIV Infected People
Official Title
Collection and Use of Blood For Genetic and Other Related Analyses (The GENOMICS Protocol)
Study Type
Observational

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to collect blood samples from HIV infected individuals for use in future genetic studies.
Detailed Description
Genetic differences among people with HIV may account for differences in disease progression and response to antiretroviral therapy. The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) was created to conduct studies in HIV infected communities and particularly in people of color, women, and injection drug users. This study will collect whole blood samples from HIV infected individuals. The samples will be used in future CPCRA studies comparing human genetic factors with clinical data from other CPCRA studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Genetic Testing, Genomics, Human Genetic Factors

7. Study Design

Enrollment
2502 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Whole blood

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial Signed informed consent
Study Population Description
Study participants will be selected from those who have given informed consent for participation in a qualifying CPCRA clinical trial.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Uy, MD
Organizational Affiliation
AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. M. Estes Med. Practice CRS
City
Mill Valley
State/Province
California
ZIP/Postal Code
94941-3013
Country
United States
Facility Name
Dr. Robert Scott Med. Practice CRS
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
East Bay AIDS Ctr. CRS
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Dr. Shawn Hassler Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Dr. Virginia Cafaro Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94114-1010
Country
United States
Facility Name
Dr. William Owen Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94114-1010
Country
United States
Facility Name
Castro-Mission Health Ctr. CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
St. Mary's Med. Ctr. of San Francisco CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
San Francisco VAMC, Infectious Diseases Clinic CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF PHP, Gen. Internal Medicine Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Beacon Clinic at Boulder CRS
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80501-4507
Country
United States
Facility Name
Denver Infectious Diseases Consultants CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Kaiser Permanente of Denver CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Univ. of Colorado Health Science Ctr. CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Denver Public Health CRS - INSIGHT
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Denver Public Health CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Eastside Family Health Ctr. CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
APEX Family Medicine CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Western Infectious Disease Consultants CRS
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown Wellness Clinic
City
Georgetown
State/Province
Delaware
ZIP/Postal Code
19947
Country
United States
Facility Name
Christiana Care Health Services HIV Program CRS
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Klein & Slotten Medical Associates CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Univ. of Illinois Family Ctr. for Infectious Disease CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Lakeshore Infectious Disease Associates CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
North Side Family Medicine CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70805
Country
United States
Facility Name
James Osterberger, MD (Private Med. Practice) CRS
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4390
Country
United States
Facility Name
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New Orleans VAMC CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70146
Country
United States
Facility Name
CRI-Boston CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
CRI-Springfield CRS
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Harper Hosp., Detroit CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State Univ. CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State Univ. INSIGHT CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp. CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Hosp., Div. of Infectious Disease INSIGHT CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Detroit Community Health Connection, Inc. CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48215
Country
United States
Facility Name
Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS
City
Jackson
State/Province
Michigan
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Michigan State Univ., Infectious Disease Clinic CRS
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cooper Univ. Hosp. CRS
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
ID Care Inc. - Hillsborough CRS
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Jersey Shore Univ. Med. Ctr. CRS
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Raritan Bay Med. Ctr., Perth Amboy Division CRS
City
Perth Amboy
State/Province
New Jersey
ZIP/Postal Code
08861
Country
United States
Facility Name
ID Care - Randolph CRS
City
Randolph
State/Province
New Jersey
ZIP/Postal Code
07869
Country
United States
Facility Name
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Facility Name
The Early Intervention Program at Kennedy Hosp. CRS
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
City
Bronx
State/Province
New York
ZIP/Postal Code
10452
Country
United States
Facility Name
Bronx-Lebanon Hosp. Ctr. CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Med. Ctr., AIDS Ctr. CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
St. Vincent Hosp. & Med. Ctr. CRS
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
City
New York
State/Province
New York
ZIP/Postal Code
10037-1802
Country
United States
Facility Name
Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Multnomah County Health Dept., HIV Health Services Ctr. CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97204
Country
United States
Facility Name
Legacy Clinic Good Samaritan CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Research & Education Group-Portland CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Immune Deficiency Clinic of Portland CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Legacy Clinic Emanuel CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Legacy Clinic Northeast CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Temple Univ. School of Medicine CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Baylor College of Medicine, Thomas St. Clinic CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston AIDS Research Team CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey VAMC CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Thomas Street Clinic CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MediCorp, Infectious Disease Associates CRS
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Petersburg Health Care Alliance CRS
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23803
Country
United States
Facility Name
Vernon Harris East End Community Health Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23223
Country
United States
Facility Name
CrossOver Health Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23224
Country
United States
Facility Name
South Richmond Health Care Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23224
Country
United States
Facility Name
Hunter Holmes McGuire VAMC CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
VCU Health Systems, Infectious Disease Clinic CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth Univ. Medical Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15043202
Citation
Anastassopoulou CG, Kostrikis LG. The impact of human allelic variation on HIV-1 disease. Curr HIV Res. 2003 Apr;1(2):185-203. doi: 10.2174/1570162033485311.
Results Reference
background
PubMed Identifier
15167933
Citation
O'Brien SJ, Nelson GW. Human genes that limit AIDS. Nat Genet. 2004 Jun;36(6):565-74. doi: 10.1038/ng1369.
Results Reference
background
PubMed Identifier
15228901
Citation
Telenti A. The genetic cohorts: facing the new challenges in infectious diseases. The HIV model. Enferm Infecc Microbiol Clin. 2004 Jun-Jul;22(6):337-41. doi: 10.1016/s0213-005x(04)73106-7.
Results Reference
background

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Collection of Blood Samples From HIV Infected People

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