HIV InfectionsNCT00096772
Collection of Blood Samples From HIV Infected People
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 83 sites in United States.
Trial summary
The purpose of this study is to collect blood samples from HIV infected individuals for use in future genetic studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- How many people
- 2,502 participants
- Where
- 83 sitesUnited States
- Study dates
- Jan 2005to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants will be selected from those who have given informed consent for participation in a qualifying CPCRA clinical trial.
Who may be able to join
- Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial
- Signed informed consent
Who cannot join
None listed.
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, 70805
James Osterberger, MD (Private Med. Practice) CRS
Baton Rouge, Louisiana, 70808-4390
CRI-Boston CRS
Boston, Massachusetts, 02115
Beacon Clinic at Boulder CRS
Boulder, Colorado, 80501-4507
Cooper Hospital/Univ. Med. Ctr., The Cooper Early Intervention Program (EIP) CRS
Camden, New Jersey, 08103
Cooper Univ. Hosp. CRS
Camden, New Jersey, 08103
Klein & Slotten Medical Associates CRS
Chicago, Illinois, 60610
Univ. of Illinois Family Ctr. for Infectious Disease CRS
Chicago, Illinois, 60612
Lakeshore Infectious Disease Associates CRS
Chicago, Illinois, 60657
North Side Family Medicine CRS
Chicago, Illinois, 60657
Denver Infectious Diseases Consultants CRS
Denver, Colorado, 80204-4507
Kaiser Permanente of Denver CRS
Denver, Colorado, 80204-4507
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, 80204-4507
Denver Public Health CRS - INSIGHT
Denver, Colorado, 80204
Denver Public Health CRS
Denver, Colorado, 80204
Eastside Family Health Ctr. CRS
Denver, Colorado, 80205
APEX Family Medicine CRS
Denver, Colorado, 80206
South Denver Infectious Diseases Specialists, Accord Med. Ctr. CRS
Denver, Colorado, 80218
Harper Hosp., Detroit CRS
Detroit, Michigan, 48201
Wayne State Univ. CRS
Detroit, Michigan, 48201
Wayne State Univ. INSIGHT CRS
Detroit, Michigan, 48201
Henry Ford Hosp. CRS
Detroit, Michigan, 48202
Henry Ford Hosp., Div. of Infectious Disease INSIGHT CRS
Detroit, Michigan, 48202
Detroit Community Health Connection, Inc. CRS
Detroit, Michigan, 48215
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, 22401
Georgetown Wellness Clinic
Georgetown, Delaware, 19947
ID Care Inc. - Hillsborough CRS
Hillsborough, New Jersey, 08844
Baylor College of Medicine, Thomas St. Clinic CRS
Houston, Texas, 77030
Houston AIDS Research Team CRS
Houston, Texas, 77030
Michael E. DeBakey VAMC CRS
Houston, Texas, 77030
Thomas Street Clinic CRS
Houston, Texas, 77030
Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS
Jackson, Michigan, 39216-4505
Michigan State Univ., Infectious Disease Clinic CRS
Lansing, Michigan, 48910
Dr. M. Estes Med. Practice CRS
Mill Valley, California, 94941-3013
Jersey Shore Univ. Med. Ctr. CRS
Neptune City, New Jersey, 07754
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
New Haven, Connecticut, 06510
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
New Orleans, Louisiana, 70112
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
New Orleans, Louisiana, 70112
New Orleans VAMC CRS
New Orleans, Louisiana, 70146
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, 10011
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, 10037-1802
Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS
New York, New York, 10037
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
Newark, New Jersey, 07103
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
Newark, New Jersey, 07103
Dr. Robert Scott Med. Practice CRS
Oakland, California, 94609
East Bay AIDS Ctr. CRS
Oakland, California, 94609
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
Paterson, New Jersey, 07503
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, 07503
Raritan Bay Med. Ctr., Perth Amboy Division CRS
Perth Amboy, New Jersey, 08861
Petersburg Health Care Alliance CRS
Petersburg, Virginia, 23803
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, 19140
Multnomah County Health Dept., HIV Health Services Ctr. CRS
Portland, Oregon, 97204
Legacy Clinic Good Samaritan CRS
Portland, Oregon, 97210
The Research & Education Group-Portland CRS
Portland, Oregon, 97210
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
Portland, Oregon, 97213
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, 97227
Legacy Clinic Emanuel CRS
Portland, Oregon, 97227
Legacy Clinic Northeast CRS
Portland, Oregon, 97227
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, 97239
ID Care - Randolph CRS
Randolph Township, New Jersey, 07869
Vernon Harris East End Community Health Ctr. CRS
Richmond, Virginia, 23223
CrossOver Health Ctr. CRS
Richmond, Virginia, 23224
South Richmond Health Care Ctr. CRS
Richmond, Virginia, 23224
Hunter Holmes McGuire VAMC CRS
Richmond, Virginia, 23249
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, 23298
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, 23298
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, 94102
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, 94110
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, 94114-1010
Dr. William Owen Med. Practice CRS
San Francisco, California, 94114-1010
Castro-Mission Health Ctr. CRS
San Francisco, California, 94114
St. Mary's Med. Ctr. of San Francisco CRS
San Francisco, California, 94117
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, 94121
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, 94143
CRI-Springfield CRS
Springfield, Massachusetts, 01107
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
The Bronx, New York, 10452
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, 10457
Montefiore Med. Ctr., AIDS Ctr. CRS
The Bronx, New York, 10457
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
Union, New Jersey, 07083
The Early Intervention Program at Kennedy Hosp. CRS
Voorhees Township, New Jersey, 08043
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, 20422
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, 80033
Christiana Care Health Services HIV Program CRS
Wilmington, Delaware, 19801
About this study
Official title: Collection and Use of Blood For Genetic and Other Related Analyses (The GENOMICS Protocol)
The purpose of this study is to collect blood samples from HIV infected individuals for use in future genetic studies.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- Genetic Testing, Genomics, Human Genetic Factors
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2004 (estimated)
- Study startJan 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,502 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jonathan Uy, MD, Study chair, AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096772
- Sponsor's protocol ID
- CPCRA 066
- Other IDs
- 10052
- Status last verified
- May 2014
- First submitted
- 15 Nov 2004
- Last updated
- 19 May 2014
- Results posted
- No
Publications
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.
PubMed 15043202O'Brien SJ, Nelson GW. Human genes that limit AIDS. Nat Genet. 2004 Jun;36(6):565-74. doi: 10.1038/ng1369.
PubMed 15167933Telenti 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.
PubMed 15228901
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Use of Blood For Genetic and Other Related Analyses (The GENOMICS Protocol)
- ClinicalTrials.gov ID
- NCT00096772
- Acronym / sponsor ID
- CPCRA 066
- Conditions
- HIV Infections
- Keywords
- Genetic Testing, Genomics, Human Genetic Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,502 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be selected from those who have given informed consent for participation in a qualifying CPCRA clinical trial.
Key inclusion criteria (2 listed)
- Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial
- Signed informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Background: PubMed 15043202Anastassopoulou 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.
- Background: PubMed 15167933O'Brien SJ, Nelson GW. Human genes that limit AIDS. Nat Genet. 2004 Jun;36(6):565-74. doi: 10.1038/ng1369.
- Background: PubMed 15228901Telenti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Uy, MD study chair
AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 83 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.