HIV InfectionsNCT00377169
Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 42 sites in 16 countries.
Trial summary
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 3,261 participants
- Where
- 42 sitesin 16 countries
- Study dates
- Start not givento Jan 2006
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Coenrollment in the SMART study
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
None listed.
Trial locations and contacts
42 sites in 16 countries.
42 sites in 16 countries
United States17 sites
Absolute Care Clinic
Atlanta, Georgia, 30308
AID Atlanta/Morehouse Medical School Ryan White Cl
Atlanta, Georgia, 30308
AIDS Research Consortium of Atlanta (ARCA) Central
Atlanta, Georgia, 30308
Dr. Dennis Melton (private practice)
Atlanta, Georgia, 30308
Dr. Melanie Thompson and Dr. Annette Bernard (private practice)
Atlanta, Georgia, 30308
Dr. Richard Hudson (private practice)
Atlanta, Georgia, 30308
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Comprehensive Care Center/North Broward Hospital
Fort Lauderdale, Florida, 33311
University of North Texas Health Science Center
Fort Worth, Texas, 76104
AltaMed Health Services Corporation
Los Angeles, California, 90022
Los Angeles Gay & Lesbian Community Service Center
Los Angeles, California, 90028
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
VA Greater Loss Angeles Healthcare System
Los Angeles, California, 90073
Froedtert and Medical College I.D. Clinic
Milwaukee, Wisconsin, 53226
Mayo Clinic/CORNET
Rochester, Minnesota, 55902
Hillsborough County Health Department
Tampa, Florida, 33602
Westchester Medical Center/New York Medical College
Valhalla, New York, 10595
Germany4 sites
University Hospital Koln (Cologne)
Cologne
J.W. Goethe University Hospital
Frankfurt
ifi Institut
Hamburg, D-20099
Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der
Munich
Australia3 sites
Royal Melbourne Hospital
Parkville, Victoria, 3052
Royal Perth Hospital
Perth
Westmead Hospital
Westmead
New Zealand3 sites
Christchurch Hospital
Christchurch
Waikato Hospital
Hamilton
Wellington Hospital
Newtown, Wellington Region
Portugal3 sites
Centro Hospital de Cascais
Cascais, 2750-406 PT
Hospital de Santa Maria
Lisbon, 1649-028 PT
Hospital Joaquim Urbano
Porto, 4369-004 PT
The Gambia2 sites
Medizinische Universitatsklinik
Bonn, 53105
Klinikum der Ruprecht-Karis-Universitat (U. Hospit)
Heidelberg, D-69115
American Samoa1 site
Gladstone Road Medical Centre
Highgate Hill, 4101
Belgium1 site
C.H.U. St. Pierre Center Hospitalier Universitaire
Brussels, 1000
Denmark1 site
Arbus Universitetshospital, Skejby Department of Infectious Diseases
Brendstrupgaardvej Aarhus, DK-8200
About this study
Official title: Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.
Read the detailed description
Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.
This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- 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 posted15 Sep 2006 (estimated)
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3,261 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Community Programs for Clinical Research on AIDS
- Investigators
- Jonathan Uy, MD, Study chair, AIDS Research Alliance Chicago (ARAC), University of Illinois at ChicagoRoberto Arduino, MD, Study chair, The University of Texas Health Science Center, HoustonFraser Drummond, MBChB, MRCA, DA (UK), Study chair, National Centre in HIV Epidemiology and Clinical Research, University of New South WalesDaniela Gey, MD, Study chair, Copenhagen HIV Programme, Hvidovre University HospitalAdrian Palfreeman, MD, Study chair, Peterborough and Stamford Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377169
- Sponsor's protocol ID
- CPCRA 065H
- Other IDs
- SMART
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2006
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
- ClinicalTrials.gov ID
- NCT00377169
- Acronym / sponsor ID
- CPCRA 065H
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,261 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Community Programs for Clinical Research on AIDS
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 15 Sep 2006 (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 SMART study participants to use in future genetic studies.
Detailed description
Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.
This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Coenrollment in the SMART study
- Parent or guardian willing to provide informed consent, if applicable
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 1 Nov 2016.
- Click here for more information on CPCRA 065Link provided by the sponsor.
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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
Roberto Arduino, MD study chair
The University of Texas Health Science Center, Houston
Fraser Drummond, MBChB, MRCA, DA (UK) study chair
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales
42 sites in 16 countries: 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 42 sites in 16 countries.
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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Germany, Australia, New Zealand, Portugal and 11 more countries. 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?
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 1 Nov 2016.