HIV InfectionsNCT00086372
Long-term Follow-up of HIV Infected Patients Identified During Early Infection
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in 5 countries.
Trial summary
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 157 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Jul 2003to Apr 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented acute or recent HIV infection
- Willing to allow study investigators access to and use of participant's medical information from other AIEDRP clinical trials
- Parent or guardian willing to provide informed consent, if applicable
- If enrolled at an AIDS Clinical Trial Group (ACTG) site, must also be participating in one of the following clinical trials: AIN501/ACTG A5216, AIN503/ACTG A5217, or AIN504/ACTG A5218
Who cannot join
- More than 7 days of antiretroviral therapy prior to study entry without adequate documentation of pretreatment viral load and CD4 count. Individuals who have failed postexposure prophylaxis with antiretroviral treatment are not excluded from enrollment.
- Any factor that, in the opinion of the study official, may interfere with study participation
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States22 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Fenway Community Health
Boston, Massachusetts, 02115
State University of NY Downstate
Brooklyn, New York, 11203
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599-7215
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Duke University
Durham, North Carolina, 27701
Cedars-Sinai
Los Angeles, California, 90048
Vanderbilt University
Nashville, Tennessee, 37212
Beth Israel Medical Center
New York, New York, 10003
Aaron Diamond AIDS Research Center
New York, New York, 10016
Columbia University
New York, New York, 10027
Presbyterian Medical Center - Univ. of PA
Philadelphia, Pennsylvania, 19104
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
Community Health Network, Inc.
Rochester, New York, 14642-0001
University of Rochester Medical Center
Rochester, New York, 14642-0001
University of California, San Diego
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94143
Community Research Initiative of New England-Sprin
Springfield, Massachusetts, 01107
Washington University (St. Louis)
St Louis, Missouri, 63108-2138
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Australia4 sites
Carlton Clinic
Carlton VID, 3053
University of New South Wales
Darlinghurst, New South Wales, 2010
Prahran Market Clinic
St Kilda, Victoria, 3182
The Centre Clinic
St Kilda, Victoria, 3182
Canada2 sites
Montreal Chest Institute of the McGill University
Montreal, Quebec, H2W 1T7
University of British Columbia, Vancouver, BC
Vancouver, British Columbia, V6Z 2C7
Brazil1 site
Centro de Referencia Estadual de AIDS (CREAIDS)
Salvador, Estado de Bahia, 40110-160
About this study
Official title: Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP).
Read the detailed description
AIEDRP was established to develop and evaluate data from studies of patients with acute or recent HIV infection. Long-term effects of antiretroviral therapies raise questions regarding the value and necessity of therapeutic interventions during acute and early HIV infection. Conventional randomized clinical trials are generally designed with finite endpoints; most patients who reach an endpoint or complete a protocol are no longer followed. As a result, long-term virologic, immunologic, and clinical outcome data are not available. This is particularly true for participants who fail therapy, require changes in treatment, or develop a treatment-limiting toxicity in a time-limited study.
This database study will establish a cohort of HIV infected individuals who are participating in HIV studies at AIEDRP sites and of HIV infected individuals who have chosen to defer therapy but agree to be followed by this study. The study will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of AIEDRP studies by developing data collection guidelines, defining common research goals, and creating data templates. The primary aim is to determine the long-term virologic, immunologic, and clinical outcomes and complications for patients who were diagnosed during acute or early HIV infection.
Participants in this study will be followed for at least 5 years. Study visits will occur at Weeks 2, 4, and 12, and then every 12 weeks thereafter, through Week 96. After 2 years, study visits will occur every 24 weeks until the end of the study. Participants who start antiretroviral therapy at or after Week 2 will restart the study visit schedule. Study visits will include a medical interview, adherence questionnaire, and blood tests. Duplicate tests performed as part of another study will not be performed if the results of those tests are available.
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Experienced, Treatment Naive
- 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 posted1 Jul 2004 (estimated)
- Study startJul 2003
- Study completionApr 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
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Acute Infection and Early Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Martin Markowitz, MD, Study chair, Aaron Diamond AIDS Research Center, Rockefeller UniversitySusan Little, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086372
- Sponsor's protocol ID
- AIEDRP CORE01
- Other IDs
- ACTG A5228
- Status last verified
- Oct 2012
- First submitted
- 30 Jun 2004
- Last updated
- 29 Oct 2012
- Results posted
- No
Publications
Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.
PubMed 15156484Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
PubMed 15057296Falster K, Gelgor L, Shaik A, Zablotska I, Prestage G, Grierson J, Thorpe R, Pitts M, Anderson J, Chuah J, Mulhall B, Petoumenos K, Kelleher A, Law M. Trends in antiretroviral treatment use and treatment response in three Australian states in the first decade of combination antiretroviral treatment. Sex Health. 2008 Jun;5(2):141-54. doi: 10.1071/sh07082.
PubMed 18588779
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute HIV Infection and Early Disease Research Program (AIEDRP) CORE01 Database
- ClinicalTrials.gov ID
- NCT00086372
- Acronym / sponsor ID
- AIEDRP CORE01
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Acute Infection and Early Disease Research Program
- Study start
- Jul 2003
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Jul 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.
This is a long-term follow-up study of people who are identified during acute or recent HIV infection and are being followed at clinical research sites associated with the Acute HIV Infection and Early Disease Research Program (AIEDRP).
Detailed description
AIEDRP was established to develop and evaluate data from studies of patients with acute or recent HIV infection. Long-term effects of antiretroviral therapies raise questions regarding the value and necessity of therapeutic interventions during acute and early HIV infection. Conventional randomized clinical trials are generally designed with finite endpoints; most patients who reach an endpoint or complete a protocol are no longer followed. As a result, long-term virologic, immunologic, and clinical outcome data are not available. This is particularly true for participants who fail therapy, require changes in treatment, or develop a treatment-limiting toxicity in a time-limited study.
This database study will establish a cohort of HIV infected individuals who are participating in HIV studies at AIEDRP sites and of HIV infected individuals who have chosen to defer therapy but agree to be followed by this study. The study will facilitate longitudinal and prospectively planned meta-analyses or cross-protocol analyses of AIEDRP studies by developing data collection guidelines, defining common research goals, and creating data templates. The primary aim is to determine the long-term virologic, immunologic, and clinical outcomes and complications for patients who were diagnosed during acute or early HIV infection.
Participants in this study will be followed for at least 5 years. Study visits will occur at Weeks 2, 4, and 12, and then every 12 weeks thereafter, through Week 96. After 2 years, study visits will occur every 24 weeks until the end of the study. Participants who start antiretroviral therapy at or after Week 2 will restart the study visit schedule. Study visits will include a medical interview, adherence questionnaire, and blood tests. Duplicate tests performed as part of another study will not be performed if the results of those tests are available.
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 (4 listed)
- Documented acute or recent HIV infection
- Willing to allow study investigators access to and use of participant's medical information from other AIEDRP clinical trials
- Parent or guardian willing to provide informed consent, if applicable
- If enrolled at an AIDS Clinical Trial Group (ACTG) site, must also be participating in one of the following clinical trials: AIN501/ACTG A5216, AIN503/ACTG A5217, or AIN504/ACTG A5218
Key exclusion criteria (2 listed)
- More than 7 days of antiretroviral therapy prior to study entry without adequate documentation of pretreatment viral load and CD4 count. Individuals who have failed postexposure prophylaxis with antiretroviral treatment are not excluded from enrollment.
- Any factor that, in the opinion of the study official, may interfere with study participation
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 29 Oct 2012.
- Background: PubMed 15156484Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. doi: 10.1086/420745. Epub 2004 Apr 30.
- Background: PubMed 15057296Pilcher CD, Eron JJ Jr, Galvin S, Gay C, Cohen MS. Acute HIV revisited: new opportunities for treatment and prevention. J Clin Invest. 2004 Apr;113(7):937-45. doi: 10.1172/JCI21540.
- Results publication: PubMed 18588779Falster K, Gelgor L, Shaik A, Zablotska I, Prestage G, Grierson J, Thorpe R, Pitts M, Anderson J, Chuah J, Mulhall B, Petoumenos K, Kelleher A, Law M. Trends in antiretroviral treatment use and treatment response in three Australian states in the first decade of combination antiretroviral treatment. Sex Health. 2008 Jun;5(2):141-54. doi: 10.1071/sh07082.
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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.
Martin Markowitz, MD study chair
Aaron Diamond AIDS Research Center, Rockefeller University
Susan Little, MD study chair
University of California, San Diego
30 sites in 5 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 30 sites in 5 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 4 inclusion and 2 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 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, Canada, Brazil, Zimbabwe. 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 NCT00086372, 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 29 Oct 2012.