An Observational Study of People Who Have Recently Been Infected With HIV
NCT ID: NCT00103961
Last Updated: 2018-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2004-01-31
2014-12-31
Brief Summary
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Study hypothesis: This study will examine the immunological responses that occur early in the course of HIV infection in treated and untreated individuals. The long-term follow-up of these subjects will help identify host immunological and genetic factors along with therapeutic strategies associated with control of viremia and delayed disease progression. In addition, this cohort will provide the recruiting mechanism to support future trials of therapy to restore immune function. Furthermore, this cohort will provide a population suitable to monitoring changing patterns in the transmission of drug resistant viral strains while also evaluating ongoing behavioral risk factors associated with HIV transmission.
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Detailed Description
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Participants in this study will be followed for up to 10 years. During the first year of participation, study visits will occur approximately every 4 weeks for the first 12 weeks, then every 12 weeks thereafter, with a minimum of 8 study visits during the first year. Participants will be asked to complete a behavioral questionnaire at Week 8. After the first year of participation, there will be 4 visits per year. Blood collection and vital sign measurement will occur at each study visit.
Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP CORE01 study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Treatment-naive and treatment-experienced HIV-infected adults
Questionnaire
A behavioral questionnaire will occur at Week 8
Interventions
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Questionnaire
A behavioral questionnaire will occur at Week 8
Eligibility Criteria
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Inclusion Criteria
* Willing to be followed longitudinally by this study
18 Years
64 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Partners Healthcare
Principal Investigators
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Eric Rosenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Partners Healthcare, Massachusetts General Hospital
Bruce D. Walker, MD
Role: PRINCIPAL_INVESTIGATOR
Partners Healthcare, Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Countries
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Related Links
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Click here for more information on AIEDRP CORE01
Other Identifiers
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