Status:
COMPLETED
Observational Study of Treated and Untreated Acute and Early HIV-1 Infection
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
Aaron Diamond AIDS Research Center
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Brief Summary
Group A: Long-term follow-up is needed for subjects identified as acute or early in the course of HIV-1 infection, independent of decisions regarding therapy with highly active anti-retroviral therapy...
Detailed Description
At the initial visit: subjects will undergo a complete history and physical examination. They will have blood drawn for HIV-1 antibody testing, resistance testing, and lymphocyte subsets. In addition,...
Eligibility Criteria
Inclusion
- Group A: HIV-1 infected individuals at least 16 years of age with HIV-1 RNA detectable in the blood (\>2000 copies/ml) and one of the following:
- a negative test for HIV-1 antibodies
- an indeterminate test for HIV-1 antibodies
- a positive test for HIV-1 antibodies with an immature Western Blot (less than 5 bands) which subsequently matures (addition of 2 or more bands)
- a positive test for HIV-1 antibodies and a documented negative test within 6 months of presentation
- a positive test for HIV-1 antibodies with a simultaneous negative low sensitivity ("detuned") assay (S/C \<15)
- Individuals must be able and willing to provide written informed consent
- Group B: Approximately 90 individuals diagnosed with acute HIV-1 infection in the past who have been participating in an ADARC/Rockefeller University Hospital protocol involving treatment of acute HIV-1 infection and are currently on that regimen with HIV-1 RNA consistently less than 50 copies/ml and are interested in changing to a protease inhibitor-sparing regimen or may continue to be treated with medications provided or taken as part of a completed ADARC/RUH study of the treatment of acute and early HIV infection
Exclusion
- Individuals less than 16 years of age
- Individuals who are unable or unwilling to provide written informed consent
Key Trial Info
Start Date :
February 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00219934
Start Date
February 1 2002
End Date
November 1 2010
Last Update
February 17 2012
Active Locations (1)
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1
Rockefeller University Hospital
New York, New York, United States, 10065