Observational Study of Treated and Untreated Acute and Early HIV-1 Infection

Completed

Conditions studied: HIV Infections

In brief

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 (HAART). Group B: This protocol will also be offered to subjects who were diagnosed with acute HIV-1 infection in the past and have been participating in an ADARC/Rockefeller University Hospital treatment protocol for acute HIV-1 infection, and currently have a viral load consistently less than 50 copies/ml on current treatment (Group B)

Key facts

Study ID

NCT00219934

Run by

Rockefeller University

People needed

399

Starts

2002-02-01

Expected to finish

2010-11-01

Last updated by the study team

2012-02-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Individuals less than 16 years of age
• Individuals who are unable or unwilling to provide written informed consent

Where it is running

• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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