Overview

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

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
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 (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)
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rockefeller University
Collaborator:
Aaron Diamond AIDS Research Center
Treatments:
Anti-Retroviral Agents
Criteria
Inclusion Criteria:

- 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:

1. a negative test for HIV-1 antibodies

2. an indeterminate test for HIV-1 antibodies

3. 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)

4. a positive test for HIV-1 antibodies and a documented negative test within 6
months of presentation

5. a positive test for HIV-1 antibodies with a simultaneous negative low sensitivity
("detuned") assay (S/C <15)

6. 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 Criteria:

- Individuals less than 16 years of age

- Individuals who are unable or unwilling to provide written informed consent