Status:
WITHDRAWN
Raltegravir Activity In Lymphoid Tissues
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The reduction with antiretroviral therapy (ART) of HIV RNA in blood, and HIV RNA in infected cells and in viruses associated with the follicular dendritic cell (FDC) network in lymphatic tissues, typi...
Detailed Description
The study will evaluate rates of HIV elimination in peripheral blood in comparison to secondary lymphatic tissues, including inguinal lymph nodes (LN) and gastrointestinal lymphatic tissues (GALT). HI...
Eligibility Criteria
Inclusion
- HIV positive (proven serologically at the time of screen, unless evidence for seroconversion)
- Evidence of recent (proven seroconversion within 4 months) or acute infection (HIV antibody negative, HIV RNA positive), or CD4 T Cells \> 350 in peripheral blood and plasma viral load \> 100,000 copies/ml
- Antiretroviral therapy naive (no prior history of antiretroviral therapy)
- Negative pregnancy test for eligible women of childbearing potential
Exclusion
- Contraindication to surgical and endoscopic procedures (as judged by the principal investigator)
- Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
- Pregnancy
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00863668
Start Date
March 1 2009
End Date
March 1 2011
Last Update
May 18 2015
Active Locations (1)
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1
University of Minnesota Medical Center, Division of Infectious Diseases
Minneapolis, Minnesota, United States, 55455