WU #8829-99
Status:Ongoing
Phase:I
Principal Investigator(s):Naomi Aronson, MD - Walter Reed Army Medical Center
Objective:Find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2) to improve the immune system.
Prevention Option(s):Therapeutic Vaccines
Study Design:Controlled, Non-randomized, Open label
Arms and Assigned Interventions
DescriptionPatients continue HAART and receive low dose IL-2 (~1.2M IU/m2) sq daily x 56 days
Mode of Delivery
ARMs
DescriptionPatients continue HAART and receive an infusion of 5-10 x E9 T cells by IV infusion.
Mode of Delivery
ARMs
DescriptionPatients continue HAART and receive an infusion of 5-10 x E9 T cells by IV infusion.
Mode of Delivery
ARMs
DescriptionPatients continue HAART and receive an infusion of 5-10 E9 T cells by IV infusion and low dose IL-2 (~1.2M IU/m2) sq daily x 56 days.
Mode of Delivery
ARMs
Official Code:
NCT01013415
Trial Sponsors:
University of Pennsylvania
Start Date
End Date
September 30, 2001
June 30, 2016
Enrollment:24
Age range:
↔
any
Population:Cisgender Men, Cisgender Women, People Living with HIV