Tebas 066290 – Protocol 802456

Principal Investigator(s):Pablo Tebas, MD - University of Pennsylvania
Objective:The study is intended for individuals who are doing well on HAART therapy. In Step 1 of the trial, individuals will be given up to 6 infusions of the study drug VRX496 to see the effect on viral load and CD4 counts. If individuals have no serious adverse effects from the infusions of VRX496 and the viral load and CD4 counts remain stable, they may go on to Step 2 of the study. In Step 2, individuals will stop taking their HAART medication and their viral load, CD4 counts and the number of VRX496 in T cells will be monitored.
Prevention Option(s):Therapeutic Vaccines
Study Design:Open label, Randomized, Uncontrolled
Arms and Assigned Interventions
DescriptionGenetic: VRX496 HIV-based lentiviral vector containing an anti-HIV antisense sequence targeted to the HIV envelope (env) coding sequence. Followed 6 months for five years after 1st infusion VRX496 T cell at 5 years: 1) Not in the blood - contacted yearly for 10 years. 2) Found in the blood - continue f/u once a year until the VRX496 T cells are no longer found in the blood for a maximum of 15 years.
Mode of Delivery
Official Code: NCT00295477
Trial Sponsors: NIAID, University of Pennsylvania
Start Date
End Date
January 31, 2006
Age range: 18 Years ↔ any
Population:Cisgender Men, Cisgender Women, People Living with HIV