GCHT01
Status:Ongoing
Phase:I
Principal Investigator(s):Margaret A. Fischl, MD
Objective:This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.
Prevention Option(s):Therapeutic Vaccines
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionLower dose HIVAX vaccine. Vaccine 1.0 ml SQ lower dose (10^8 TU)
Weeks 0, 8 and 16
Mode of Delivery
ARMsExperimental
DescriptionHigher dose vaccine. Biological: HIVAX Vaccine 1.0 ml SQ higher dose (10^9 TU)
At weeks 0, 8 and 16
Mode of Delivery
ARMsExperimental
Official Code:
NCT01428596
Trial Sponsors:
GeneCure Biotechnologies
Start Date
End Date
September 30, 2011
none
Enrollment:30
Age range:
18 Years ↔
60 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV