ISS T-003
Status:Completed
Phase:II
Principal Investigator(s):Maphoshane MN Nchabeleng, MD; Barbara BE Ensoli, MD
Objective:Previous studies in natural HIV infection, indicated that the presence of a Tat-specific immune response correlates with a lower incidence and reduced risk of progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune response to Tat may exert a protective role and control the progression to AIDS in vivo.
Prevention Option(s):Therapeutic Vaccines
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionRecombinant biologically active Tat 30 mcg in Phosphate saline buffer, pH 7.4, 1% sucrose, 1% Human Serum Albumin, administered 3 times at weeks 0, 4 & 8.
Mode of DeliveryIntradermal
ARMsExperimental
Official Code:
NCT01513135
Trial Sponsors:
Istituto Superiore di Sanita, Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
Start Date
End Date
January 31, 2012
none
Enrollment:200
Age range:
18 Years ↔
45 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV