72
Participants
Start Date
March 29, 2021
Primary Completion Date
November 29, 2024
Study Completion Date
November 29, 2024
Solo 0.3 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
Solo 1 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 1.0 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
Solo 3 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 3.0 and 1.0 mg/injection, i.e. 1.2 ml subcutaneous route in right deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1.2 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
Combi 0.3 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid; and combined with DNA-HIV-PT123 HIV-1 at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
Combi 1 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 1.0 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid; and combined with DNA at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
Combi 3 group
"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 3.0 and 1.0 mg/injection, i.e. 1.2 ml subcutaneous route in right deltoid; and combined with DNA at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24~Or, NaCl at 0.9%, i.e 1.2 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
Late boost CD40 alone
CD40.HIVRI.Env at 0.3 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at week LB (late boost)
Late boost CD40 adjuvanted
CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at week LB (late boost)
Hôpital Henri Mondor, Créteil
CIC 1417 - Hôpital Cochin, Paris
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
ANRS, Emerging Infectious Diseases
OTHER_GOV