REMUNE/IR-HIV-007
Status:Planned
Phase:II
Principal Investigator(s):Richard M Bartholomew, PhD
Objective:The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.
Last updated 2/23/2021
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionExperimental: REMUNE
Remune vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 10 μg of p24 antigen in approximately 100 μg of total protein.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT02291809
Trial Sponsors:
Immune Response BioPharma
Start Date
End Date
November 1, 2017
November 1, 2019
Enrollment:26
Age range:
3 Months ↔
16 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV