REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
- Conditions
- HIV/AIDS
- Registration Number
- NCT02291809
- Lead Sponsor
- Immune Response BioPharma, Inc.
- Brief Summary
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.
- Detailed Description
This is a 26 subject Multi Center double-blind randomized, Safety \& Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ \& CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection \& immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
- Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
- Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs
- Truvada
- Triple cocktail HAART drugs
- Healthy subjects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 52 Weeks The primary objective is to compare \& evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52 52 Weeks The primary objective is to compare \& evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
- Secondary Outcome Measures
Name Time Method The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE 52 Weeks The secondary objective is to evaluate \& compare between the treatment groups the ability to induce immune responses between the adult and low doses of REMUNE
The secondary objective is to evaluate & compare the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection 52 Weeks HIV-1 immunogen on viral replication in children with HIV-1 infection
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups 52 The secondary objective is to evaluate \& compare changes in CD4+ \& CD8+ T cell counts between the treatment groups
Trial Locations
- Locations (1)
Clinical Site TBA
🇺🇸San Diego, California, United States
Clinical Site TBA🇺🇸San Diego, California, United StatesRichard M Bartholomew, PhDContact858-414-4664richardmbartholomew@gmail.com