REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

Phase 2

• 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.

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Study Start: 2017-11
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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

Exclusion Criteria

• 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