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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.

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
NameTimeMethod
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 5252 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 5252 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
NameTimeMethod
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE52 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 infection52 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 groups52

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 States
Richard M Bartholomew, PhD
Contact
858-414-4664
richardmbartholomew@gmail.com

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