REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
- Conditions
- HIV/AIDS
- Interventions
- Biological: REMUNE
- 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
- Arm && Interventions
Group Intervention Description REMUNE Low Dose REMUNE Remune low dose 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 2.5 μg of p24 antigen in approximately 25 μg of total protein. REMUNE 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.
- 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