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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Biological: REMUNE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMUNE<br>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. | Biological: REMUNE<br>* Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine<br>* Other names: HIV-1 Immunogen;|
| Placebo Comparator: REMUNE Low Dose<br>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. | Biological: REMUNE<br>* Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine<br>* Other names: HIV-1 Immunogen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 | The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) 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 | The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52 | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups | 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 the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection | HIV-1 immunogen on viral replication in children with HIV-1 infection | 52 Weeks | 
| The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE | 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 | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, HIV/AIDS, Pediatric, HIV-1 Immunogen