HIV/AIDS
Conditions
Keywords
HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen
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.
Interventions
BIOLOGICALREMUNE
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
Sponsors
Immune Response BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Countries
United States
Contacts
Primary ContactRichard M Bartholomew, PhD
Outcome results
None listed