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NCT02291809 Clinical Trial

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

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02291809
Other study ID # IR-HIV-007
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received November 6, 2014
Last updated February 22, 2016
Start date November 2017
Est. completion date November 2019

Study information
Verified date February 2016
Source Immune Response BioPharma, Inc.
Contact Richard M Bartholomew, PhD
Phone (858) 414-4664
Email richardmbartholomew@gmail.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 26
Est. completion date November 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 16 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• REMUNE
Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

Locations
Country Name City State
United States Clinical Site TBA San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Immune Response BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
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