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



Status:Not yet recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 16
Updated:4/21/2016
Start Date:November 2017
End Date:November 2019
Contact:Richard M Bartholomew, PhD
Email:richardmbartholomew@gmail.com
Phone:(858) 414-4664

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria
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.

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.

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
We found this trial at
1
site
Clinical Site TBA
San Diego, California 92101
Phone: 858-414-4664
?
mi
from
San Diego, CA
Click here to add this to my saved trials