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REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study — RAISE  

HIV Clinical Trial

Official title:
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

Clinical Trial Summary

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.

Clinical Trial Description

This is a 500 subject Multi Center double-blind randomized, Safety & Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen & Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection & to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax. ;

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

Clinical Trial Details
NCT number NCT02366026
Study type Interventional
Source Immune Response BioPharma, Inc.
Contact Richard Bartholomew, PhD.
Phone 858-414-4664
Email RichardmBartholomew@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date June 2017
Completion date June 2019
View Details
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