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

Phase 3

• Conditions: HIV
• Interventions: Biological: IR103

• Registration Number: NCT02366026
• Lead Sponsor: Immune Response BioPharma, Inc.

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Study Start: 2017-06
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
• Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion Criteria

• Healthy Subjects
• Currently abuse alcohol or drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IR103 REMUNE + AMPLIVAX 1.0	IR103	IR103 Vaccine contain the same active component as REMUNE® (Inactivated HIV-1 Antigen Drug Substance at 10 μg/mL p24 dose), and have one dose of Amplivax™ (HYB2055) Adjuvant (1.0 mg) added before emulsification in Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).
AMPLIVAX 1.0 + IFA	IR103	AMPLIVAX 1.0 mg Amplivax™ (HYB2055) Adjuvant (1.0 mg) + IFA Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).

Primary Outcome Measures

Name	Time	Method
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 at Week 52

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups	52 Weeks	The secondary objective is to evaluate \& compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups	52 Weeks	The secondary objective is to evaluate \& compare changes in CD4+ \& CD8+ T cell counts between the treatment groups at Week 52

Trial Locations

Locations (1)

Clinical Site TBA; 🇺🇸 San Diego, California, United States