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NCT02366026 Clinical Trial

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

HIV Clinical Trial

— RAISE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02366026
Other study ID # IR103-007
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received February 6, 2015
Last updated February 22, 2016
Start date June 2017
Est. completion date June 2019

Study information
Verified date February 2016
Source Immune Response BioPharma, Inc.
Contact Richard 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 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

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:
• IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax

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 at Week 52 52 Weeks Yes
Secondary The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups The secondary objective is to evaluate & compare changes in WBC White Blood Cell Counts between the treatment groups 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 at Week 52 52 Weeks Yes
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