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

Last updated: February 22, 2016
Sponsor: Immune Response BioPharma, Inc.
Overall Status: Trial Status Unknown

Phase

3

Condition

Hiv

Treatment

N/A

Clinical Study ID

NCT02366026
IR103-007
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are HIV-positive and started anti-HIV drugs soon after tests showed the presence ofHIV.

  • Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion

Exclusion Criteria:

  • Healthy Subjects

  • Currently abuse alcohol or drugs.

Study Design

Total Participants: 500
Study Start date:
June 01, 2017
Estimated Completion Date:
June 30, 2019

Study 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.

Connect with a study center

  • Clinical Site TBA

    San Diego, California 92101
    United States

    Site Not Available

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