Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02366026
Recruitment Status : Not yet recruiting
First Posted : February 19, 2015
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Biological: IR103 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
Study Start Date : June 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: IR103 REMUNE + AMPLIVAX 1.0
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).
Biological: IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Other Names:
  • HIV-1 IMMUNOGEN + Amplivax
  • REMUNE + Amplivax

Placebo Comparator: AMPLIVAX 1.0 + IFA
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).
Biological: IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Other Names:
  • HIV-1 IMMUNOGEN + Amplivax
  • REMUNE + Amplivax




Primary Outcome Measures :
  1. The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 [ Time Frame: 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 :
  1. The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups [ Time Frame: 52 Weeks ]
    The secondary objective is to evaluate & compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52

  2. The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups [ Time Frame: 52 Weeks ]
    The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups at Week 52



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366026


Contacts
Layout table for location contacts
Contact: Richard Bartholomew, PhD. 858-414-4664 RichardmBartholomew@gmail.com

Locations
Layout table for location information
United States, California
Clinical Site TBA Not yet recruiting
San Diego, California, United States, 92101
Contact: Richard Bartholomew, PhD    858-414-4664    RichardmBartholomew@gmail.com   
Sponsors and Collaborators
Immune Response BioPharma, Inc.
Investigators
Layout table for investigator information
Study Director: Richard Bartholomew, PhD Immune Response BioPharma, Inc.

Additional Information:
Layout table for additonal information
Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02366026     History of Changes
Other Study ID Numbers: IR103-007
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Immune Response BioPharma, Inc.:
HIV