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

Primary Purpose

HIV

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IR103
Sponsored by
Immune Response BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Site TBA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IR103 REMUNE + AMPLIVAX 1.0

AMPLIVAX 1.0 + IFA

Arm Description

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 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
February 6, 2015
Last Updated
February 22, 2016
Sponsor
Immune Response BioPharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02366026
Brief Title
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
Acronym
RAISE
Official Title
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Response BioPharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IR103 REMUNE + AMPLIVAX 1.0
Arm Type
Experimental
Arm Description
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).
Arm Title
AMPLIVAX 1.0 + IFA
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
IR103
Other Intervention Name(s)
HIV-1 IMMUNOGEN + Amplivax, REMUNE + Amplivax
Intervention Description
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Primary Outcome Measure Information:
Title
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Description
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups
Description
The secondary objective is to evaluate & compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52
Time Frame
52 Weeks
Title
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups
Description
The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups at Week 52
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Bartholomew, PhD.
Phone
858-414-4664
Email
RichardmBartholomew@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bartholomew, PhD
Organizational Affiliation
Immune Response BioPharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site TBA
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Bartholomew, PhD
Phone
858-414-4664
Email
RichardmBartholomew@gmail.com

12. IPD Sharing Statement

Links:
URL
http://www.immuneresponse.net
Description
Immune Response BioPharma, Inc.

Learn more about this trial

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

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