- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366026
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study (RAISE)
February 22, 2016 updated by: Immune Response BioPharma, Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92101
- Clinical Site TBA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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).
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REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Other Names:
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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).
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REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Time Frame: 52 Weeks
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The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
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52 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
52 Weeks
|
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
|
52 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Richard Bartholomew, PhD, Immune Response BioPharma, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2017
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
February 6, 2015
First Submitted That Met QC Criteria
February 11, 2015
First Posted (Estimate)
February 19, 2015
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- IR103-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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