REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
NCT ID: NCT02366026
Last Updated: 2016-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2017-06-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
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).
IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Interventions
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IR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are at least 16 years old (consent of parent or guardian required if under 18 years).
Exclusion Criteria
* Currently abuse alcohol or drugs.
16 Years
ALL
No
Sponsors
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Immune Response BioPharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Bartholomew, PhD
Role: STUDY_DIRECTOR
Immune Response BioPharma, Inc.
Locations
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Clinical Site TBA
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Immune Response BioPharma, Inc.
Other Identifiers
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IR103-007
Identifier Type: -
Identifier Source: org_study_id
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