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Virus Therapy

IR103 REMUNE + AMPLIVAX 1.0 for HIV/AIDS (RAISE Trial)

Phase 3
Waitlist Available
Research Sponsored by Immune Response BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

RAISE Trial 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.

Eligible Conditions
  • HIV/AIDS

RAISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 CD4+ & CD8+ T cell counts between the treatment groups
The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups

RAISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IR103 REMUNE + AMPLIVAX 1.0Experimental Treatment1 Intervention
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).
Group II: AMPLIVAX 1.0 + IFAPlacebo Group1 Intervention
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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Who is running the clinical trial?

Immune Response BioPharma, Inc.Lead Sponsor
4 Previous Clinical Trials
388 Total Patients Enrolled
Richard Bartholomew, PhDStudy DirectorImmune Response BioPharma, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
2017. "REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02366026.
All > Aids
~63 spots leftby May 2025
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