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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
Pivotal 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.
~59 spots leftby Nov 2025
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