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Cancer Vaccine

REMUNE for HIV/AIDS

Phase 2
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52
Awards & highlights

Study Summary

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Secondary outcome measures
The secondary objective is to evaluate & compare between the treatment groups to induce immune responses between adult and low doses of REMUNE
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 the effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: REMUNEExperimental Treatment1 Intervention
Remune vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 10 μg of p24 antigen in approximately 100 μg of total protein.
Group II: REMUNE Low DosePlacebo Group1 Intervention
Remune low dose vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 2.5 μg of p24 antigen in approximately 25 μg of total protein.

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Who is running the clinical trial?

Immune Response BioPharma, Inc.Lead Sponsor
4 Previous Clinical Trials
862 Total Patients Enrolled
Richard M Bartholomew, PhDStudy DirectorImmune Response BioPharma, Inc. Chief R&D Officer

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 HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
2017. "REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02291809.
All > Aids
~3 spots leftby May 2025
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