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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52
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
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