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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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

The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52

Secondary study objectives

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.

Do I qualify?Apply below to find out