REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a 500 subject Multi Center double-blind randomized, Safety & Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen & Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection & to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.

Official Title
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REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

Conditions
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HIV

Intervention / Treatment
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* Biological: IR103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV. Are at least 16 years old (consent of parent or guardian required if under 18 years). Exclusion Criteria: Healthy Subjects Currently abuse alcohol or drugs.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IR103 REMUNE + AMPLIVAX 1.0<br>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). | Biological: IR103<br>* REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax<br>* Other names: REMUNE + Amplivax;|
| Placebo Comparator: AMPLIVAX 1.0 + IFA<br>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). | Biological: IR103<br>* REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax<br>* Other names: REMUNE + Amplivax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 HIV viral load at Week 52 | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups | The secondary objective is to evaluate & compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52 | 52 Weeks | 
| 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 CD4+ & CD8+ T cell counts between the treatment groups at Week 52 | 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV