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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IR103 REMUNE + AMPLIVAX 1.0 | Experimental | 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). |
|
| AMPLIVAX 1.0 + IFA | Placebo Comparator | AMPLIVAX 1.0 mg Amplivaxâ„¢ (HYB2055) Adjuvant (1.0 mg) + IFA Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IR103 | Biological | REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Bartholomew, PhD. | Contact | 858-414-4664 | RichardmBartholomew@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard Bartholomew, PhD | Immune Response BioPharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site TBA | San Diego | California | 92101 | United States |
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| ID | Term |
|---|---|
| C587694 | IMO-2055 |
| C105086 | remune |
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The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups at Week 52 |
| 52 Weeks |