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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.
This is a 26 subject Multi Center double-blind randomized, Safety & Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection & immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMUNE | Experimental | 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. |
|
| REMUNE Low Dose | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMUNE | Biological | Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine |
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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 (HIV RNA Viral Load) at Week 52 | 52 Weeks |
| The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts 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 | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard M Bartholomew, PhD | Contact | (858) 414-4664 | richardmbartholomew@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard M Bartholomew, PhD | Immune Response BioPharma, Inc. Chief R&D Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site TBA | San Diego | California | 92101 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C105086 | remune |
| C098825 | HIV-1 immunogen, incomplete Freund's adjuvant |
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HIV-1 immunogen on viral replication in children with HIV-1 infection |
| 52 Weeks |
| 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 between the treatment groups the ability to induce immune responses between the adult and low doses of REMUNE | 52 Weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |