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| Name | Class |
|---|---|
| Medarex | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Experimental | Specified dose on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDX-010 | Biological | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment induced dose limiting toxicities (DLTs) | Up to 141 days | |
| Grade of treatment induced DLTs | Up to 141 days | |
| Number of treatment emergent AEs (adverse events) | Up to 141 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration observed post-dose (Cmax) | Up to 141 days | |
| Time of maximum plasma concentration observed post-dose (Tmax) | Up to 141 days | |
| HIV Ribonucleic Acid (RNA) level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower ID Medical Associates | Los Angeles | California | 90048 | United States | ||
| Quest Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29879143 | Derived | Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I. An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients. PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018. |
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| Up to 141 days |
| CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens | Up to 141 days |
| CD4 T cell cytokine responses to Candida antigen | Up to 141 days |
| CD4 T cell cytokine responses to tetanus antigen | Up to 141 days |
| CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens | Up to 141 days |
| CD8 T cell cytokine responses to Candida antigen | Up to 141 days |
| CD8 T cell cytokine responses to tetanus antigen | Up to 141 days |
| Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens | Up to 141 days |
| LPA to Candida antigens | Up to 141 days |
| LPA to tetanus antigens | Up to 141 days |
| Anti-tetanus toxin antibody level | Up to 141 days |
| Number of CD4 T cells | Up to 141 days |
| Number of CD8 T cells | Up to 141 days |
| San Francisco |
| California |
| 94115 |
| United States |
| Care Resource | Miami | Florida | 33137 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Shannon Schrader, MD | Houston | Texas | 77098 | United States |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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