A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)

Study Overview
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Brief Summary
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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

Official Title
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A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus

Conditions
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Human Immunodeficiency Virus (HIV)

Intervention / Treatment
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* Biological: MDX-010


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL) CD4 count greater than or equal to 100 cells/mm3 Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy No significant organ compromise Exclusion Criteria: Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine History of autoimmune disease at risk for recurrence Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc Currently undergoing treatment or prophylaxis for tuberculosis infection Chronic active infectious disease (other than HIV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 2<br>Specified dose on specified days | Biological: MDX-010<br>* Specified dose on specified days<br>* Other names: BMS-734016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |