Human Immunodeficiency Virus (HIV)
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects
Interventions
BIOLOGICALMDX-010
Specified dose on specified days
Sponsors
Medarex
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Maximum plasma concentration observed post-dose (Cmax) | 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 |
| Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens | 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 |
Countries
United States
Outcome results
None listed