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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Human Immunodeficiency Virus (HIV)

Treatments

Biological: MDX-010

Study type

Interventional

Funder types

Industry

Identifiers

MDX010-10

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)