Status:
COMPLETED
A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Medarex
Conditions:
Human Immunodeficiency Virus (HIV)
Eligibility:
MALE
18+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 21 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03407105
Start Date
April 21 2003
End Date
February 21 2006
Last Update
January 23 2018
Active Locations (5)
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1
Tower ID Medical Associates
Los Angeles, California, United States, 90048
2
Quest Clinical Research
San Francisco, California, United States, 94115
3
Care Resource
Miami, Florida, United States, 33137
4
Orlando Immunology Center
Orlando, Florida, United States, 32803