A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/25/2018 |
Start Date: | April 21, 2003 |
End Date: | February 21, 2006 |
A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010
in HIV-infected subjects
in HIV-infected subjects
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)
We found this trial at
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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