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

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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

The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010
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
5
sites
San Francisco, California 94115
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4101 Greenbriar Drive
Houston, Texas 77098
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Houston, TX
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8635 West 3rd Street
Los Angeles, California 90048
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Miami, Florida 33137
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Miami, FL
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Orlando, FL
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