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

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ClinicalTrials.gov Identifier: NCT03407105
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Biological: MDX-010 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
Actual Study Start Date : April 21, 2003
Actual Primary Completion Date : February 21, 2006
Actual Study Completion Date : February 21, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Arm 2
Specified dose on specified days
Biological: MDX-010
Specified dose on specified days
Other Names:
  • Ipilimumab
  • BMS-734016




Primary Outcome Measures :
  1. Number of treatment induced dose limiting toxicities (DLTs) [ Time Frame: Up to 141 days ]
  2. Grade of treatment induced DLTs [ Time Frame: Up to 141 days ]
  3. Number of treatment emergent AEs (adverse events) [ Time Frame: Up to 141 days ]

Secondary Outcome Measures :
  1. Maximum plasma concentration observed post-dose (Cmax) [ Time Frame: Up to 141 days ]
  2. Time of maximum plasma concentration observed post-dose (Tmax) [ Time Frame: Up to 141 days ]
  3. HIV Ribonucleic Acid (RNA) level [ Time Frame: Up to 141 days ]
  4. CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens [ Time Frame: Up to 141 days ]
  5. CD4 T cell cytokine responses to Candida antigen [ Time Frame: Up to 141 days ]
  6. CD4 T cell cytokine responses to tetanus antigen [ Time Frame: Up to 141 days ]
  7. CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens [ Time Frame: Up to 141 days ]
  8. CD8 T cell cytokine responses to Candida antigen [ Time Frame: Up to 141 days ]
  9. CD8 T cell cytokine responses to tetanus antigen [ Time Frame: Up to 141 days ]
  10. Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens [ Time Frame: Up to 141 days ]
  11. LPA to Candida antigens [ Time Frame: Up to 141 days ]
  12. LPA to tetanus antigens [ Time Frame: Up to 141 days ]
  13. Anti-tetanus toxin antibody level [ Time Frame: Up to 141 days ]
  14. Number of CD4 T cells [ Time Frame: Up to 141 days ]
  15. Number of CD8 T cells [ Time Frame: Up to 141 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407105


Locations
United States, California
Tower ID Medical Associates
Los Angeles, California, United States, 90048
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
Care Resource
Miami, Florida, United States, 33137
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Texas
Shannon Schrader, MD
Houston, Texas, United States, 77098
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03407105     History of Changes
Other Study ID Numbers: MDX010-10
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases