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

Phase 1

Completed

• Conditions: Human Immunodeficiency Virus (HIV)
• Interventions: Biological: MDX-010

• Registration Number: NCT03407105
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-04-21
• Primary Completion: 2006-02-21
• Study Completion: 2006-02-21
• Status Verified: 2018-01
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2	MDX-010	Specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Grade of treatment induced DLTs	Up to 141 days
Number of treatment emergent AEs (adverse events)	Up to 141 days
Number of treatment induced dose limiting toxicities (DLTs)	Up to 141 days

Secondary Outcome Measures

Name	Time	Method
Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens	Up to 141 days
LPA to Candida antigens	Up to 141 days
CD4 T cell cytokine responses to Candida antigen	Up to 141 days
CD4 T cell cytokine responses to tetanus antigen	Up to 141 days
CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens	Up to 141 days
CD8 T cell cytokine responses to Candida antigen	Up to 141 days
CD8 T cell cytokine responses to tetanus antigen	Up to 141 days
Maximum plasma concentration observed post-dose (Cmax)	Up to 141 days
Time of maximum plasma concentration observed post-dose (Tmax)	Up to 141 days
HIV Ribonucleic Acid (RNA) level	Up to 141 days
CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens	Up to 141 days
LPA to tetanus antigens	Up to 141 days
Anti-tetanus toxin antibody level	Up to 141 days
Number of CD4 T cells	Up to 141 days
Number of CD8 T cells	Up to 141 days

Trial Locations

Locations (5)

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Tower ID Medical Associates; 🇺🇸 Los Angeles, California, United States

Care Resource; 🇺🇸 Miami, Florida, United States

Shannon Schrader, MD; 🇺🇸 Houston, Texas, United States