A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
Primary Purpose
Human Immunodeficiency Virus (HIV)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX-010
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus (HIV)
Eligibility 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)
Sites / Locations
- Tower ID Medical Associates
- Quest Clinical Research
- Care Resource
- Orlando Immunology Center
- Shannon Schrader, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 2
Arm Description
Specified dose on specified days
Outcomes
Primary Outcome Measures
Number of treatment induced dose limiting toxicities (DLTs)
Grade of treatment induced DLTs
Number of treatment emergent AEs (adverse events)
Secondary Outcome Measures
Maximum plasma concentration observed post-dose (Cmax)
Time of maximum plasma concentration observed post-dose (Tmax)
HIV Ribonucleic Acid (RNA) level
CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens
CD4 T cell cytokine responses to Candida antigen
CD4 T cell cytokine responses to tetanus antigen
CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens
CD8 T cell cytokine responses to Candida antigen
CD8 T cell cytokine responses to tetanus antigen
Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens
LPA to Candida antigens
LPA to tetanus antigens
Anti-tetanus toxin antibody level
Number of CD4 T cells
Number of CD8 T cells
Full Information
NCT ID
NCT03407105
First Posted
January 17, 2018
Last Updated
January 17, 2018
Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
1. Study Identification
Unique Protocol Identification Number
NCT03407105
Brief Title
A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
Official Title
A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 21, 2003 (Actual)
Primary Completion Date
February 21, 2006 (Actual)
Study Completion Date
February 21, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
MDX-010
Other Intervention Name(s)
Ipilimumab, BMS-734016
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of treatment induced dose limiting toxicities (DLTs)
Time Frame
Up to 141 days
Title
Grade of treatment induced DLTs
Time Frame
Up to 141 days
Title
Number of treatment emergent AEs (adverse events)
Time Frame
Up to 141 days
Secondary Outcome Measure Information:
Title
Maximum plasma concentration observed post-dose (Cmax)
Time Frame
Up to 141 days
Title
Time of maximum plasma concentration observed post-dose (Tmax)
Time Frame
Up to 141 days
Title
HIV Ribonucleic Acid (RNA) level
Time Frame
Up to 141 days
Title
CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens
Time Frame
Up to 141 days
Title
CD4 T cell cytokine responses to Candida antigen
Time Frame
Up to 141 days
Title
CD4 T cell cytokine responses to tetanus antigen
Time Frame
Up to 141 days
Title
CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens
Time Frame
Up to 141 days
Title
CD8 T cell cytokine responses to Candida antigen
Time Frame
Up to 141 days
Title
CD8 T cell cytokine responses to tetanus antigen
Time Frame
Up to 141 days
Title
Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens
Time Frame
Up to 141 days
Title
LPA to Candida antigens
Time Frame
Up to 141 days
Title
LPA to tetanus antigens
Time Frame
Up to 141 days
Title
Anti-tetanus toxin antibody level
Time Frame
Up to 141 days
Title
Number of CD4 T cells
Time Frame
Up to 141 days
Title
Number of CD8 T cells
Time Frame
Up to 141 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Tower ID Medical Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Care Resource
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Shannon Schrader, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29879143
Citation
Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I. An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients. PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018.
Results Reference
derived
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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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