CompletedNCT03407105Updated Jan 23, 2018

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

A Phase 1 interventional study of MDX-010 in Human Immunodeficiency Virus (HIV), sponsored by Bristol-Myers Squibb. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 18 Years and older
Sex: Male

Study 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

Conditions studied

Human Immunodeficiency Virus (HIV)

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

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

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)

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
Arm 2
Specified dose on specified days
Biological: MDX-010

Interventions

BiologicalMDX-010
Specified dose on specified days
Also known as: Ipilimumab, BMS-734016

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

5 sites

Tower ID Medical Associates
Los Angeles, California 90048, United States
Quest Clinical Research
San Francisco, California 94115, United States
Care Resource
Miami, Florida 33137, United States
Orlando Immunology Center
Orlando, Florida 32803, United States
Shannon Schrader, MD
Houston, Texas 77098, United States

References and documents

Publications

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. PubMed 29879143 ↗

Registry details

Key details

Study ID: NCT03407105
Lead sponsor: Bristol-Myers Squibb
Collaborators: Medarex
Responsible party: Sponsor
First posted: Jan 23, 2018
Start date: Apr 21, 2003
Primary completion: Feb 21, 2006
Completion: Feb 21, 2006
Last update: Jan 23, 2018

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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