Clinical trial NCT03407105: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Medarex
First posted: 2018-01-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Number of treatment induced dose limiting toxicities (DLTs)
timeFrame: Up to 141 days
measure: Grade of treatment induced DLTs
timeFrame: Up to 141 days
measure: Number of treatment emergent AEs (adverse events)
timeFrame: Up to 141 days
Secondary outcomes:
measure: Maximum plasma concentration observed post-dose (Cmax)
timeFrame: Up to 141 days
measure: Time of maximum plasma concentration observed post-dose (Tmax)
timeFrame: Up to 141 days
measure: HIV Ribonucleic Acid (RNA) level
timeFrame: Up to 141 days
measure: CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens
timeFrame: Up to 141 days
measure: CD4 T cell cytokine responses to Candida antigen
timeFrame: Up to 141 days
measure: CD4 T cell cytokine responses to tetanus antigen
timeFrame: Up to 141 days
measure: CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens
timeFrame: Up to 141 days
measure: CD8 T cell cytokine responses to Candida antigen
timeFrame: Up to 141 days
measure: CD8 T cell cytokine responses to tetanus antigen
timeFrame: Up to 141 days
measure: Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens
timeFrame: Up to 141 days
measure: LPA to Candida antigens
timeFrame: Up to 141 days
measure: LPA to tetanus antigens
timeFrame: Up to 141 days
measure: Anti-tetanus toxin antibody level
timeFrame: Up to 141 days
measure: Number of CD4 T cells
timeFrame: Up to 141 days
measure: Number of CD8 T cells
timeFrame: Up to 141 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower ID Medical Associates
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Miami
country: United States
facility: Care Resource
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Houston
country: United States
facility: Shannon Schrader, MD
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.