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

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407105
• Other study ID #: MDX010-10
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2018
• Last updated: January 17, 2018
• Start date: April 21, 2003
• Est. completion date: February 21, 2006

Study information

• Verified date: January 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 21, 2006
• Est. primary completion date: February 21, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Biological:
• MDX-010
Specified dose on specified days

Locations

Country	Name	City	State
United States	Shannon Schrader, MD	Houston	Texas
United States	Tower ID Medical Associates	Los Angeles	California
United States	Care Resource	Miami	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Quest Clinical Research	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	This trial was conducted by the previous sponsor, Medarex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment induced dose limiting toxicities (DLTs)		Up to 141 days
Primary	Grade of treatment induced DLTs		Up to 141 days
Primary	Number of treatment emergent AEs (adverse events)		Up to 141 days
Secondary	Maximum plasma concentration observed post-dose (Cmax)		Up to 141 days
Secondary	Time of maximum plasma concentration observed post-dose (Tmax)		Up to 141 days
Secondary	HIV Ribonucleic Acid (RNA) level		Up to 141 days
Secondary	CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens		Up to 141 days
Secondary	CD4 T cell cytokine responses to Candida antigen		Up to 141 days
Secondary	CD4 T cell cytokine responses to tetanus antigen		Up to 141 days
Secondary	CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens		Up to 141 days
Secondary	CD8 T cell cytokine responses to Candida antigen		Up to 141 days
Secondary	CD8 T cell cytokine responses to tetanus antigen		Up to 141 days
Secondary	Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens		Up to 141 days
Secondary	LPA to Candida antigens		Up to 141 days
Secondary	LPA to tetanus antigens		Up to 141 days
Secondary	Anti-tetanus toxin antibody level		Up to 141 days
Secondary	Number of CD4 T cells		Up to 141 days
Secondary	Number of CD8 T cells		Up to 141 days

External Links

•   FDA Safety Alerts and Recalls