NCT03407105

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2006

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

January 17, 2018

Last Update Submit

January 17, 2018

Conditions

Human Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (3)

  • Number of treatment induced dose limiting toxicities (DLTs)

    Up to 141 days

  • Grade of treatment induced DLTs

    Up to 141 days

  • Number of treatment emergent AEs (adverse events)

    Up to 141 days

Secondary Outcomes (15)

  • 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

  • CD4 T cell cytokine responses to Candida antigen

    Up to 141 days

  • +10 more secondary outcomes

Study Arms (1)

Arm 2

EXPERIMENTAL

Specified dose on specified days

Biological: MDX-010

Interventions

MDX-010BIOLOGICAL

Specified dose on specified days

Also known as: Ipilimumab, BMS-734016
Arm 2

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tower ID Medical Associates

Los Angeles, California, 90048, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Care Resource

Miami, Florida, 33137, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Shannon Schrader, MD

Houston, Texas, 77098, United States

Location

Related Publications (1)

  • 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.

    PMID: 29879143DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 23, 2018

Study Start

April 21, 2003

Primary Completion

February 21, 2006

Study Completion

February 21, 2006

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(5)