Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-04 @ 12:30 AM
Study NCT ID:
NCT02028403
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immune Response of BMS-936559 in HIV-Infected People Taking Combination Antiretroviral Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Safety, Pharmacokinetics and Immunotherapeutic Activity of an Anti-PD-L1 Antibody (BMS-936559) in HIV-1 Infected Participants on Suppressive cART: A Phase I, Double-Blind, Placebo-Controlled, Ascending Single Dose Study
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People infected with HIV may have low levels of the virus in their body, even if they are taking HIV medications. This study will evaluate the safety, pharmacokinetics (PK) (which is how the body interacts with drugs), and immune response to BMS-936559, a drug that will be administered by an intravenous (IV) infusion, in HIV-infected people receiving combination antiretroviral therapy (cART) who have viral load levels below the limit of detection.
Detailed Description:
People infected with HIV who are taking cART and have low viral load levels may still have reservoirs of HIV remaining in their body. BMS-936559 is a drug that has been studied in previous clinical trials to treat various types of cancer. The purpose of this study is to evaluate the safety, PK, and immunotherapeutic activity of a single dose of BMS-936559 (administered by an IV infusion) in HIV-infected people who are receiving cART and who have viral loads below the limit of detection. Researchers will also evaluate whether BMS-936559 can reduce hidden reservoirs of HIV.
Participants will be enrolled in four cohorts. Within each cohort, participants will be randomly assigned to receive BMS-936559 (Cohort 1: 0.3 mg/kg; Cohort 2: 1 mg/kg; Cohort 3: 3 mg/kg; or Cohort 4: 10 mg/kg) or placebo. The four cohorts will be enrolled sequentially, with researchers reviewing safety data of the cohort before enrolling participants in the next cohort.
Prior to study entry, all participants must have an eye exam and an electrocardiogram (ECG). At study entry, participants will undergo a medical and medication history review, physical examination, an eye exam, and a blood collection. Some female participants will have a pregnancy test. All participants will then receive a single IV infusion of their assigned dose of BMS-936559 or placebo. The infusion will occur over a period of 60 minutes, and participants will remain in the clinic for observation for an additional 12 hours. Additional study visits will occur at Days 3, 7, 14, 28, and Weeks 10, 16, 24, 36, and 48. These study visits may include a physical examination, blood collection, adherence assessments, and PK evaluations. Some participants may have additional eye exams during the study, on an as-needed basis.
Participants will be enrolled in four cohorts. Within each cohort, participants will be randomly assigned to receive BMS-936559 (Cohort 1: 0.3 mg/kg; Cohort 2: 1 mg/kg; Cohort 3: 3 mg/kg; or Cohort 4: 10 mg/kg) or placebo. The four cohorts will be enrolled sequentially, with researchers reviewing safety data of the cohort before enrolling participants in the next cohort.
Prior to study entry, all participants must have an eye exam and an electrocardiogram (ECG). At study entry, participants will undergo a medical and medication history review, physical examination, an eye exam, and a blood collection. Some female participants will have a pregnancy test. All participants will then receive a single IV infusion of their assigned dose of BMS-936559 or placebo. The infusion will occur over a period of 60 minutes, and participants will remain in the clinic for observation for an additional 12 hours. Additional study visits will occur at Days 3, 7, 14, 28, and Weeks 10, 16, 24, 36, and 48. These study visits may include a physical examination, blood collection, adherence assessments, and PK evaluations. Some participants may have additional eye exams during the study, on an as-needed basis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 11921 | REGISTRY | DAIDS ES | View |