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Safety and Immune Response of BMS-936559 in HIV-Infected People Taking Combination Antiretroviral Therapy

NCT02028403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-11-05

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

BMS-936559

0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg of BMS-936559, depending on which cohort participants are enrolled in, administered as an intravenous (IV) infusion

DRUG

Placebo for BMS-936559

Sodium chloride for injection 0.9%, USP, administered as an IV infusion

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joseph Eron Jr., MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028403 on ClinicalTrials.gov