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3BNC117 and 10-1074 in HIV-infected Individuals

NCT02825797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-08-21

No results posted yet for this study

Summary

This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.

Conditions

  • Human Immunodeficiency Virus (HIV)

Interventions

DRUG

3BNC117

Intravenous infusion of 3BNC117

DRUG

10-1074

Intravenous infusion of 10-1074

OTHER

Analytical treatment interruption

Analytical treatment interruption

DRUG

Placebo

Intravenous infusion of placebo (sterile saline)

Sponsors & Collaborators

  • University Hospital of Cologne

    collaborator OTHER

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Marina Caskey, MD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-08-01
Completion
2018-08-15
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT02825797 on ClinicalTrials.gov