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Peg-Interferon Alpha 2b Combined With Two Intravenous Broadly HIV-1 Neutralizing Antibodies 3BNC117 and 10-1074 (BEAT-2)

NCT03588715 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-25

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability and innate immune mechanisms activation following administration of the combination of Pegylated Interferon alpha 2b (peg-IFN-α2b) with two broadly neutralizing antibodies (3BNC117 and 10-1074) in the setting of well-controlled HIV infection with antiretroviral treatment and a monitored analytical treatment interruption. The current proposal builds on previous experience using interferon alpha, 3BNC117 and 10-1074 alone in separate clinical trials that included a closely monitored analytical treatment interruption. The hypothesis is that the joint administration of peg-IFN-α2b with 3BNC117 and 10-1074 will be more effective than either intervention separately in suppressing HIV viremia during 8 weeks of analytical treatment interruption (Step 4) and reducing integrated HIV DNA in blood and tissue when measured during an analytical treatment interruption in patients with well-controlled HIV infection.

Conditions

Interventions

DRUG

Pegylated Interferon alpha 2b (peg-IFN-α2b)

Pegylated Interferon alpha 2b (peg-IFN-α2b) will be administered weekly via subcutaneous route.

DRUG

3BNC117 + 10-1074

Broadly Neutralizing Antibodies - Sequential, separate IV infusions of 3NBC117 + 10-1074.

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • Philadelphia Fight

    collaborator OTHER

  • Rockefeller University

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Luis Montaner

    lead OTHER

Principal Investigators

  • Luis J Montaner, DVM, DPhil · The Wistar Institute

  • Pablo Tebas, M.D. · University of Pennsylvania

  • Karam Mounzer, M.D. · Philadelphia Fight

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2021-12-31
Completion
2022-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03588715 on ClinicalTrials.gov