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Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV

NCT03837756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-05-23

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of lefitolimod and 3BNC117/10-1074 in HIV-1-infected individuals on ART and during ATI as intervention to reduce the HIV-1 reservoir

Conditions

Interventions

DRUG

Saline

Placebo

DRUG

Lefitolimod

A TLR9 agonist administered s.c. once weekly for 8 weeks.

DRUG

3BNC117 and 10-1074

Broadly neutralizing antibodies against HIV env administered two times with a 3 week interval.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • The Peter Doherty Institute for Infection and Immunity

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Ole S Søgaard, MD PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2022-07-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • Norway

Study Locations

More Related Trials

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 NCT03837756 on ClinicalTrials.gov