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Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART

NCT03041012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-18

No results posted yet for this study

Summary

To evaluate the effect of early viral reactivation by latency reversing agents (LRA) and/or administration of potent broadly neutralizing antibodies (bNAb) on the size of the latent HIV-1 reservoir in treatment naïve HIV-1 patients initiating antiretroviral therapy (ART)

Conditions

Interventions

DRUG

Romidepsin

5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART

DRUG

3BNC117

30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART

DRUG

Antiretrovirals

Combination antiretroviral therapy

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Herning Hospital

    collaborator OTHER

  • Hammersmith Hospitals NHS Trust

    collaborator OTHER

  • St Mary's Hospital, London

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Ole S Søgaard, MD PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2021-08-20
Completion
2022-12-30

Countries

  • Denmark
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03041012 on ClinicalTrials.gov