NCT03041012

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

Early Administration of Latency Reversing Therapy and Broadly Neutralizing Antibodies to Limit the Establishment of the HIV-1 Reservoir During Initiation of Antiretroviral Treatment - a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The study will be conducted among ART naïve HIV-1-infected patients. Subjects will continue ART while receiving LRA romidepsin and/or bNAb 3BNC117.

Conditions

• Hiv

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-20
• Primary completion: 2021-08-20
• Completion: 2022-12-30
• First posted: 2017-02-02
• Last updated: 2025-04-18

Locations

7 sites across 2 countries: Denmark, United Kingdom