A Phase 2 interventional study of Romidepsin and 3BNC117 in Hiv, sponsored by Aarhus University Hospital. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Aarhus University Hospital · Phase 2, Interventional, and Treatment
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)
The study will be conducted among ART naïve HIV-1-infected patients.
Subjects will continue ART while receiving LRA romidepsin and/or bNAb 3BNC117.
Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following laboratory values at screening, but the values can be repeated within the screening period, but test results must be available before baseline (day 0) and checked for eligibility:
Use of:
History of:
Standard of care
Drug: Antiretrovirals
Standard of care + LRA
Drug: Romidepsin · Drug: Antiretrovirals
Standard of care + bNAb
Drug: 3BNC117 · Drug: Antiretrovirals
Standard of care + LRA + bNAb
Drug: Romidepsin · Drug: 3BNC117 · Drug: Antiretrovirals
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
Also known as: Istodax
30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Also known as: Broadly neutralizing antibody
Combination antiretroviral therapy
Also known as: ART
Plasma HIV RNA kinetics
Time to undetectable (\<20 c/mL)
Time frame: 3 months
Quantification of the size of the proviral HIV reservoir
Copies of total HIV-1 DNA per 10⁶ CD4+ T cells as measured by digital droplet PCR
Time frame: 1 year
Time to viral rebound during ATI
Days from stopping ART to plasma HIV RNA \>5,000 on two consecutive measurements
Time frame: 12 weeks
Incidence of treatment emerging events (Safety and tolerability)
Frequence and severity of adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reactions (SUSAR).
Time frame: 1 year
Quantification of the intact proviral DNA
Intact HIV-1 DNA in CD4+ T cells (copies per million cells) as measured by dd-PCR.
Time frame: 1 year
Quantification of HIV mRNA and/or p24 positive cells
Frequency of mRNA/p24 postive per 1 million CD4+ T cells by FISH-flow
Time frame: 30 days from study entry
Immune reconstitution
Absolute CD4+ and CD8+ T cell count
Time frame: 1 year
Analytic treatment interruption (ATI) study
Time to first plasma HIV RNA \>5000 c/mL
Time frame: 64 weeks
Impact of pre-ART virus sensitivity to 3BNC117 on ATI outcomes
3BNC117 sensitivity determined by PhenoSense and/or HIV env sequencing
Time frame: Baseline and at viral rebound
T cell mediated HIV specific immunity
T cell immunity as determined by the HIV AIM assay
Time frame: First of 365 days
Plasma cytokine and immune activation biomarker levels
Soluble IL-6, sCD14, sCD163
Time frame: 1 year
Plan to share: Yes — Individual deidentified participant data (including data dictionaries) will be shared following the publication of the primary and secondary endpoints as outlined in this protocol. Data to be shared includes deidentified data points in published, peer-reviewed articles. Additional, related documents will also be available (study protocol, informed consent form). Data will become available following publication with no planned end date.
Supporting information: Study protocol, Icf, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital