Trial · NCT03041012
Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART
NCT03041012, Phase 2, Completed, Aarhus University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART. Trials, record NCT03041012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03041012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART
- NCT number
- NCT03041012
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Aarhus University Hospital
- Conditions
- Hiv
- Interventions
- Romidepsin, 3BNC117, Antiretrovirals
- First posted
- 2017-02-02
- Last updated
- 2025-04-18
- Other registries' IDs
- eudract:2015-002234-53
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma HIV RNA kinetics | 3 months | Time to undetectable (\<20 c/mL) |
| Primary | Quantification of the size of the proviral HIV reservoir | 1 year | Copies of total HIV-1 DNA per 10⁶ CD4+ T cells as measured by digital droplet PCR |
| Primary | Time to viral rebound during ATI | 12 weeks | Days from stopping ART to plasma HIV RNA \>5,000 on two consecutive measurements |
| Secondary | Incidence of treatment emerging events (Safety and tolerability) | 1 year | 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). |
| Secondary | Quantification of the intact proviral DNA | 1 year | Intact HIV-1 DNA in CD4+ T cells (copies per million cells) as measured by dd-PCR. |
| Secondary | Quantification of HIV mRNA and/or p24 positive cells | 30 days from study entry | Frequency of mRNA/p24 postive per 1 million CD4+ T cells by FISH-flow |
| Secondary | Immune reconstitution | 1 year | Absolute CD4+ and CD8+ T cell count |
| Secondary | Analytic treatment interruption (ATI) study | 64 weeks | Time to first plasma HIV RNA \>5000 c/mL |
| Secondary | Impact of pre-ART virus sensitivity to 3BNC117 on ATI outcomes | Baseline and at viral rebound | 3BNC117 sensitivity determined by PhenoSense and/or HIV env sequencing |
| Secondary | T cell mediated HIV specific immunity | First of 365 days | T cell immunity as determined by the HIV AIM assay |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36253609 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03041012
GET https://conductscience.org/api/trials/v1/NCT03041012/registered