Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART (eCLEAR)
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ClinicalTrials.gov Identifier: NCT03041012 |
Recruitment Status :
Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : September 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hiv | Drug: Romidepsin Drug: 3BNC117 Drug: Antiretrovirals | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 20, 2017 |
Actual Primary Completion Date : | August 20, 2021 |
Estimated Study Completion Date : | December 30, 2021 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: antiretrovirals
Standard of care
|
Drug: Antiretrovirals
Combination antiretroviral therapy
Other Name: ART |
Active Comparator: antiretrovirals + romidepsin
Standard of care + LRA
|
Drug: Romidepsin
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
Other Name: Istodax Drug: Antiretrovirals Combination antiretroviral therapy
Other Name: ART |
Active Comparator: antiretrovirals + 3BNC117
Standard of care + bNAb
|
Drug: 3BNC117
30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Other Name: Broadly neutralizing antibody Drug: Antiretrovirals Combination antiretroviral therapy
Other Name: ART |
Active Comparator: antiretrovirals + romidepsin + 3BNC117
Standard of care + LRA + bNAb
|
Drug: Romidepsin
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
Other Name: Istodax Drug: 3BNC117 30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Other Name: Broadly neutralizing antibody Drug: Antiretrovirals Combination antiretroviral therapy
Other Name: ART |
- Plasma HIV RNA kinetics [ Time Frame: 3 months ]Time to undetectable (<20 c/mL)
- Quantification of the size of the proviral HIV reservoir [ Time Frame: 1 year ]Copies of total HIV-1 DNA per 10⁶ CD4+ T cells as measured by digital droplet PCR
- Time to viral rebound during ATI [ Time Frame: 12 weeks ]Days from stopping ART to plasma HIV RNA >5,000 on two consecutive measurements
- Incidence of treatment emerging events (Safety and tolerability) [ Time Frame: 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).
- Quantification of the intact proviral DNA [ Time Frame: 1 year ]Intact HIV-1 DNA in CD4+ T cells (copies per million cells) as measured by dd-PCR.
- Quantification of HIV mRNA and/or p24 positive cells [ Time Frame: 30 days from study entry ]Frequency of mRNA/p24 postive per 1 million CD4+ T cells by FISH-flow
- Immune reconstitution [ Time Frame: 1 year ]Absolute CD4+ and CD8+ T cell count
- Analytic treatment interruption (ATI) study [ Time Frame: 64 weeks ]Time to first plasma HIV RNA >5000 c/mL
- Impact of pre-ART virus sensitivity to 3BNC117 on ATI outcomes [ Time Frame: Baseline and at viral rebound ]3BNC117 sensitivity determined by PhenoSense and/or HIV env sequencing
- T cell mediated HIV specific immunity [ Time Frame: First of 365 days ]T cell immunity as determined by the HIV AIM assay
- Plasma cytokine and immune activation biomarker levels [ Time Frame: 1 year ]Soluble IL-6, sCD14, sCD163

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV-1 infection
- CD4+ T cell count >200/µL on last visit prior to study entry
- ART naïve
- Able to give informed consent
Exclusion Criteria:
- Any significant acute medical illness (not including primary HIV infection) in the past 8 weeks
- Any evidence of an active AIDS-defining opportunistic infection
- Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate compliance with study therapy
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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:
- Hepatic transaminases (AST or ALT) ≥3 x upper limit of normal (ULN)
- Serum total bilirubin ≥3 ULN
- Estimated glomerular filtration rate (eGFR) ≤60 mL/min (based on serum creatinine or other appropriate validated markers)
- Platelet count ≤100 x10^9/L
- Absolute neutrophil count ≤1x10^9/L
- Serum potassium, magnesium, phosphorus outside ≥1.5 ULN/LLN
- Total calcium (corrected for serum albumin) or ionized calcium ≥1.5 ULN/LLN
- Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
- ECG at screening that shows QTc >450 ms when calculated using the Fridericia formula from either lead V3 or V4 [86]
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Use of:
- Warfarin or warfarin-derivatives
- HDACi
- An agent definitely or possibly associated with effects on QT intervals within 2 weeks of screening
- Drugs that induce or inhibit CYP3A4 or P-gp
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History of:
- Clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for Torsades de pointes (e.g. heart failure)
- Malignancy or transplantation, including skin cancers or Kaposi sarcoma
- Diabetes mellitus
- Receipt of strong immunosuppressive or systemic chemotherapeutic agents within 28 days prior to study entry
- Known resistance to >2 classes of ART
- Known hypersensitivity to the components of romidepsin, 3BNC117 or their analogues
- Women who are pregnant or breastfeeding, or with a positive pregnancy test during screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of non-estrogen containing contraceptions (according to the Danish Medicines Agency guidelines) to avoid pregnancy for the 3 week study period and 4 weeks after study treatment or until undetectable plasma HIV-1 RNA using standard assays
- Males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the 3-week study period, and 4 weeks after study treatment or until undetectable plasma HIV-1 RNA using standard assays

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041012
Denmark | |
Department of Infectious Diseases | |
Aalborg, Denmark | |
Dept. of Infectious Diseases, Aarhus University Hospital | |
Aarhus, Denmark, 8200 | |
Department of Infectious Diseases | |
Hvidovre, Denmark | |
Department of Infectious Diseases | |
København, Denmark | |
Department of Infectious Diseases | |
Odense, Denmark | |
United Kingdom | |
Guy's and St Thomas' | |
London, United Kingdom | |
Imperial College Healthcare NHS Trust | |
London, United Kingdom |
Principal Investigator: | Ole S Søgaard, MD PhD | Aarhus University Hospital |
Responsible Party: | Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT03041012 |
Other Study ID Numbers: |
eCLEAR-001 2015-002234-53 ( EudraCT Number ) |
First Posted: | February 2, 2017 Key Record Dates |
Last Update Posted: | September 13, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Informed Consent Form (ICF) Analytic Code |
Time Frame: | 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 will become available following publication with no planned end date. |
Access Criteria: | Access to the data sharing will be given to researchers who provide a methodologically sound proposal for any type of analysis and requires IRB/Ethics committee approval (if applicable). Proposal should be addressed to olesoega@rm.dk. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV-1 Latency Reversal Agent Immunotherapy |
Anti-Retroviral Agents Romidepsin Antibodies, Blocking Antiviral Agents Anti-Infective Agents |
Antibiotics, Antineoplastic Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |