Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART
NCT ID: NCT03041012
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2017-01-20
2022-12-30
Brief Summary
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Detailed Description
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Subjects will continue ART while receiving LRA romidepsin and/or bNAb 3BNC117.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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antiretrovirals
Standard of care
Antiretrovirals
Combination antiretroviral therapy
antiretrovirals + romidepsin
Standard of care + LRA
Romidepsin
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
Antiretrovirals
Combination antiretroviral therapy
antiretrovirals + 3BNC117
Standard of care + bNAb
3BNC117
30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Antiretrovirals
Combination antiretroviral therapy
antiretrovirals + romidepsin + 3BNC117
Standard of care + LRA + bNAb
Romidepsin
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
3BNC117
30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Antiretrovirals
Combination antiretroviral therapy
Interventions
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Romidepsin
5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
3BNC117
30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
Antiretrovirals
Combination antiretroviral therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4+ T cell count \>200/µL on last visit prior to study entry
* ART naïve
* Able to give informed consent
Exclusion Criteria
* 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
* 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 \[86\]
* 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
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Odense University Hospital
OTHER
Aalborg University Hospital
OTHER
Herning Hospital
OTHER
Hammersmith Hospitals NHS Trust
OTHER
St Mary's Hospital, London
OTHER
Aarhus University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ole S Søgaard, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Infectious Diseases
Aalborg, , Denmark
Dept. of Infectious Diseases, Aarhus University Hospital
Aarhus, , Denmark
Department of Infectious Diseases
Copenhagen, , Denmark
Department of Infectious Diseases
Hvidovre, , Denmark
Department of Infectious Diseases
Odense, , Denmark
Guy's and St Thomas'
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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References
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Gunst JD, Pahus MH, Rosas-Umbert M, Lu IN, Benfield T, Nielsen H, Johansen IS, Mohey R, Ostergaard L, Klastrup V, Khan M, Schleimann MH, Olesen R, Stovring H, Denton PW, Kinloch NN, Copertino DC, Ward AR, Alberto WDC, Nielsen SD, Puertas MC, Ramos V, Reeves JD, Petropoulos CJ, Martinez-Picado J, Brumme ZL, Jones RB, Fox J, Tolstrup M, Nussenzweig MC, Caskey M, Fidler S, Sogaard OS. Early intervention with 3BNC117 and romidepsin at antiretroviral treatment initiation in people with HIV-1: a phase 1b/2a, randomized trial. Nat Med. 2022 Nov;28(11):2424-2435. doi: 10.1038/s41591-022-02023-7. Epub 2022 Oct 17.
Other Identifiers
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2015-002234-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
eCLEAR-001
Identifier Type: -
Identifier Source: org_study_id
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