Romidepsin Plus 3BNC117 Phase 2a Study

Completed · Phase 2

Conditions studied: Human Immunodeficiency Virus (HIV)

In brief

The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals during an analytical interruption of ART.

Key facts

Study ID

NCT02850016

Run by

Rockefeller University

People needed

48

Starts

2017-01-06

Expected to finish

2020-12-31

Last updated by the study team

2022-07-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18-65 years with documented HIV-1 infection
• CD4+ T-cell count >500 cells/mm3 at screening
• On ART for a minimum of 24 months and HIV-1 RNA plasma level of < 50 copies/ml by standard assays for at least 18 months (a single viral load measurement > 50 but < 500 copies/ml during this time period is allowable).
• Individuals on protease inhibitor or NNRTI-based regimens, or regimens containing cobicistat must be willing to switch to an integrase-inhibitor-based regimen (raltegravir or dolutegravir) prior to enrollment.

You may not qualify if…

• Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the investigators within the last 6 months
• Pregnancy as determined by a positive urine or serum beta-hCG.
• Participant unwilling to use two reliable contraception methods (i.e. condom with spermicide, diaphragm with spermicide, progestin-only containing intrauterine device (IUD) (eg, Mirena, Implanon, Nuva Ring), non-estrogen containing formulations of hormonal birth control drugs with condom) for the study duration.
• Currently breast-feeding.
• History of resistance to 2 or more classes of antiretroviral medications
• Any medical, psychiatric, social, or occupational condition that, as judged by the investigators, would interfere with the evaluation of study objectives (such as severe alcohol or drug abuse, dementia).
• Acute or chronic 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.
• A history of AIDS-defining illness within 3 years prior to enrollment.
• History of B-cell lymphoma, including CNS lymphoma
• CD4 nadir < 200 cells/mm3
• History of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents, or family history of sudden death at age < 50 years.
• ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula from either lead V3 or V4, pathological Q-waves (Q-wave > 40 msec or depth > 0.4-0.5 mV), evidence of a ventricular pre-excitation syndromes, complete or incomplete LBBB or RBBB, second or third degree heart block, QRS duration > 120 msec, or bradycardia defined by sinus rate < 50 bps
• Use of QT-prolonging medication, renal or hepatic disease, structural heart disease or left ventricular dysfunction
• Any symptomatic or asymptomatic arrhythmia excluding sinus arrhythmia and bradycardia ≥ 50 bps.
• Laboratory abnormalities in the parameters listed below:
• Absolute neutrophil count ≤ 1,000 cells/μl
• Hemoglobin < 11 gm/dL
• Platelet count < 125,000 cells/μl
• Alanine Aminotransferase (ALT) ≥ 1.25 x ULN
• Aspartate Aminotransferase (AST) ≥ 1.25 x ULN
• Total bilirubin > 1.0 ULN
• Creatinine > 1.0 ULN
• Any vaccination within 14 days prior to 3BNC117 administration
• Receipt of any therapeutic HIV vaccine in the past
• Receipt of any monoclonal antibody or HDAC inhibitor of any kind in the past.

Where it is running

• The Rockefeller University — New York, New York, United States
• Aarhus University Hospital — Aarhus, Denmark
• University of Cologne — Cologne, Germany

Full record on ClinicalTrials.gov

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