Romidepsin Plus 3BNC117 Phase 2a Study

Exclusion Criteria

• •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:
• •1. Absolute neutrophil count ≤ 1,000 cells/μl
• •2. Hemoglobin \< 11 gm/dL
• •3. Platelet count \< 125,000 cells/μl
• •4. Alanine Aminotransferase (ALT) ≥ 1.25 x ULN
• •5. Aspartate Aminotransferase (AST) ≥ 1.25 x ULN
• •6. Total bilirubin \> 1.0 ULN
• •7. 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.
• •Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.