Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART

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 * 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