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Clinical Trials/EUCTR2015-005238-23-DE
EUCTR2015-005238-23-DEActive, not recruitingPhase 1

A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP) - ROADMAP

The Rockefeller University0 sites30 target enrollmentStarted: December 21, 2016Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1) Adults age 18-65 years with documented HIV-1 infection
  • •2) CD4+ T-cell count >500 cells/mm3 at screening
  • •3) On ART for a minimum of 18 months and HIV-1 RNA plasma level of < 50 copies/ml by standard assays for at least 12 months (a single viral load measurement > 50 but < 500 copies/ml during this time period is allowable).
  • •4) Individuals on protease inhibitor or NNRTI-based regimens must be willing to switch to an integrase-inhibitor-based regimen (raltegravir or dolutegravir) prior to enrollment.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 30
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1) Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the investigators within the last 6 months
  • •2) Pregnancy as determined by a positive urine beta-hCG.
  • •3) Participant unwilling to use two reliable contraception methods (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) for the study duration.
  • •4) Currently breast-feeding.
  • •5) History of resistance to 2 or more classes of antiretroviral medication
  • •6) 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).
  • •7) 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.
  • •8) Receipt of an HDAC inhibitor within 2 years prior to enrollment or 3BNC117 in the past.
  • •9) Have a history of AIDS-defining illness within 3 years prior to enrollment.
  • •10) History of significant coronary artery disease, myocardial infarction, percutaneous coronary intervention with placement of cardiac stents.
  • •11) ECG at screening that shows QTc >450 msec when calculated using the Fridericia formula from either lead V3 or V4.
  • •12) Use of Coumadin or Coumadin derivatives
  • •13) Laboratory abnormalities in the parameters listed below:
  • •13a) Absolute neutrophil count = 1,300
  • •13b) Hemoglobin = 10 g/dL
  • •13c) Platelet count = 125,000
  • •13d) ALT = 1.5 x ULN
  • •13e) AST = 1.5 x ULN
  • •13f) Total bilirubin = 2.0 x ULN (for participants on atazanavir, a total bilirubin up to 3 x ULN is allowable)
  • •13g) eGFR < 60 mL/min/1.73m2
  • •14) Any vaccination within 14 days prior to 3BNC117 administration
  • •15) Receipt of any therapeutic HIV vaccine in the past
  • •16) Receipt of an anti-HIV monoclonal antibody therapy in the past
  • •17) Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.

Investigators

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