CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
3BNC117 +1 moredrug
Likely dose
Romidepsin: Intravenous Infusion; 3BNC117: Intravenous Infusion (specific doses not stated)AI-extracted
Key inclusion· 4
  • ✓Adults age 18-65 years with documented HIV-1 infection
  • ✓CD4+ T-cell count >500 cells/mm3 at screening
  • ✓On ART for minimum 24 months with HIV-1 RNA <50 copies/ml for at least 18 months
  • ✓Willing to switch to integrase-inhibitor-based ART (raltegravir or dolutegravir) if currently on protease inhibitor, NNRTI, or cobicistat-based regimens
Key exclusion· 12
  • ✕History of resistance to 2 or more classes of antiretroviral medications
  • ✕Acute or chronic hepatitis B or C infection as indicated by presence of HBsAg or HCV-RNA in blood
  • ✕AIDS-defining illness within 3 years prior to enrollment
  • ✕CD4 nadir <200 cells/mm3

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02850016
NCT02850016Phase 2Completed
CompareCT.gov

A Phase 2a, Randomized Study of Romidepsin With or Without 3BNC117 to Evaluate the Effects on the HIV-1 Reservoir (ROADMAP)

Rockefeller University·interventional·Posted Jul 29, 2016·Updated Jul 14, 2022

In Brief

A Phase 2 clinical trial evaluating 3BNC117 and Romidepsin for Human Immunodeficiency Virus (HIV). Completed, enrolled 48 participants across 3 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV)
CountriesDenmark, Germany, United States
CollaboratorsUniversity Hospital of Cologne, Aarhus University Hospital

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartJan 6, 2017
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.9 years ago

Interventions

3BNC117drug

Intravenous Infusion of 3BNC117

Romidepsindrug

Intravenous Infusion of Romidepsin