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An Open Label Phase I Trial to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals (BCN02-Romi)
The BCN02-Romi study aims to evaluate a combined "kick and kill" strategy using the most immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal agent available at present time (romidepsin) in a cohort of early-treated HIV positive individuals.
Details
| Lead sponsor | IrsiCaixa |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 15 |
| Start date | 2016-02 |
| Completion | 2017-10-30 |
Conditions
- HIV
Interventions
- MVA.HIVconsv vaccine
- Romidepsin
Primary outcomes
- Number of participants with grade >=3 adverse events assessed by Division of AIDS (DAIDS) grading table — Through study completion, maximum 75 weeks
Grade \>=3 adverse events - Number of participants with serious adverse events — Through study completion, maximum 75 weeks
Serious adverse events - Viral reservoir measured by total HIV-1 DNA copies per 10e6 CD4+ T cells — From baseline to visit week 6 (romidepsin 3 + 1 week)
Total HIV-1 DNA copies per 10e6 CD4+ T cells
Countries
Spain