drugset / Trial / NCT05230368

Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load

NCT05230368

Non-randomizedSequentialOpen-labelTreatment

Summary

The ANRS 171 SYNACTHIV trial is a monocenter pilot open label phase I trial. This trial will evaluate new procedures in LRA administration in 3 successive cohorts. In case of grade 3 to grade 5 adverse events, the inclusions and treatments will be (but not in a definitive manner) discontinued until the DSMB will conclude that the event was unrelated. Enrolment in cohort 2 then in cohort 3 will start only if no clinical grade 3 to grade 5 adverse event related to the LRAs occurs in the previous cohort.

Timeline

Start
2022-12-14
Primary completion
2025-12-11
Completion
2025-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 5 mg/m2
Subject Romidepsin Peptide 5 mg/m2

Indications