drugset / Trial / NCT05230368
Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 5 mg/m2 | — |
| Subject | Romidepsin | Peptide | 5 mg/m2 | — |