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COMPLETED
NCT05230368
PHASE1

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

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

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.

Official title: A Pilot Open Label Phase I Trial to Evaluate the Safety and the Tolerability of a Combination of Two HIV-1 Inducers in HIV+ Sub-type B Patients Under cART With Undetectable Viral Load

Key Details

Gender

MALE

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2022-12-14

Completion Date

2025-12-11

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

Decitabine cycle 1

Decitabine administration (5mg/m²) at days 1, 2, 3

DRUG

Romidepsin cycle 1

Romidepsin administration (5mg/m²) at days 4, 11, 18

DRUG

Decitabine cycle 2

Decitabine administration (5mg/m²) at days 35, 36, 37

DRUG

Romidepsin cycle 2

Romidepsin administration (5mg/m²) at days 38, 45, 52

DRUG

Decitabine cycle 3

Decitabine administration (5mg/m²) at days 70, 71, 72

DRUG

Romidepsin cycle 3

Romidepsin administration (5mg/m²) at days 73, 80, 87

DRUG

Decitabine cycle 4

Decitabine administration (5mg/m²) at days 105, 106, 107

DRUG

Romidepsin cycle 4

Romidepsin administration (5mg/m²) at days 108, 115, 122

Locations (4)

CHU Saint-Pierre

Brussels, Belgium

Antoine CHERET

Le Kremlin-Bicêtre, France

LAMBOTTE Olivier

Le Kremlin-Bicêtre, France

Odile LAUNAY

Paris, France