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

NCT05230368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

  • HIV-1-infection, Subtype b

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

Sponsors & Collaborators

  • INSERM SC10-US19

    collaborator UNKNOWN

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230368 on ClinicalTrials.gov