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

Start 5 Dec 2022 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol ANRS 171 SYNACTHIV

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ongoing, recruitment ended

Participants planned 15

Countries 1

Sites 1

HIV

Key facts

Sponsor: ANRS Maladies Infectieuses Emergentes
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trial duration: 5 Dec 2022 → ongoing
Decision date (initial): 2024-10-16
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-518141-13-00
EudraCT number: 2017-004575-31
ClinicalTrials.gov: NCT05230368

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

HIV

Version	Level	Code	Term	System organ class
20.1	LLT	10068341	HIV-1 infection	10021881

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ANRS Maladies Infectieuses Emergentes

Sponsor organisation: ANRS Maladies Infectieuses Emergentes
Address: 101 Rue De Tolbiac
City: Paris
Postcode: 75013
Country: France

Scientific contact point

Organisation: ANRS Maladies Infectieuses Emergentes
Contact name: Manon Ollivier

Public contact point

Organisation: ANRS Maladies Infectieuses Emergentes
Contact name: Manon Ollivier

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruitment ended	15	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ongoing, recruitment ended

CHU Saint-Pierre

Maladies infectieuses, Rue aux Laines 105, 1000, Bruxelles

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2022-12-05		2022-12-14	2025-07-15

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-09-30	Belgium	Acceptable 2024-10-16	2024-10-16
2	SUBSTANTIAL MODIFICATION	SM-1	2026-01-06	Belgium	Acceptable 2026-02-04	2026-02-16