A randomized controlled trial to evaluate the efficacy, acceptability and safety of event-driven pre-exposure prophylaxis for HIV using TAF/FTC in men who have sex with men in Thailand and France

2022-502931-20-00 Protocol ANRS 0029s SimpPrEP Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 22 Jul 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol ANRS 0029s SimpPrEP

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 524
Countries 1
Sites 2

HIV prevention

Key facts

Sponsor
Inserm
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
22 Jul 2024 → ongoing
Decision date (initial)
2023-03-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

HIV prevention

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inserm

7 Total trials 5 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Inserm
Address
101 Rue De Tolbiac
City
Paris
Postcode
75013
Country
France

Scientific contact point

Organisation
Inserm
Contact name
Douae Ammour

Public contact point

Organisation
Inserm
Contact name
Douae Ammour

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 210 2
Rest of world
Thailand
 — 314 —

Investigational sites

France

2 sites · Ongoing, recruiting
Assistance Publique Hopitaux De Paris
Département des Maladies Infectieuses et Tropicales, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Service des maladies infectieuses, 2 Rue Ambroise Pare, 75010, Paris

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2024-07-22 2024-07-22

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-12-23 France Acceptable
2023-03-13
 2023-03-15
2 SUBSTANTIAL MODIFICATION SM-1 2023-04-13 France Acceptable
2023-05-04
 2023-05-31
3 NON SUBSTANTIAL MODIFICATION NSM-1 2023-06-09 France Acceptable
2023-05-04
 2023-06-09
4 SUBSTANTIAL MODIFICATION SM-2 2023-10-13 France Acceptable
2023-11-03
 2023-12-07
5 SUBSTANTIAL MODIFICATION SM-3 2024-12-02 France Acceptable
2025-02-28
 2025-02-28
6 NON SUBSTANTIAL MODIFICATION NSM-3 2025-03-13 France Acceptable
2025-02-28
 2025-03-13

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