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Trial History Detail on 2018-05-02

CUHK_CCRB00606

2018-05-02

Prospective

2.1

AIDS Trust Fund

Stanley Ho Centre for Emerging Infectious Diseases

N/A

Not Applicable

Shui Shan Lee

Room 207, Postgraduate Education Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

22528812

sslee@cuhk.edu.hk

Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong

Hong Kong

Shui Shan Lee

Room 207, Postgraduate Education Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

22528812

sslee@cuhk.edu.hk

Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong

Hong Kong

Pre-exposure prophylaxis with on-demand versus daily TDF/FTC in men who have sex with men at high risk of HIV infection – a crossover study

Pre-exposure prophylaxis with on-demand versus daily TDF/FTC in men who have sex with men at high risk of HIV infection – a crossover study

《接觸前預防投藥》交叉研究

Crossover PrEP

Hong Kong

Yes

2017-01-10

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.719

HIV infection

Drug

HIV prevention / Daily pre-exposure prophylaxis / truvada

Truvada tablet (Tenofovir 300 mg / Emtricitabine 200 mg)

1 tablet

16 weeks

daily

HIV prevention / Daily pre-exposure prophylaxis / truvada

Truvada tablet (Tenofovir 300 mg / Emtricitabine 200 mg)

2 tablets before sex, and 1 tablet at 24 and then 48 hours afterwards

16 weeks

on demand

men who have sex with men (MSM)

18 years old or above

able to communicate in written and spoken English or Chinese

inclination to engage in unprotected anal sex

a history of unprotected anal sex, especially as receptive partner, within the preceding 6 months

normally resident in Hong Kong

referral from an HIV counselling service

prisoner

having any form of mental illnesses

inability or refusal to give consent

HIV positive

known renal insufficiency with creatinine clearance <60mL/min

known hepatitis B carrier

18

999

Male

Interventional

Randomized

computer-generated random sequence

Dose comparison

Open label

Crossover

4

(a) compare the adherence between on-demand and daily PrEP; (b) examine the preferred regimen; (c) characterise the pattern of risk compensation following PrEP

2018-07-01

90

Not Yet Recruiting

Adherence rate

no. of tablets actually taken / no. of tablets required in the protocol

Week 0 - 34

Coverage of unprotected sex episodes by PrEP

no. unprotected sex covered by PrEP / no. unprotected sex

Weeks 0 - 34

Proportion fully adherent to the protocol

no. visits actually attended / no. visits required in the protocol

Week 34

Discontinuation rate

no. of dropouts / no. enrolled

Week 34

Rate of risk compensation

STI incidence

Weeks 0 - 34

No

2019-08-13

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