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Trial History Detail on 2016-04-01

CUHK_CCRB00490

2015-11-25

Prospective

EFV2014

CUHK-NTEC CREC ref 2014.571

KWC-REC ref KW/EX-15-066(86-02)

The Chinese University of Hong Kong

Prof. Lam Tai Ning, Teddy

Dr Leung Wai Shing

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Teddy Lam

Room 801F, 8th Floor, Lo Kwee-seong Integrated Biomedical Sciences Building,
School of Pharmacy, Chinese University of Hong Kong
Shatin, NT
Hong Kong

39436827

teddylam@cuhk.edu.hk

School of Pharmacy, Chinese University of Hong Kong

Hong Kong

Teddy Lam

Room 801F, 8th Floor, Lo Kwee-seong Integrated Biomedical Sciences Building,
School of Pharmacy, The Chinese University of Hong Kong
Shatin, NT
Hong Kong

39436827

teddylam@cuhk.edu.hk

School of Pharmacy, Chinese University of Hong Kong

Hong Kong

A genotype guided low-dose approach to the use of efavirenz in Chinese HIV patients

A genotype guided low-dose approach to the use of efavirenz in Chinese HIV patients

以基因亞型指導低劑量依法韋侖在華裔愛滋病病毒感染者的臨床應用

EFV low dose study

Hong Kong

Yes

2015-06-22

Kowloon West Cluster Research Ethics Committee

KWC-REC ref KW/EX-15-066(86-02)

HIV infection

Drug

Efavirenz, in combination with other anti-retrovirals

tablet

400mg orally daily

4 months

daily

Efavirenz, in combination with other anti-retrovirals

tablet

600mg orally daily

4 months

daily

1) HIV-infected adults older than 18 years old

2) Stable CD4 T-cell counts (over 200 cells per uL) and undetectable viral load (plasma HIV-1 RNA < 75 copies per mL),

3) on HAART containing standard dose EFV and 2 nucleoside/nucleotide reverse transcriptase inhibitors (e.g. tenofovir and emtricitabine).

1) pregnant or nursing mothers;

2) have concurrent opportunistic infection or malignant disease, or any AIDS-defining illness;

3) on treatment or prophylaxis for an opportunistic infection

4) have inadequate renal function (estimated creatinine clearance of <50 mL/min) or significantly deranged laboratory tests (e.g. ALT 1.5x upper limit of normal);

5) have documented non-adherence to study medications or HAART or documented history of illicit substance abuse;

6) illiterate or unable to communicate with study team; or

7) unable or refuse to participate or give consent.

18 years

n/a

Both Male and Female

Interventional

Randomized

simple randomization

Active

Open label

Crossover

4

Dose optimization

2016-01-11

50

Recruiting

Proportion of subject having sufficient viral suppression

viral load < 75 copies per mL

4 months

Plasma concentration of efavirenz

4 months

sleep scale

Pittsburgh Sleep Quality Index (PSQI

occurrence of adverse effects or discontinuation

No

2017-12-01

ChiCTR-IOR-15007465

2015-11-25

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