Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00490

2 Trial Registration Date

2015-11-25

i Registration Status

Prospective

3 Secondary IDs

EFV2014

CUHK-NTEC CREC ref 2014.571

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

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

Prof. Lam Tai Ning, Teddy

6 Secondary Sponsor

Dr Leung Wai Shing

Function

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

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Teddy Lam

ii Address

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

iii Phone

39436827

iv Email

teddylam@cuhk.edu.hk

v Affiliation

School of Pharmacy, Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Teddy Lam

ii Address

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

iii Phone

39436827

iv Email

teddylam@cuhk.edu.hk

v Affiliation

School of Pharmacy, Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

EFV low dose study

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-06-22

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

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

14 Medical Condition Being Studied

HIV infection

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Efavirenz, in combination with other anti-retrovirals

iii Dosage form of the intervention

tablet

iv Dosage of the intervention

400mg orally daily

v Duration of the intervention

4 months

vi Frequency of the intervention

daily

16 Comparative Treatments

i Description/ name of comparative treatments

Efavirenz, in combination with other anti-retrovirals

ii Dosage form of the comparative treatments

tablet

iii Dosage of the comparative treatments

600mg orally daily

iv Duration of the comparative treatments

4 months

v Frequency of the comparative treatments

daily

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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).

ii Exclusion Criteria

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.

iii Age Minimum

18 years

iv Age Maximum

n/a

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

simple randomization

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

4

Please specify

vi Study Objectives (Optional)

Dose optimization

20 Anticipated trial start date

2016-01-11

21 Target Sample Size

50

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Proportion of subject having sufficient viral suppression

ii The metric or method of measurement used

viral load < 75 copies per mL

iii The timepoint(s) of primary interest

4 months

24 Secondary Outcome

i The Name of the outcome

Plasma concentration of efavirenz

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

4 months

Secondary Outcome

i The Name of the outcome

sleep scale

ii The metric or method of measurement used

Pittsburgh Sleep Quality Index (PSQI

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

occurrence of adverse effects or discontinuation

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-12-01

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15007465

28 Date of Registration in Primary Registry

2015-11-25

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Trial History Detail on 2016-04-01