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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01011413




Registration number
NCT01011413
Ethics application status
Date submitted
9/11/2009
Date registered
11/11/2009
Date last updated
21/02/2020

Titles & IDs
Public title
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
Scientific title
A Randomised, Double-blind, Placebo-controlled, Trial to Compare the Safety and Efficacy of Reduced Dose Versus Standard Dose EFV Plus Two Nucleotides (N(t)RTI) in Antiretroviral-naïve HIV-infected Adults Over 96 Weeks
Secondary ID [1] 0 0
NCHECR-ENCORE1
Universal Trial Number (UTN)
Trial acronym
ENCORE1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Efavirenz 600mg
Treatment: Drugs - Efavirenz 400mg

Active comparator: 600 milligram (mg) Efavirenz - Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)

Experimental: 400mg Efavirenz - Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).


Treatment: Drugs: Efavirenz 600mg
3 x EFV 200 milligram (mg) tablets once daily

Treatment: Drugs: Efavirenz 400mg
2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation
Timepoint [1] 0 0
Baseline and 2 years
Secondary outcome [2] 0 0
Mean Change From Baseline in CD4+ T-cell Count
Timepoint [2] 0 0
Baseline and 2 years
Secondary outcome [3] 0 0
Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality
Timepoint [3] 0 0
up to 2 years
Secondary outcome [4] 0 0
Change From Baseline in Metabolic Endpoints
Timepoint [4] 0 0
Baseline and 2 years
Secondary outcome [5] 0 0
Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Change From Baseline in Fasted Insulin Levels
Timepoint [6] 0 0
Baseline and 2 years
Secondary outcome [7] 0 0
Change in Selected Serum Biochemical Parameters
Timepoint [7] 0 0
Baseline and 2 years
Secondary outcome [8] 0 0
Change From Baseline in Estimate Creatinine Clearance
Timepoint [8] 0 0
Baseline and 2 years
Secondary outcome [9] 0 0
Steady-state Efavirenz Concentrations
Timepoint [9] 0 0
Week 4

Eligibility
Key inclusion criteria
* HIV-1 positive by licensed diagnostic test
* aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
* 50 < cluster of differentiation (CD)4 <500 cells/µL
* No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case Definition (except pulmonary tuberculosis)
* HIV RNA =1000 copies/mL
* no prior exposure to antiretroviral therapy (ART) (including short course ART for preventing MTCT)
* calculated creatinine clearance (CLCr) more than or equal to 50 mL/min (Cockcroft-Gault formula)
* provision of written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* the following laboratory values:

* absolute neutrophil count (ANC) <500 cells/µL
* hemoglobin <7.0 g/dL
* platelet count <50,000 cells/µL
* alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal
* pregnant women or nursing mothers
* active opportunistic or malignant disease not under adequate control
* use of immunomodulators within 30 days prior to screening
* use of any prohibited medications
* current alcohol or illicit substance use that might adversely affect study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
636
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Cooper, Professor
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT01011413