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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
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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
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Secondary ID [1]
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NCHECR-ENCORE1
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Universal Trial Number (UTN)
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Trial acronym
ENCORE1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Plasma HIV-1 RNA <200 Copies/mL 48 Weeks After Randomisation
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Assessment method [1]
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Percentage of participants in each of the treatment arms with centrally quantified plasma HIV-1 RNA viral load <200 copies/mL 48 weeks after randomisation.
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Timepoint [1]
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48 weeks
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Secondary outcome [1]
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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL and <50 Copies/mL at 48 and 96 Weeks After Randomisation
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Assessment method [1]
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Percentage of participants in each of the two treatment arms with plasma HIV-1 RNA <400 copies/mL and <50 copies/mL at 48 and 96 weeks after randomisation
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Timepoint [1]
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Baseline and 2 years
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Secondary outcome [2]
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Mean Change From Baseline in CD4+ T-cell Count
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Assessment method [2]
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Mean change from baseline to week 96 in CD4+ T-cell count/mm3 between the two treatment arms
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Timepoint [2]
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Baseline and 2 years
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Secondary outcome [3]
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Clinical Endpoints: Opportunistic Disease or Death, and Serious Non-AIDS-defining Events and Non-AIDS-related Mortality
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Assessment method [3]
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Number of participants in each randomised arm diagnosed with a serious non-AIDS defining event, who die from an AIDS-defining event, who die from a non-AIDS-defining event
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Timepoint [3]
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up to 2 years
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Secondary outcome [4]
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Change From Baseline in Metabolic Endpoints
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Assessment method [4]
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Change from baseline to week 96 in fasted total cholesterol, high density cholesterol and low density cholesterol, and glucose between randomised treatment arms
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Timepoint [4]
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Baseline and 2 years
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Secondary outcome [5]
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Adherence: Median Scores of Self-reported Adherence to Randomised Study Medications
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Assessment method [5]
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AIDS Clinical Trials Group (ACTG) 7-day adherence questionnaire scores. Maximum value is all pills taken every day; minimum value is no pills taken per day. Higher scores indicate a better outcome.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Change From Baseline in Fasted Insulin Levels
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Assessment method [6]
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Change from baseline to week 96 in fasted insulin levels
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Timepoint [6]
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Baseline and 2 years
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Secondary outcome [7]
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Change in Selected Serum Biochemical Parameters
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Assessment method [7]
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Change from baseline to week 96 in alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase levels between randomised treatment arms
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Timepoint [7]
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Baseline and 2 years
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Secondary outcome [8]
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Change From Baseline in Estimate Creatinine Clearance
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Assessment method [8]
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Change from baseline to week 96 in estimate creatinine clearance between randomised treatment arms
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Timepoint [8]
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Baseline and 2 years
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Secondary outcome [9]
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Steady-state Efavirenz Concentrations
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Assessment method [9]
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Steady-state efavirenz mid-dosing interval plasma concentrations
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Timepoint [9]
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Week 4
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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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
636
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment postcode(s) [1]
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2010 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV),
could be reduced without compromising its effectiveness. Lower drug doses could have fewer
side effects and would make EFV more affordable. The purpose of this study is to compare the
safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV
in controlling HIV as part of initial combination antiretroviral therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01011413
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Cooper, Professor
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Address
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Kirby Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01011413
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