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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01309243
Registration number
NCT01309243
Ethics application status
Date submitted
3/03/2011
Date registered
7/03/2011
Date last updated
25/02/2015
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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Scientific title
A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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Secondary ID [1]
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GS-US-264-0110
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - FTC/RPV/TDF
Treatment: Drugs - EFV/FTC/TDF
Experimental: FTC/RPV/TDF -
Experimental: EFV/FTC/TDF -
Treatment: Drugs: FTC/RPV/TDF
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal
Treatment: Drugs: EFV/FTC/TDF
Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime
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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 HIV-1 RNA < 50 Copies/mL at Week 48
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Assessment method [1]
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The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.
The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
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Assessment method [1]
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The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.
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Timepoint [1]
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Baseline to Week 96
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Secondary outcome [2]
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Change From Baseline in CD4 Cell Count at Week 48
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 48
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Secondary outcome [3]
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Change From Baseline in CD4 Cell Count at Week 96
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Change From Baseline in Fasting Total Cholesterol at Week 48
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Assessment method [4]
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Secondary outcome [5]
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Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48
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Secondary outcome [6]
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Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Change From Baseline in Fasting Triglycerides at Week 48
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Assessment method [7]
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Timepoint [7]
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Baseline to Week 48
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Secondary outcome [8]
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Development of HIV-1 Drug Resistance Through Week 96, All Participants
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Assessment method [8]
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Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA = 50 copies/mL and \< 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA = 400 copies/mL after achieving HIV-1 RNA \< 50 copies/mL, or as having 2 consecutive visits with \> 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA = 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
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Timepoint [8]
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Baseline to Week 96
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Secondary outcome [9]
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Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance
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Assessment method [9]
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Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA = 50 copies/mL and \< 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA = 400 copies/mL after achieving HIV-1 RNA \< 50 copies/mL, or as having 2 consecutive visits with \> 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA = 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
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Timepoint [9]
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Baseline to Week 96
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Eligibility
Key inclusion criteria
* Ability to understand and sign a written informed consent form
* Plasma HIV-1 RNA levels = 2,500 copies/mL at screening
* No prior use of any approved or experimental anti-HIV drug for any length of time
* Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
* Normal ECG
* Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) = 5 x the upper limit of the normal range (ULN)
* Total bilirubin = 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* Serum amylase = 5 x ULN (participants with serum amylase > 5 x ULN remained eligible if serum lipase was = 5 x ULN)
* Adequate renal function
* Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
* Adult (= 18 years) males or non-pregnant females
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Minimum age
18
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
* A new AIDS-defining condition diagnosed within the 30 days prior to screening
* Females who were breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Proven or suspected acute hepatitis in the 30 days prior to study entry
* Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to receive treatment for hepatitis C during the course of the study
* Subjects experiencing decompensated cirrhosis
* Had an implanted defibrillator or pacemaker
* Current alcohol or substance abuse
* A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
* Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial.
* Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and other immune-based or cytokine-based therapies)
* Had any other clinical condition or prior therapy that, in the opinion of the Investigator, would have made the participant unsuitable for the study or unable to comply with the dosing requirements
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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
Open (masking not used)
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Who is / are masked / blinded?
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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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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
1/02/2011
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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
1/02/2014
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Sample size
Target
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Accrual to date
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Final
799
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Darlinghurst
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St Vincent's Hospital, Sydney - Darlinghurst
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Taylor Square Private Clinic - Darlinghurst
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Clinical Research - Infectious Diseases Unit Alfred Hospital - Melbourne
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Northside Clinic - North Fitzroy
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Prahran Market Clinic - Prahran
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Albion Street Centre - Surry Hills
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East Sydney Doctors - Sydney
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02010 - Darlinghurst
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03004 - Melbourne
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03068 - North Fitzroy
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Recruitment postcode(s) [4]
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03181 - Prahran
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02010 - Surry Hills
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Recruitment postcode(s) [6]
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02010 - Sydney
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
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Summary
Brief summary
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (= 100,000 copies/mL or \> 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
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Trial website
https://clinicaltrials.gov/study/NCT01309243
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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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Todd Fralich, M.D.
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Address
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Gilead Sciences
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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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01309243
Download to PDF