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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
GS-US-264-0110
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 - 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.
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 - The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.
Timepoint [1] 0 0
Baseline to Week 96
Secondary outcome [2] 0 0
Change From Baseline in CD4 Cell Count at Week 48
Timepoint [2] 0 0
Baseline to Week 48
Secondary outcome [3] 0 0
Change From Baseline in CD4 Cell Count at Week 96
Timepoint [3] 0 0
Baseline to Week 96
Secondary outcome [4] 0 0
Change From Baseline in Fasting Total Cholesterol at Week 48
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48
Timepoint [5] 0 0
Baseline to Week 48
Secondary outcome [6] 0 0
Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48
Timepoint [6] 0 0
Baseline to Week 48
Secondary outcome [7] 0 0
Change From Baseline in Fasting Triglycerides at Week 48
Timepoint [7] 0 0
Baseline to Week 48
Secondary outcome [8] 0 0
Development of HIV-1 Drug Resistance Through Week 96, All Participants - 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.
Timepoint [8] 0 0
Baseline to Week 96
Secondary outcome [9] 0 0
Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance - 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.
Timepoint [9] 0 0
Baseline to Week 96

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [4] 0 0
Clinical Research - Infectious Diseases Unit Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Northside Clinic - North Fitzroy
Recruitment hospital [6] 0 0
Prahran Market Clinic - Prahran
Recruitment hospital [7] 0 0
Albion Street Centre - Surry Hills
Recruitment hospital [8] 0 0
East Sydney Doctors - Sydney
Recruitment postcode(s) [1] 0 0
02010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
03004 - Melbourne
Recruitment postcode(s) [3] 0 0
03068 - North Fitzroy
Recruitment postcode(s) [4] 0 0
03181 - Prahran
Recruitment postcode(s) [5] 0 0
02010 - Surry Hills
Recruitment postcode(s) [6] 0 0
02010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Austria
State/province [26] 0 0
Graz
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Vienna
Country [29] 0 0
Belgium
State/province [29] 0 0
Antwerp
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
France
State/province [35] 0 0
Garches
Country [36] 0 0
France
State/province [36] 0 0
Lyon
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Nice
Country [39] 0 0
France
State/province [39] 0 0
Paris cedex 13
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Tourcoing
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Bonn
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Frankfurt am Main
Country [46] 0 0
Germany
State/province [46] 0 0
Freiburg
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
München
Country [49] 0 0
Italy
State/province [49] 0 0
Bergamo
Country [50] 0 0
Italy
State/province [50] 0 0
Milano
Country [51] 0 0
Italy
State/province [51] 0 0
Milan
Country [52] 0 0
Italy
State/province [52] 0 0
Monza
Country [53] 0 0
Italy
State/province [53] 0 0
Pavia
Country [54] 0 0
Italy
State/province [54] 0 0
Rome
Country [55] 0 0
Netherlands
State/province [55] 0 0
Amsterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Rotterdam
Country [57] 0 0
Portugal
State/province [57] 0 0
Lisbon
Country [58] 0 0
Portugal
State/province [58] 0 0
Porto
Country [59] 0 0
Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
Spain
State/province [60] 0 0
Alicante
Country [61] 0 0
Spain
State/province [61] 0 0
Cataluña
Country [62] 0 0
Spain
State/province [62] 0 0
Elche
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Switzerland
State/province [64] 0 0
Bern
Country [65] 0 0
Switzerland
State/province [65] 0 0
Lausanne
Country [66] 0 0
Switzerland
State/province [66] 0 0
Zurich
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Brighton
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Edinburgh
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01309243
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Todd Fralich, M.D.
Address 0 0
Gilead Sciences
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

Summary results
Other publications