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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01495702




Registration number
NCT01495702
Ethics application status
Date submitted
14/12/2011
Date registered
20/12/2011
Date last updated
7/01/2016

Titles & IDs
Public title
Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
Scientific title
A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients
Secondary ID [1] 0 0
2011-004963-56
Secondary ID [2] 0 0
GS-US-236-0121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Immunodeficiency Syndrome 0 0
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 - NNRTI
Treatment: Drugs - FTC/TDF
Treatment: Drugs - Stribild

Experimental: Stribild - Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.

Active Comparator: NNRTI+FTC/TDF - Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.


Treatment: Drugs: NNRTI
NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.

Treatment: Drugs: FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information

Treatment: Drugs: Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

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 FDA-defined Snapshot algorithm was used, which 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 FDA-defined Snapshot algorithm was used, which 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 96
Secondary outcome [2] 0 0
Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [2] 0 0
Baseline; Week 48
Secondary outcome [3] 0 0
Change From Baseline in CD4+ Cell Count at Week 96
Timepoint [3] 0 0
Baseline; Week 96

Eligibility
Key inclusion criteria
- Ability to understand and sign a written informed consent form

- Be stable on the current formulation(s) of an antiretroviral regimen consisting of an
NNRTI plus FTC/TDF for = 6 consecutive months preceding the screening visit. This
includes those who began a regimen with individual drug components and subsequently
simplified to include a fixed-dose combination formulation of the same drugs.

- Be on the first or second antiretroviral regimen with documented undetectable plasma
HIV 1 RNA levels for = 6 months preceding the screening visit

- No previous use of any approved or experimental integrase strand transfer inhibitor
(INSTI) for any length of time

- Documented historical genotype prior to starting initial antiretroviral therapy
showing no known resistance to TDF or FTC

- HIV RNA < 50 copies/mL at screening

- Normal ECG

- Hepatic transaminases = 5 × the upper limit of the normal range (ULN)

- Total bilirubin = 1.5 mg/dL

- Adequate hematologic function

- Serum amylase = 5 × ULN

- Estimated glomerular filtration rate = 70 mL/min

- Females of childbearing potential must agree to utilize protocol recommended
contraception methods or be nonheterosexually active, practice sexual abstinence from
screening throughout the duration of the study period and for 12 weeks for
participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants
following the last dose of study drug

- Female participants who utilize hormonal contraceptive as one of their birth control
methods must have used the same method for at least three months prior to study dosing

- Male participants must agree to utilize protocol-recommended methods of contraception
during heterosexual intercourse or be nonheterosexually active, and practice sexual
abstinence from the screening visit.

- Age = 18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- New AIDS-defining condition diagnosed within the 30 days prior to screening

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Receiving drug treatment for hepatitis C, or those who are anticipated to receive
treatment for hepatitis C during the course of the study

- Experiencing decompensated cirrhosis

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance abuse that would interfere with compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive
cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not
have received any systemic therapy for KS within 30 days of baseline and must not be
anticipated to require systemic therapy during the study.

- Active, serious infections requiring parenteral antibiotic or antifungal therapy
within 30 days prior to baseline

- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3
months of study screening, or expected to receive these agents or systemic steroids
during the study

- Receiving ongoing therapy with any of the medications, including drugs not to be used
with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the
excipients of E/C/F/TDF tablets, or FTC/TDF tablets

- No anticipated need to initiate drugs during the study that are contraindicated

- Receiving other investigational drugs

- Participation in any other clinical trial

- Any other clinical condition or prior therapy that would make 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)
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [2] 0 0
Prahran Market Clinic - South Yarra
Recruitment hospital [3] 0 0
East Sydney Doctors - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
VIC 3141 - South Yarra
Recruitment postcode(s) [3] 0 0
NSW 2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belgium
State/province [16] 0 0
Antwerpen
Country [17] 0 0
Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Besancon
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Frankfurt
Country [27] 0 0
Germany
State/province [27] 0 0
Freiburg
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
München
Country [30] 0 0
Italy
State/province [30] 0 0
Busto Arsizio/Varese
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Rome
Country [34] 0 0
Portugal
State/province [34] 0 0
Lisboa
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan
Country [36] 0 0
Spain
State/province [36] 0 0
Cataluña
Country [37] 0 0
Spain
State/province [37] 0 0
Galicia
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Brighton
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Edinburgh
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the noninferiority of Stribild®
(elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF))
single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse
transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50
copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also
evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of
treatment.
Trial website
https://clinicaltrials.gov/show/NCT01495702
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Damian McColl
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