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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/NCT01815736




Registration number
NCT01815736
Ethics application status
Date submitted
19/03/2013
Date registered
21/03/2013
Date last updated
13/04/2021

Titles & IDs
Public title
Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Scientific title
A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Secondary ID [1] 0 0
2012-005114-20
Secondary ID [2] 0 0
GS-US-292-0109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 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 - E/C/F/TAF
Treatment: Drugs - E/C/F/TDF
Treatment: Drugs - EFV/FTC/TDF
Treatment: Drugs - RTV
Treatment: Drugs - ATV
Treatment: Drugs - FTC/TDF
Treatment: Drugs - COBI

Experimental: E/C/F/TAF - Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

Active Comparator: Stay on Baseline Treatment Regimen (SBR) - Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks.
Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.


Treatment: Drugs: E/C/F/TAF
150/150/200/10 mg FDC tablet administered orally once daily

Treatment: Drugs: E/C/F/TDF
150/150/200/300 mg FDC tablet administered orally once daily

Treatment: Drugs: EFV/FTC/TDF
600/200/300 mg FDC tablet administered orally once daily

Treatment: Drugs: RTV
100 mg tablet administered orally once daily

Treatment: Drugs: ATV
300 mg capsule administered orally once daily

Treatment: Drugs: FTC/TDF
200/300 mg tablet administered orally once daily

Treatment: Drugs: COBI
150 mg tablet administered orally once daily
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
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Timepoint [1] 0 0
Baseline; Week 48
Secondary outcome [2] 0 0
Percent Change From Baseline in Spine BMD at Week 48
Timepoint [2] 0 0
Baseline; Week 48
Secondary outcome [3] 0 0
Change From Baseline in Serum Creatinine at Week 48
Timepoint [3] 0 0
Baseline; Week 48
Secondary outcome [4] 0 0
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
Timepoint [4] 0 0
Baseline; Week 48
Secondary outcome [5] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Timepoint [5] 0 0
Week 96
Secondary outcome [6] 0 0
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48
Timepoint [6] 0 0
Week 48
Secondary outcome [7] 0 0
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96
Timepoint [7] 0 0
Week 96
Secondary outcome [8] 0 0
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Timepoint [8] 0 0
Baseline; Week 48
Secondary outcome [9] 0 0
Change From Baseline in CD4 Cell Count at Weeks 96
Timepoint [9] 0 0
Baseline; Week 96

Eligibility
Key inclusion criteria
Key

- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures

- Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF,
RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for = 6 consecutive months preceding the final
visit in their earlier study

- Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103,
GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only
participants on an EFV-based regimen), or completion of studies GS-US-236-0104,
GS-US-216-0105

- Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations
at undetectable levels for at least 6 consecutive months prior to the screening visit
and have HIV RNA < 50 copies/mL at the screening visit

- Normal echocardiograph (ECG)

- Estimated glomerular filtration rate (GFR) = 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance

- Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase
[ALT]) = 5 × upper limit of the normal range (ULN)

- Direct bilirubin = 1.5 x ULN

- Adequate hematologic function

- Serum amylase = 5 × ULN

- Females of childbearing potential must agree to utilize highly effective contraception
methods or be non-heterosexually active or practice sexual abstinence from screening
throughout the duration of study treatment and for 12 weeks following the last dose of
study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all
other regimens.

- 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

- Female participants who have stopped menstruating for = 12 months but do not have
documentation of ovarian hormonal failure must have a serum follicle stimulating
hormone (FSH) level at screening within the post-menopausal range based on the Central
Laboratory reference range

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
the 30 days prior to screening

- Hepatitis B surface antigen position

- Hepatitis C antibody positive

- Participants experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the subject unsuitable for the study or unable to comply with
dosing requirements

- Participation in any other clinical trial without prior approval from the sponsor is
prohibited while participating in this trial

- Participants receiving ongoing therapy with drugs not to be used with elvitegravir
(EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies
to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
27/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2020
Sample size
Target
Accrual to date
Final
1443
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical practice - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [4] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [5] 0 0
Albion Street Centre - Surry Hills
Recruitment hospital [6] 0 0
Melbourne Sexual Health Clinic - Carlton
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Northside Clinic - Melbourne
Recruitment hospital [9] 0 0
Prahran Market Clinic - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3068 - Melbourne
Recruitment postcode(s) [6] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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California
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United States of America
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Colorado
Country [6] 0 0
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Austria
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Graz
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Ghent
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Quebec
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Copenhagen
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Dominican Republic
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France
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Lyon
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Nantes
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Germany
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Bonn
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Freiburg
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Hamburg
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Germany
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Köln
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Germany
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München
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Italy
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Milano
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Italy
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Milan
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Italy
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Rome
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Italy
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Torino
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Mexico
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Guadalajara
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Netherlands
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Amsterdam
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Rotterdam
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Portugal
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Lisbon
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Portugal
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Porto
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Spain
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Barcelona
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Madrid
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Spain
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Sevilla
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Sweden
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Stockholm
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Switzerland
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Bern
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Switzerland
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Lausanne
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Switzerland
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Zürich
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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United Kingdom
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Brighton
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United Kingdom
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London
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United Kingdom
State/province [75] 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 primary objective of this study is to evaluate the non-inferiority of switching to a
tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining
tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically
suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week
48.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01815736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01815736