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Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02616029
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : November 4, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Drug: E/C/F/TAF
Enrollment 66
Recruitment Details Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 17 December 2015. The last study visit occurred on 11 July 2019.
Pre-assignment Details 120 participants were screened.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF
Hide Arm/Group Description Participants with M184V and/or M184I mutations in reverse transcriptase and without any other nucleos(t)ide reverse transcriptase inhibitor (NRTI)-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet orally once daily for 48 weeks. Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (TAMs) switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Period Title: Overall Study
Started 38 28
Completed 34 26
Not Completed 4 2
Reason Not Completed
Adverse Event             1             0
Death             0             1
Protocol Violation             1             0
Withdrew Consent             1             0
Enrolled and Never Treated             1             1
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total
Hide Arm/Group Description Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 37 27 64
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 27 participants 64 participants
50  (9.2) 52  (9.5) 51  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 27 participants 64 participants
Female 8 9 17
Male 29 18 47
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 37 participants 27 participants 64 participants
Hispanic or Latino 6 4 10
Not Hispanic or Latino 27 21 48
Not Permitted 4 2 6
[1]
Measure Description: For participants in Not Permitted category: local regulators did not allow collection of ethnicity information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 37 participants 27 participants 64 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Black 7 8 15
Native Hawaiian or Pacific Islander 0 0 0
White 27 17 44
Not Permitted 3 2 5
[1]
Measure Description: For participants in Not Permitted category: local regulators did not allow collection of ethnicity information.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 27 participants 64 participants
United States 3 5 8
Italy 2 3 5
France 14 15 29
Germany 4 1 5
Spain 14 3 17
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 37 participants 27 participants 64 participants
1.29  (0.056) 1.29  (0.046) 1.29  (0.052)
HIV-1 RNA Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 27 participants 64 participants
< 50 copies/mL 37 27 64
≥ 50 copies/mL 0 0 0
Cluster Determinant 4+ (CD4+) Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 37 participants 27 participants 64 participants
740  (319.6) 665  (312.7) 708  (316.4)
CD4+ Cell Count Categories  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 27 participants 64 participants
< 50 cells/µL 0 0 0
≥ 50 to < 200 cells/µL 1 2 3
≥ 200 to < 350 cells/µL 3 1 4
≥ 350 to < 500 cells/µL 4 5 9
≥ 500 cells/µL 29 19 48
HIV Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 27 participants 64 participants
Asymptomatic 30 23 53
Symptomatic HIV Infection 4 1 5
Acquired Immune Deficiency Syndrome (AIDS) 3 3 6
CD4 Percentage (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage of CD4 cells
Number Analyzed 37 participants 27 participants 64 participants
32.9  (10.12) 31.2  (11.43) 32.2  (10.63)
1.Primary Outcome
Title Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)
Hide Description The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all the randomized participants who received at least one dose of study drug and excluded participants with any major protocol violations.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(90.3 to 100.0)
100.0
(86.8 to 100.0)
100.0
(94.2 to 100.0)
2.Secondary Outcome
Title Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase
Hide Description Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit.
Time Frame Day 1 up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were included in the analysis.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR
Hide Description The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(90.3 to 100.0)
100.0
(86.8 to 100.0)
100.0
(94.2 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR
Hide Description The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(90.3 to 100.0)
100.0
(86.8 to 100.0)
100.0
(94.2 to 100.0)
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
96.2
(80.4 to 99.9)
93.5
(84.3 to 98.2)
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
100.0
(86.8 to 100.0)
95.2
(86.5 to 99.0)
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(73.9 to 96.9)
96.2
(80.4 to 99.9)
91.9
(82.2 to 97.3)
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
96.2
(80.4 to 99.9)
93.5
(84.3 to 98.2)
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(73.9 to 96.9)
100.0
(86.8 to 100.0)
93.5
(84.3 to 98.2)
10.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis
Hide Description The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 48 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 295 and 378 (inclusive).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.9
(73.9 to 96.9)
96.2
(80.4 to 99.9)
91.9
(82.2 to 97.3)
11.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.2
(85.5 to 99.9)
96.2
(80.4 to 99.9)
96.8
(88.8 to 99.6)
12.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
100.0
(86.8 to 100.0)
95.2
(86.5 to 99.0)
13.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 36 26 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(77.5 to 98.2)
96.2
(80.4 to 99.9)
93.5
(84.3 to 98.2)
14.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 35 26 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(90.0 to 100.0)
96.2
(80.4 to 99.9)
98.4
(91.2 to 100.0)
15.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 26 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(89.4 to 100.0)
100.0
(86.8 to 100.0)
100.0
(93.9 to 100.0)
16.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 25 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(89.4 to 100.0)
100.0
(86.3 to 100.0)
100.0
(93.8 to 100.0)
17.Secondary Outcome
Title Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 25 58
Mean (Standard Deviation)
Unit of Measure: cells/µL
-47  (194.1) -6  (116.1) -30  (165.1)
18.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: cells/µL
-40  (162.1) 28  (212.5) -10  (187.4)
19.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 31 25 56
Mean (Standard Deviation)
Unit of Measure: cells/µL
-6  (131.9) 27  (120.4) 9  (126.8)
20.Secondary Outcome
Title Change From Baseline in CD4 Percentage (%) at Week 12
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 25 58
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
-0.4  (3.37) 1.5  (3.01) 0.4  (3.33)
21.Secondary Outcome
Title Change From Baseline in CD4 % at Week 24
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 33 26 59
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
0.1  (3.25) 1.1  (4.30) 0.5  (3.75)
22.Secondary Outcome
Title Change From Baseline in CD4 % at Week 48
Hide Description [Not Specified]
Time Frame Baseline (Day 1); Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
Hide Arm/Group Description:
Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 TAMs switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
Overall Number of Participants Analyzed 31 25 56
Mean (Standard Deviation)
Unit of Measure: percentage of CD4 cells
0.2  (3.12) 1.5  (3.64) 0.8  (3.39)
Time Frame First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included all participants who received at least 1 dose of study drug. Safety data for overall study population is presented in this section as all participants received same treatment.
 
Arm/Group Title Total E/C/F/TAF
Hide Arm/Group Description Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
All-Cause Mortality
Total E/C/F/TAF
Affected / at Risk (%)
Total   1/64 (1.56%) 
Hide Serious Adverse Events
Total E/C/F/TAF
Affected / at Risk (%)
Total   5/64 (7.81%) 
General disorders   
Death  1  1/64 (1.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung adenocarcinoma  1  1/64 (1.56%) 
Prostatic adenoma  1  1/64 (1.56%) 
Tonsil cancer  1  1/64 (1.56%) 
Renal and urinary disorders   
Acute kidney injury  1  1/64 (1.56%) 
Proteinuria  1  1/64 (1.56%) 
Renal failure  1  1/64 (1.56%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total E/C/F/TAF
Affected / at Risk (%)
Total   26/64 (40.63%) 
Gastrointestinal disorders   
Diarrhoea  1  5/64 (7.81%) 
General disorders   
Asthenia  1  7/64 (10.94%) 
Infections and infestations   
Bronchitis  1  7/64 (10.94%) 
Nasopharyngitis  1  7/64 (10.94%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  5/64 (7.81%) 
Nervous system disorders   
Dizziness  1  4/64 (6.25%) 
Headache  1  6/64 (9.38%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/64 (7.81%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications:
Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, Margot N, Shao Y, Piontkowsky D, Das M, McNicholl IR, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V/I (GS-US-292-1824): Week 24 Results [Poster PE13/20]. 17th European AIDS Conference (EACS), 6-9 November 2019, Basel, Switzerland.
Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single-Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 24 Results [Oral abstract]. 22nd International AIDS Conference, 23-27 July 2018, Amsterdam, The Netherlands.
Perez-Valero I, Llibre JM, Lazzarin A, di Perri G, Pulido F, Molina JM, Esser S, McNicholl IR, Lorgeoux RP, Margot N, Shao Y, Piontkowsky D, Das M, Haubrich R. A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen in Virologically-Suppressed HIV-1 Infected Adults Harboring the NRTI Resistance Mutation M184V and/or M184I (GS-US-292-1824): Week 12 Results [Poster]. XXVI International Workshop on HIV Drug Resistance and Treatment Strategies, 6-8 November 2017, Johannesburg, South Africa.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02616029    
Other Study ID Numbers: GS-US-292-1824
2015-002710-74 ( EudraCT Number )
First Submitted: November 24, 2015
First Posted: November 26, 2015
Results First Submitted: October 10, 2019
Results First Posted: November 4, 2019
Last Update Posted: July 23, 2020