Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults
![]() |
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: NCT01797445 |
Recruitment Status :
Completed
First Posted : February 22, 2013
Results First Posted : January 8, 2016
Last Update Posted : March 2, 2020
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Conditions |
HIV HIV Infections |
Interventions |
Drug: E/C/F/TAF Drug: E/C/F/TDF Drug: E/C/F/TDF Placebo Drug: E/C/F/TAF Placebo |
Enrollment | 872 |
Recruitment Details | Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 March 2013. The last study visit occurred on 03 October 2018. |
Pre-assignment Details | 1070 participants were screened. |
Arm/Group Title | E/C/F/TAF | E/C/F/TDF |
---|---|---|
![]() |
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks. Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country. |
Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks. Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country. |
Period Title: Double-Blind Phase | ||
Started | 435 | 437 |
Completed | 348 | 348 |
Not Completed | 87 | 89 |
Reason Not Completed | ||
Randomized but Not Treated | 4 | 2 |
Adverse Event | 3 | 0 |
Death | 5 | 4 |
Pregnancy | 0 | 1 |
Lack of Efficacy | 1 | 2 |
Investigator's Discretion | 15 | 17 |
Noncompliance with Study Drug | 5 | 1 |
Protocol Violation | 0 | 1 |
Withdrew Consent | 20 | 35 |
Lost to Follow-up | 34 | 26 |
Period Title: Open-Label Extension Phase | ||
Started | 141 [1] | 119 [2] |
Completed | 140 | 119 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Investigator's Discretion | 1 | 0 |
[1]
207 participants completed the Double-Blind Phase, but did not enter the Open-Label Extension Phase.
[2]
229 participants completed the Double-Blind Phase, but did not enter the Open-Label Extension Phase.
|
Arm/Group Title | E/C/F/TAF | E/C/F/TDF | Total | |
---|---|---|---|---|
![]() |
E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks | E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 431 | 435 | 866 | |
![]() |
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
35 (10.8) | 36 (10.9) | 36 (10.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
Female | 62 | 71 | 133 | |
Male | 369 | 364 | 733 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
American Indian or Alaska Native | 1 | 3 | 4 | |
Asian | 15 | 12 | 27 | |
Black | 129 | 132 | 261 | |
Native Hawaiian or Pacific Islander | 4 | 1 | 5 | |
White | 235 | 243 | 478 | |
Other | 47 | 44 | 91 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
Hispanic or Latino | 107 | 97 | 204 | |
Not Hispanic or Latino | 323 | 336 | 659 | |
Not Permitted | 1 | 1 | 2 | |
Missing | 0 | 1 | 1 | |
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
||||
United States | Number Analyzed | 431 participants | 435 participants | 866 participants |
280 | 282 | 562 | ||
United Kingdom | Number Analyzed | 431 participants | 435 participants | 866 participants |
25 | 31 | 56 | ||
Portugal | Number Analyzed | 431 participants | 435 participants | 866 participants |
21 | 16 | 37 | ||
Canada | Number Analyzed | 431 participants | 435 participants | 866 participants |
19 | 22 | 41 | ||
Netherlands | Number Analyzed | 431 participants | 435 participants | 866 participants |
6 | 8 | 14 | ||
Sweden | Number Analyzed | 431 participants | 435 participants | 866 participants |
8 | 3 | 11 | ||
Dominican Republic | Number Analyzed | 431 participants | 435 participants | 866 participants |
30 | 35 | 65 | ||
Italy | Number Analyzed | 431 participants | 435 participants | 866 participants |
10 | 8 | 18 | ||
Mexico | Number Analyzed | 431 participants | 435 participants | 866 participants |
16 | 12 | 28 | ||
France | Number Analyzed | 431 participants | 435 participants | 866 participants |
16 | 18 | 34 | ||
HIV-1 RNA
Mean (Standard Deviation) Unit of measure: Log10 copies/mL |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
4.53 (0.647) | 4.50 (0.690) | 4.52 (0.669) | ||
HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
≤ 100,000 copies/mL | 339 | 336 | 675 | |
> 100,000 to ≤ 400,000 copies/mL | 68 | 82 | 150 | |
> 400,000 copies/mL | 24 | 17 | 41 | |
CD4 Cell Count
[1] Mean (Standard Deviation) Unit of measure: cells/µL |
||||
Number Analyzed | 430 participants | 435 participants | 865 participants | |
414 (206.8) | 431 (226.8) | 423 (217.1) | ||
[1]
Measure Analysis Population Description: Participants in the Safety Analysis Set with available data were analyzed (E/C/F/TAF: N = 430; E/C/F/TDF: N = 435)
|
||||
CD4 Cell Count Category
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
< 50 cells/μL | 14 | 15 | 29 | |
≥ 50 to < 200 cells/μL | 40 | 49 | 89 | |
≥ 200 to < 350 cells/μL | 115 | 89 | 204 | |
≥ 350 to < 500 cells/μL | 134 | 149 | 283 | |
≥ 500 cells/μL | 127 | 133 | 260 | |
Missing | 1 | 0 | 1 | |
HIV Disease Status
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 431 participants | 435 participants | 866 participants | |
Asymptomatic | 377 | 394 | 771 | |
Symptomatic HIV Infection | 30 | 19 | 49 | |
AIDS | 22 | 19 | 41 | |
Unknown | 2 | 3 | 5 |
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
Name/Title: | Gilead Clinical Study Information Center |
Organization: | Gilead Sciences |
EMail: | GileadClinicalTrials@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01797445 |
Other Study ID Numbers: |
GS-US-292-0111 2013-000102-37 ( EudraCT Number ) |
First Submitted: | February 20, 2013 |
First Posted: | February 22, 2013 |
Results First Submitted: | December 4, 2015 |
Results First Posted: | January 8, 2016 |
Last Update Posted: | March 2, 2020 |