Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
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ClinicalTrials.gov Identifier: NCT02345226 |
Recruitment Status :
Completed
First Posted : January 26, 2015
Results First Posted : October 19, 2017
Last Update Posted : January 2, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
HIV-1 Infection |
Interventions |
Drug: FTC/RPV/TAF Drug: EFV/FTC/TDF Placebo Drug: EFV/FTC/TDF Drug: FTC/RPV/TAF Placebo |
Enrollment | 881 |
Recruitment Details | Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 02 January 2019. |
Pre-assignment Details | 974 participants were screened. |
Arm/Group Title | FTC/RPV/TAF | EFV/FTC/TDF |
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Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) placebo tablet orally once daily for up to 96 weeks. Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first. |
Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks. Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first. |
Period Title: Double-Blind Phase | ||
Started | 440 | 441 |
Completed | 371 | 370 |
Not Completed | 69 | 71 |
Reason Not Completed | ||
Adverse Event | 5 | 6 |
Death | 3 | 0 |
Pregnancy | 0 | 1 |
Lack of Efficacy | 1 | 0 |
Investigator's Discretion | 4 | 3 |
Non-Compliance with Study Drug | 1 | 2 |
Withdrew Consent | 41 | 39 |
Lost to Follow-up | 12 | 16 |
Randomized but Never Treated | 2 | 4 |
Period Title: Open-Label Extension Phase | ||
Started | 25 [1] | 21 [2] |
Completed | 25 | 20 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Lost to Follow-up | 0 | 1 |
[1]
346 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
[2]
349 participants completed the Double-Blind Phase, but did not enter Open-Label Extension Phase.
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Arm/Group Title | FTC/RPV/TAF | EFV/FTC/TDF | Total | |
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FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks. | EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 438 | 437 | 875 | |
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The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
48 (9.8) | 47 (10.5) | 48 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
Female | 373 | 390 | 763 | |
Male | 65 | 47 | 112 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
American Indian or Alaska Native | 3 | 2 | 5 | |
Asian | 9 | 8 | 17 | |
Black | 118 | 120 | 238 | |
Native Hawaiian or Pacific Islander | 1 | 0 | 1 | |
White | 291 | 292 | 583 | |
Not Permitted | 6 | 3 | 9 | |
Other | 10 | 12 | 22 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
Hispanic or Latino | 79 | 78 | 157 | |
Not Hispanic or Latino | 358 | 359 | 717 | |
Not Permitted | 1 | 0 | 1 | |
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 438 participants | 437 participants | 875 participants |
Canada | 20 | 24 | 44 | |
Belgium | 3 | 4 | 7 | |
United States | 351 | 345 | 696 | |
United Kingdom | 4 | 11 | 15 | |
France | 7 | 6 | 13 | |
Switzerland | 6 | 5 | 11 | |
Germany | 33 | 27 | 60 | |
Spain | 14 | 15 | 29 | |
HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
< 50 copies/mL | 430 | 432 | 862 | |
≥ 50 copies/mL | 8 | 5 | 13 | |
CD4 Cell Count
Mean (Standard Deviation) Unit of measure: cells/µL |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
711 (292.3) | 688 (263.5) | 700 (278.4) | ||
CD4 Cell Count Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 438 participants | 437 participants | 875 participants | |
≥ 50 to < 200 cells/µL | 2 | 5 | 7 | |
≥ 200 to < 350 cells/µL | 41 | 26 | 67 | |
≥ 350 to < 500 cells/µL | 63 | 74 | 137 | |
≥ 500 cells/ µL | 332 | 332 | 664 |
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 |
Phone: | 1-833-445-3230 (GILEAD-0) |
EMail: | GileadClinicalTrials@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02345226 |
Other Study ID Numbers: |
GS-US-366-1160 2014-004779-21 ( EudraCT Number ) |
First Submitted: | January 19, 2015 |
First Posted: | January 26, 2015 |
Results First Submitted: | September 21, 2017 |
Results First Posted: | October 19, 2017 |
Last Update Posted: | January 2, 2020 |