Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
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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: NCT02469246 |
Recruitment Status :
Completed
First Posted : June 11, 2015
Results First Posted : June 11, 2018
Last Update Posted : October 25, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
HIV-1 Infection |
Interventions |
Drug: F/TAF Drug: ABC/3TC Drug: ABC/3TC Placebo Drug: F/TAF Placebo Drug: 3rd ARV agent |
Enrollment | 567 |
Recruitment Details | Participants were enrolled at study sites in North America and Europe. The first participant was screened on 29 June 2015. The last study visit occurred on 13 March 2019. |
Pre-assignment Details | 626 participants were screened. |
Arm/Group Title | F/TAF | ABC/3TC |
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Double-Blind Phase: Emtricitabine/tenofovir alafenamide (F/TAF) (200/10 mg) fixed-dose combination (FDC) tablet (with boosted 3rd antiretroviral (ARV) agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + abacavir/lamivudine (ABC/3TC) placebo tablet once daily for 96 weeks, and continued blinded treatment until unblinding. [Allowed boosted 3rd ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)]. Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country. |
Double-Blind Phase: ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks, and continued blinded treatment until unblinding. (Allowed boosted 3rd ARV agents: LPV/r, ATV + RTV, ATV + COBI or ATV/COBI FDC, DRV + RTV, DRV+COBI or DRV/COBI FDC; Allowed unboosted 3rd ARV agents: EFV, RPV, RAL, DTG, MVC, or NVP) Open-Label Extension: After the unblinding visit, in countries where F/TAF FDC was not commercially available, participants (except in certain countries) were given the option to receive the open-label F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country. |
Period Title: Double-Blind Phase | ||
Started | 285 | 282 |
Completed | 218 | 226 |
Not Completed | 67 | 56 |
Reason Not Completed | ||
Randomized and Never Treated | 5 | 6 |
Adverse Event | 12 | 9 |
Death | 2 | 0 |
Lack of Efficacy | 2 | 1 |
Investigator's Discretion | 8 | 8 |
Non-Compliance with Study Drug | 3 | 1 |
Protocol Violation | 1 | 1 |
Withdrew Consent | 25 | 25 |
Lost to Follow-up | 9 | 5 |
Period Title: Open-Label Extension (OLE) | ||
Started | 6 [1] | 5 [1] |
Completed | 6 | 5 |
Not Completed | 0 | 0 |
[1]
Only participants in countries where F/TAF was not commercially available were eligible for the OLE.
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Arm/Group Title | F/TAF | ABC/3TC | Total | |
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F/TAF (200/10 mg) FDC tablet (with boosted 3rd ARV agent) or F/TAF (200/25 mg) FDC tablet (with unboosted 3rd ARV agent) + ABC/3TC placebo tablet once daily for 96 weeks | ABC/3TC (600/300 mg) FDC tablet + F/TAF placebo tablet once daily + allowed 3rd ARV agent for 96 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 280 | 276 | 556 | |
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The Safety Analysis Set included all randomized participants who received at least one dose of study drug. Participants were grouped according to the treatment they actually received.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
51 (9.4) | 51 (9.3) | 51 (9.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
Female | 40 | 61 | 101 | |
Male | 240 | 215 | 455 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
Hispanic or Latino | 16 | 19 | 35 | |
Not Hispanic or Latino | 264 | 257 | 521 | |
Unknown or Not Reported | 0 | 0 | 0 | |
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
American Indian or Alaska Native | 1 | 0 | 1 | |
Asian | 5 | 5 | 10 | |
Black | 64 | 66 | 130 | |
White | 205 | 199 | 404 | |
Other | 5 | 6 | 11 | |
Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 280 participants | 276 participants | 556 participants |
Belgium | 4 | 6 | 10 | |
Canada | 9 | 8 | 17 | |
Denmark | 4 | 3 | 7 | |
France | 18 | 17 | 35 | |
Germany | 20 | 19 | 39 | |
Ireland | 9 | 8 | 17 | |
Italy | 26 | 17 | 43 | |
Spain | 32 | 34 | 66 | |
Sweden | 3 | 4 | 7 | |
United Kingdom | 50 | 59 | 109 | |
United States | 105 | 101 | 206 | |
HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
< 50 copies/mL | 278 | 273 | 551 | |
≥ 50 copies/mL | 2 | 3 | 5 | |
CD4 Cell Count
Mean (Standard Deviation) Unit of measure: cells/µL |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
703 (298.7) | 727 (275.2) | 715 (287.3) | ||
CD4 Cell Count Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
< 50 cells/µL | 0 | 1 | 1 | |
≥ 50 to < 200 cells/µL | 0 | 0 | 0 | |
≥ 200 to < 350 cells/µL | 20 | 16 | 36 | |
≥ 350 to < 500 cells/µL | 56 | 38 | 94 | |
≥ 500 cells/µL | 204 | 221 | 425 | |
HIV Disease Status
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 280 participants | 276 participants | 556 participants | |
Asymptomatic | 201 | 201 | 402 | |
Symptomatic HIV Infection | 31 | 24 | 55 | |
AIDS | 47 | 50 | 97 | |
Unknown | 1 | 1 | 2 |
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: | NCT02469246 |
Other Study ID Numbers: |
GS-US-311-1717 2015-000871-28 ( EudraCT Number ) |
First Submitted: | June 9, 2015 |
First Posted: | June 11, 2015 |
Results First Submitted: | March 29, 2018 |
Results First Posted: | June 11, 2018 |
Last Update Posted: | October 25, 2019 |