Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years
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ClinicalTrials.gov Identifier: NCT02616783 |
Recruitment Status :
Completed
First Posted : November 30, 2015
Results First Posted : February 19, 2019
Last Update Posted : March 4, 2020
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV-1 Infection |
Interventions |
Drug: E/C/F/TAF Drug: TDF Drug: FTC Drug: FTC/TDF Drug: 3TC Drug: Third agent |
Enrollment | 167 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in Europe. The first participant was screened on 22 December 2015. The last study visit occurred on 21 March 2018. |
Pre-assignment Details | 214 participants were screened. |
Arm/Group Title | E/C/F/TAF | Stay on Baseline Regimen |
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Participants switched from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily for 48 weeks. | Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks. |
Period Title: Overall Study | ||
Started | 111 | 56 |
Completed | 105 | 54 |
Not Completed | 6 | 2 |
Reason Not Completed | ||
Randomized but Not Treated | 1 | 0 |
Adverse Event | 1 | 0 |
Death | 1 | 0 |
Non-Compliance with Study Drug | 1 | 0 |
Protocol Violation | 1 | 1 |
Withdrew Consent | 1 | 1 |
Baseline Characteristics
Arm/Group Title | E/C/F/TAF | Stay on Baseline Regimen | Total | |
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Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks. | Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 110 | 56 | 166 | |
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Safety Analysis Set included all participants who were randomized into the study 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 | 110 participants | 56 participants | 166 participants | |
65 (4.6) | 66 (4.9) | 66 (4.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
Female |
14 12.7%
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5 8.9%
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19 11.4%
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Male |
96 87.3%
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51 91.1%
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147 88.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
Hispanic or Latino |
16 14.5%
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8 14.3%
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24 14.5%
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Not Hispanic or Latino |
88 80.0%
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42 75.0%
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130 78.3%
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Unknown or Not Reported |
6 5.5%
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6 10.7%
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12 7.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
American Indian or Alaska Native |
0 0.0%
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1 1.8%
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1 0.6%
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Black or African American |
2 1.8%
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2 3.6%
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4 2.4%
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White |
103 93.6%
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49 87.5%
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152 91.6%
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Not Permitted |
5 4.5%
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4 7.1%
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9 5.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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Belgium | Number Analyzed | 110 participants | 56 participants | 166 participants |
8 7.3%
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1 1.8%
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9 5.4%
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Italy | Number Analyzed | 110 participants | 56 participants | 166 participants |
36 32.7%
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15 26.8%
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51 30.7%
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United Kingdom | Number Analyzed | 110 participants | 56 participants | 166 participants |
8 7.3%
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3 5.4%
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11 6.6%
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France | Number Analyzed | 110 participants | 56 participants | 166 participants |
29 26.4%
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23 41.1%
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52 31.3%
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Spain | Number Analyzed | 110 participants | 56 participants | 166 participants |
29 26.4%
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14 25.0%
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43 25.9%
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HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
< 50 copies/mL |
109 99.1%
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56 100.0%
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165 99.4%
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≥ 50 copies/mL |
1 0.9%
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0 0.0%
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1 0.6%
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CD4+ Cell Count
Mean (Standard Deviation) Unit of measure: cells/µL |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
649 (255.6) | 676 (316.5) | 658 (277.0) | ||
CD4+ Cell Count Category
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 56 participants | 166 participants | |
≥ 50 to < 200 cells/µL |
0 0.0%
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2 3.6%
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2 1.2%
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≥ 200 to < 350 cells/µL |
12 10.9%
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8 14.3%
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20 12.0%
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≥ 350 to < 500 cells/µL |
18 16.4%
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7 12.5%
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25 15.1%
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≥ 500 cells/µL |
80 72.7%
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39 69.6%
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119 71.7%
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Spine Bone Mineral Density (BMD)
[1] Mean (Standard Deviation) Unit of measure: G/cm^2 |
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Number Analyzed | 109 participants | 55 participants | 164 participants | |
1.036 (0.1886) | 1.052 (0.1789) | 1.042 (0.1850) | ||
[1]
Measure Analysis Population Description: The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations.
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Hip BMD
[1] Mean (Standard Deviation) Unit of measure: G/cm^2 |
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Number Analyzed | 109 participants | 55 participants | 164 participants | |
0.922 (0.1332) | 0.927 (0.1346) | 0.924 (0.1332) | ||
[1]
Measure Analysis Population Description: The Hip DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening hip BMD values, and did not have any major protocol violations.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Gilead Clinical Study Information Center |
Organization: | Gilead Sciences |
Phone: | 1-833-445-3230 (GILEAD-0) |
EMail: | GileadClinicalTrials@gilead.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02616783 |
Other Study ID Numbers: |
GS-US-292-1826 2015-002712-32 ( EudraCT Number ) |
First Submitted: | November 23, 2015 |
First Posted: | November 30, 2015 |
Results First Submitted: | January 31, 2019 |
Results First Posted: | February 19, 2019 |
Last Update Posted: | March 4, 2020 |