Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
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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: NCT01818596 |
Recruitment Status :
Completed
First Posted : March 26, 2013
Results First Posted : February 18, 2016
Last Update Posted : March 2, 2020
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
HIV HIV Infections |
Intervention |
Drug: E/C/F/TAF |
Enrollment | 252 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in North America, Australia, Asia, and Europe. The first participant was screened on 27 March 2013. The last study visit occurred on 18 July 2018. |
Pre-assignment Details | 380 participants were screened. |
Arm/Group Title | Cohort 1 (Treatment-experienced) | Cohort 2 (Treatment-naive) |
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Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for up to 240 weeks in antiretroviral treatment (ART)-experienced participants | E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants |
Period Title: Overall Study | ||
Started | 246 | 6 |
Completed | 215 | 6 |
Not Completed | 31 | 0 |
Reason Not Completed | ||
Enrolled but Not Treated | 4 | 0 |
Adverse Event | 7 | 0 |
Death | 3 | 0 |
Investigator's Discretion | 4 | 0 |
Protocol Violation | 1 | 0 |
Withdrew Consent | 5 | 0 |
Lost to Follow-up | 7 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort 1 (Treatment-experienced) | Cohort 2 (Treatment-naive) | Total | |
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 240 weeks in ART-experienced participants | E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for up to 188 weeks in ART-naive participants | Total of all reporting groups | |
Overall Number of Baseline Participants | 242 | 6 | 248 | |
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Safety Analysis Set: participants were enrolled 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 | 242 participants | 6 participants | 248 participants | |
58 (9.9) | 55 (7.1) | 58 (9.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 242 participants | 6 participants | 248 participants | |
Female |
50 20.7%
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0 0.0%
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50 20.2%
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Male |
192 79.3%
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6 100.0%
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198 79.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 242 participants | 6 participants | 248 participants |
Asian |
34 14.0%
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1 16.7%
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35 14.1%
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American Indian or Alaska Native |
1 0.4%
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0 0.0%
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1 0.4%
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Black or African American |
44 18.2%
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3 50.0%
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47 19.0%
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Native Hawaiian or Pacific Islander |
2 0.8%
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0 0.0%
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2 0.8%
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White |
152 62.8%
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2 33.3%
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154 62.1%
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Other |
7 2.9%
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0 0.0%
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7 2.8%
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Not Permitted |
2 0.8%
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0 0.0%
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2 0.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Ethnicity | Number Analyzed | 242 participants | 6 participants | 248 participants |
Hispanic or Latino |
31 12.8%
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1 16.7%
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32 12.9%
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Not Hispanic or Latino |
209 86.4%
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5 83.3%
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214 86.3%
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Not Permitted |
2 0.8%
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0 0.0%
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2 0.8%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 242 participants | 6 participants | 248 participants |
United States |
166 68.6%
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5 83.3%
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171 69.0%
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United Kingdom |
5 2.1%
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0 0.0%
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5 2.0%
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Thailand |
30 12.4%
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1 16.7%
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31 12.5%
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Spain |
13 5.4%
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0 0.0%
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13 5.2%
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Netherlands |
2 0.8%
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0 0.0%
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2 0.8%
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Dominican Republic |
6 2.5%
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0 0.0%
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6 2.4%
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Mexico |
2 0.8%
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0 0.0%
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2 0.8%
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Australia |
12 5.0%
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0 0.0%
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12 4.8%
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France |
6 2.5%
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0 0.0%
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6 2.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
Enrollment in Cohort 2 (treatment-naive) was low, which affects the interpretation of the data.
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 of Results:
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01818596 |
Other Study ID Numbers: |
GS-US-292-0112 2013-000516-25 ( EudraCT Number ) |
First Submitted: | March 22, 2013 |
First Posted: | March 26, 2013 |
Results First Submitted: | December 4, 2015 |
Results First Posted: | February 18, 2016 |
Last Update Posted: | March 2, 2020 |