Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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| ClinicalTrials.gov Identifier: NCT01497899 |
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Recruitment Status :
Completed
First Posted : December 23, 2011
Results First Posted : January 8, 2016
Last Update Posted : November 19, 2018
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Conditions |
Acquired Immunodeficiency Syndrome HIV Infections |
| Interventions |
Drug: E/C/F/TDF Drug: E/C/F/TAF Placebo Drug: E/C/F/TAF Drug: E/C/F/TDF Placebo |
| Enrollment | 279 |
Participant Flow
| Recruitment Details | Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 28 December 2011. The last study visit occurred on 22 August 2016. |
| Pre-assignment Details | 232 participants were screened for the Double-Blind Phase. 108 participants from other Gilead-sponsored Study GS-US-299-0102 joined the Open-Label Extension Phase. |
| Arm/Group Title | E/C/F/TAF | E/C/F/TDF | D/C/F/TAF to Open-Label E/C/F/TAF | DRV+COBI+TVD to Open-Label E/C/F/TAF |
|---|---|---|---|---|
 Arm/Group Description |
Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily |
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 48 weeks Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily |
Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. | Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. |
| Period Title: Double-Blind Phase | ||||
| Started | 113 | 58 | 0 | 0 |
| Completed | 107 | 53 | 0 | 0 |
| Not Completed | 6 | 5 | 0 | 0 |
| Reason Not Completed | ||||
| Randomized but not Treated | 1 | 0 | 0 | 0 |
| Adverse Event | 1 | 0 | 0 | 0 |
| Lack of Efficacy | 0 | 1 | 0 | 0 |
| Investigator's Discretion | 1 | 0 | 0 | 0 |
| Withdrew Consent | 0 | 1 | 0 | 0 |
| Lost to Follow-up | 3 | 2 | 0 | 0 |
| Subject Non-Compliance | 0 | 1 | 0 | 0 |
| Period Title: Open-Label Extension Phase | ||||
| Started | 105 [1] | 53 | 70 [2] | 38 [2] |
| Completed | 86 | 46 | 61 | 33 |
| Not Completed | 19 | 7 | 9 | 5 |
| Reason Not Completed | ||||
| Adverse Event | 1 | 0 | 0 | 0 |
| Death | 1 | 0 | 0 | 0 |
| Withdrew Consent | 8 | 3 | 2 | 0 |
| Pregnancy | 0 | 1 | 1 | 0 |
| Protocol Violation | 0 | 0 | 1 | 0 |
| Lost to Follow-up | 9 | 3 | 5 | 5 |
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[1]
2 participants completed the Double-Blind Phase, but did not continue in the Open-Label Extension.
[2]
Participants enrolled from other Gilead-sponsored Study GS-US-299-0102.
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Baseline Characteristics
| Arm/Group Title | E/C/F/TAF | E/C/F/TDF | D/C/F/TAF to Open-Label E/C/F/TAF | DRV+COBI+TVD to Open-Label E/C/F/TAF | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily |
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 48 weeks Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily |
Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. | Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 112 | 58 | 70 | 38 | 278 | |
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Baseline Analysis Population Description |
E/C/F/TAF and E/C/F/TDF arms: participants who were randomized to the Double-Blind Phase and received at least 1 dose of study drug.
D/C/F/TAF to E/C/F/TAF and DRV+COBI+TVD to E/C/F/TAF arms: participants who enrolled from Gilead-sponsored Study GS-US-299-0102 in the Open-Label Extension Phase and received at least 1 dose of open-label E/C/F/TAF
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 112 participants | 58 participants | 70 participants | 38 participants | 278 participants | |
| 35 (11.3) | 37 (10.6) | 36 (11.2) | 37 (10.7) | 36 (11.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 112 participants | 58 participants | 70 participants | 38 participants | 278 participants | |
| Female |
4 3.6%
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1 1.7%
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3 4.3%
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3 7.9%
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11 4.0%
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| Male |
108 96.4%
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57 98.3%
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67 95.7%
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35 92.1%
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267 96.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
There were no limitations affecting the analysis or results.
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: | Clinical Trial Disclosures |
| Organization: | Gilead Sciences |
| EMail: | ClinicalTrialDisclosures@gilead.com |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01497899 |
| Other Study ID Numbers: |
GS-US-292-0102 |
| First Submitted: | December 14, 2011 |
| First Posted: | December 23, 2011 |
| Results First Submitted: | December 4, 2015 |
| Results First Posted: | January 8, 2016 |
| Last Update Posted: | November 19, 2018 |