18 and older, any sex, with HIV-1 or HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24Primary· Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Group
Value
95% CI
Cohort 2: E/C/F/TAF+DRV
96.6
Cohort 2: Stay on Baseline Regimen (SBR)
91.3
Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48Secondary· Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Group
Value
95% CI
Cohort 2: E/C/F/TAF+DRV
94.4
Cohort 2: Stay on Baseline Regimen (SBR)
76.1
Change From Baseline in CD4+ Cell Count at Week 24Secondary· Baseline; Week 24
Group
Value
95% CI
Cohort 2: E/C/F/TAF+DRV
23
± 155.2
Cohort 2: Stay on Baseline Regimen (SBR)
12
± 100.9
Change From Baseline in CD4+ Cell Count at Week 48Secondary· Baseline; Week 48
Group
Value
95% CI
Cohort 2: E/C/F/TAF+DRV
5
± 162.6
Cohort 2: Stay on Baseline Regimen (SBR)
41
± 104.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24.
This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03092206 — Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medica
· Phase 1
· completed
NCT02707601 — Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who
· Phase 3
· completed
NCT02652624 — Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Supp
· Phase 3
· completed
NCT02616783 — Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofo
· Phase 3
· completed
NCT02616029 — Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combin
· Phase 3
· completed
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Other Gilead Sciences trials
Trials by the same sponsor.
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· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 16 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01968551.