NCT01780506 is a Phase 3 clinical trial of E/C/F/TAF in HIV, sponsored by Gilead Sciences.

Who is sponsoring NCT01780506?

NCT01780506 is sponsored by Gilead Sciences.

What drugs are being tested in NCT01780506?

Interventions in NCT01780506: E/C/F/TAF, E/C/F/TDF, E/C/F/TDF Placebo, E/C/F/TAF Placebo.

What condition does NCT01780506 study?

NCT01780506 studies HIV, HIV Infections.

Is NCT01780506 still recruiting?

NCT01780506 is currently completed. Last updated 19 November 2018.

Are results published for NCT01780506?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-19 · How we verify

NCT01780506

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

Completed Phase 3 Results posted Last updated 19 November 2018

What this trial tests

Phase 3 trial testing E/C/F/TAF in HIV in 872 participants. Completed in 6 September 2017.

Timeline

26 December 2012

Primary endpoint
26 August 2014

6 September 2017

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	872
Start date	26 December 2012
Primary completion	26 August 2014
Estimated completion	6 September 2017
Sites	117 locations across Italy, Japan, Belgium, Austria, United Kingdom, Canada, Puerto Rico, Australia

Drugs / interventions tested

E/C/F/TAF — full drug profile →
E/C/F/TDF — full drug profile →
E/C/F/TDF Placebo
E/C/F/TAF Placebo

Conditions studied

HIV — all drugs for HIV →
HIV Infections — all drugs for HIV Infections →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with HIV 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 With HIV-1 RNA < 50 Copies/mL at Week 48 Primary · 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
E/C/F/TAF	93.1
E/C/F/TDF	92.8

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144 Secondary · Weeks 96 and 144

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Weeks 96 and 144 were 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.

Week 96

Group	Value	95% CI
E/C/F/TAF	89.2
E/C/F/TDF	88.2

Week 144

Group	Value	95% CI
E/C/F/TAF	86.9
E/C/F/TDF	83.1

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144 Secondary · Weeks 48, 96. and 144

The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48, 96, and 144 were 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.

Week 48

Group	Value	95% CI
E/C/F/TAF	86.4
E/C/F/TDF	87.3

Week 96

Group	Value	95% CI
E/C/F/TAF	84.4
E/C/F/TDF	83.6

Week 144

Group	Value	95% CI
E/C/F/TAF	84.6
E/C/F/TDF	80.1

Change From Baseline in CD4+ Cell Count at Week 48 Secondary · Baseline; Week 48

Group	Value	95% CI
E/C/F/TAF	235	± 183.1
E/C/F/TDF	221	± 178.9

Change From Baseline in CD4+ Cell Count at Week 96 Secondary · Baseline; Week 96

Group	Value	95% CI
E/C/F/TAF	285	± 203.0
E/C/F/TDF	271	± 208.1

Change From Baseline in CD4+ Cell Count at Week 144 Secondary · Baseline; Week 144

Group	Value	95% CI
E/C/F/TAF	323	± 213.1
E/C/F/TDF	310	± 207.2

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 Secondary · Baseline; Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.

Group	Value	95% CI
E/C/F/TAF	-0.865	± 3.2532
E/C/F/TDF	-3.200	± 3.1759

Percent Change From Baseline in Hip BMD at Week 96 Secondary · Baseline; Week 96

Hip BMD was assessed by DXA scan.

Group	Value	95% CI
E/C/F/TAF	-0.951	± 3.8633
E/C/F/TDF	-3.515	± 3.9451

Percent Change From Baseline in Hip BMD at Week 144 Secondary · Baseline; Week 144

Hip BMD was assessed by DXA scan.

Group	Value	95% CI
E/C/F/TAF	-0.826	± 4.6786
E/C/F/TDF	-3.475	± 4.1551

Percent Change From Baseline in Spine BMD at Week 48 Secondary · Baseline; Week 48

Spine BMD was assessed by DXA scan.

Group	Value	95% CI
E/C/F/TAF	-1.337	± 3.0715
E/C/F/TDF	-2.956	± 3.3524

Percent Change From Baseline in Spine BMD at Week 96 Secondary · Baseline; Week 96

Spine BMD was assessed by DXA scan.

Group	Value	95% CI
E/C/F/TAF	-0.907	± 4.0039
E/C/F/TDF	-3.053	± 3.9539

Percent Change From Baseline in Spine BMD at Week 144 Secondary · Baseline; Week 144

Spine BMD was assessed by DXA scan.

Group	Value	95% CI
E/C/F/TAF	-0.809	± 4.5041
E/C/F/TDF	-3.023	± 4.3122

Adverse events — posted to ClinicalTrials.gov

Time frame: Double-Blind Phase: Up to a maximum of 194.1 weeks plus 30 days; Open-Label Phase: Up to a maximum of 48.3 weeks plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Double-Blind: E/C/F/TAF

Serious: 73/435 (17%)

Deaths: —

Double-Blind: E/C/F/TDF

Serious: 65/432 (15%)

Deaths: —

Open-Label: E/C/F/TAF to E/C/F/TAF

Serious: 0/90 (0%)

Deaths: —

Open-Label: E/C/F/TDF to E/C/F/TAF

Serious: 1/94 (1%)

Deaths: —

Serious adverse events (147 terms)

Reaction	System	Double-Blind: E/C/F/TAF	Double-Blind: E/C/F/TDF	Open-Label: E/C/F/TAF to E…	Open-Label: E/C/F/TDF to E…
Appendicitis	Infections and infestations	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Meningitis viral	Infections and infestations	—	—	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—
Acute hepatitis C	Infections and infestations	—	—	—	—
Staphylococcal skin infection	Infections and infestations	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—
Dermoid cyst	Congenital, familial and genetic disorders	—	—	—	—
Retinal detachment	Eye disorders	—	—	—	—
Alcoholic pancreatitis	Gastrointestinal disorders	—	—	—	—
Anal fissure	Gastrointestinal disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—

Other adverse events (36 terms — click to expand)

Reaction	System	Double-Blind: E/C/F/TAF	Double-Blind: E/C/F/TDF	Open-Label: E/C/F/TAF to E…	Open-Label: E/C/F/TDF to E…
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Osteopenia	Musculoskeletal and connective tissue disorders	—	—	—	—
Syphilis	Infections and infestations	—	—	—	—
Fatigue	General disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Chlamydial infection	Infections and infestations	—	—	—	—
Gonorrhoea	Infections and infestations	—	—	—	—

Most-reported serious reactions: Appendicitis, Suicidal ideation, Cellulitis, Influenza, Meningitis viral, Uterine leiomyoma, Acute myocardial infarction, Abdominal pain.

Data from ClinicalTrials.gov NCT01780506 adverse events section.

Sponsor's own description

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) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials.
Sax PE, Wohl D, Yin MT, Post F, et al · · 2015 · cited 435× · PMID 25890673 · DOI 10.1016/s0140-6736(15)60616-x
Approved HIV reverse transcriptase inhibitors in the past decade.
Li G, Wang Y, De Clercq E. · · 2022 · cited 71× · PMID 35847492 · DOI 10.1016/j.apsb.2021.11.009
Atherosclerotic Cardiovascular Disease Risk Profile of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate.
Huhn GD, Shamblaw DJ, Baril JG, Hsue PY, et al · · 2020 · cited 39× · PMID 31950070 · DOI 10.1093/ofid/ofz472
Lack of impact of pre-existing T97A HIV-1 integrase mutation on integrase strand transfer inhibitor resistance and treatment outcome.
Abram ME, Abram ME, Ram RR, Margot NA, et al · · 2017 · cited 26× · PMID 28212411 · DOI 10.1371/journal.pone.0172206
Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.
Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, et al · · 2016 · cited 21× · PMID 27742226 · DOI 10.1016/j.ebiom.2016.10.009
Special Issue: Abstract Supplement HIV Glasgow 10-13 November 2024, Glasgow, UK/Virtual.
· 2024 · cited 8× · PMID 39513741 · DOI 10.1002/jia2.26370
In the Crowded HIV Market, There's Room for Innovation.
Clark M, Gohil K. · · 2015 · PMID 25987826

Verify or expand the search:

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Other Gilead Sciences trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01780506 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 19 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/NCT01780506.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01780506

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (147 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of E/C/F/TAF

Other recruiting trials for HIV

Other Gilead Sciences trials

Verify against primary sources