HIVPhase 2/3NCT02276612

Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

A Phase 2/3 study testing E/C/F/TAF in people with HIV, run by Gilead Sciences at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: HIV
What is being tested?: E/C/F/TAF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 7 sitesin 2 countries
Study dates: 3 Dec 2014to 23 Oct 2017
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
Weight ≥ 35 kg (77 lbs.)
Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
CD4+ cell count > 100 cells/μL
No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

Show all 9Show fewer

No evidence of current hepatitis B virus (HBV) infection
No evidence of current hepatitis C virus (HCV) infection
Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Who cannot join

A new AIDS-defining condition diagnosed within the 30 days prior to Screening
Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
Pregnant or lactating subjects
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States4 sites

Study site
Detroit, Michigan
Study site
Memphis, Tennessee
Study site
New York, New York
Study site
Tampa, Florida

Other trials in United States

South Africa3 sites

Study site
Cape Town
Study site
Johannesburg
Study site
Soweto

Other trials in South Africa

About this study

Official title: A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents

Conditions: HIV
Being tested: E/C/F/TAF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E/C/F/TAFDrug
Also called Genvoya®
150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Study groups in NCT02276612
Study group	Role	What they receive
E/C/F/TAF	Experimental	Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks. After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country. Receives: Drug: E/C/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Serious Adverse Events
The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Measured: Up to Week 48
Incidence of Treatment-Emergent Adverse Events
The percentage of participants experiencing any treatment-emergent adverse event was summarized.
Measured: Up to Week 48

Secondary outcomes (6)

Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
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.
Measured: Week 24
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
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.
Measured: Week 48
Change From Baseline in CD4 Cell Count at Week 24
Measured: Baseline; Week 24
Change From Baseline in CD4 Cell Count at Week 48
Measured: Baseline; Week 48
Change From Baseline in CD4 Percentage at Week 24
Measured: Baseline; Week 24
Change From Baseline in CD4 Percentage at Week 48
Measured: Baseline; Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 201423 Oct 2017

First posted28 Oct 2014 (estimated)
Study start3 Dec 2014
Primary completion10 Nov 2016
Study completion23 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02276612
Sponsor's protocol ID: GS-US-292-1515
Other IDs: 2014-002673-11, 2014
Status last verified: Jan 2018
First submitted: 24 Oct 2014
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
ClinicalTrials.gov ID: NCT02276612
Acronym / sponsor ID: GS-US-292-1515
Conditions: HIV
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 3 Dec 2014 (actual)
Primary completion: 10 Nov 2016 (actual)
Study completion: 23 Oct 2017 (actual)
First posted: 28 Oct 2014 (estimated)
Results: Posted 22 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
E/C/F/TAF	Experimental	Drug: E/C/F/TAFTreatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks. After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
Weight ≥ 35 kg (77 lbs.)
Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
CD4+ cell count > 100 cells/μL
No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)

Key exclusion criteria (4 listed)

A new AIDS-defining condition diagnosed within the 30 days prior to Screening
Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
Pregnant or lactating subjects
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E/C/F/TAFAlso: Genvoya®150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food	Drug	E/C/F/TAF

Primary outcome

Incidence of Treatment-Emergent Serious Adverse Events
Time frame: Up to Week 48
The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to Week 48
The percentage of participants experiencing any treatment-emergent adverse event was summarized.

6 secondary outcomes

Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
Time frame: Week 48
Change From Baseline in CD4 Cell Count at Week 24
Time frame: Baseline; Week 24
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline; Week 48
Change From Baseline in CD4 Percentage at Week 24
Time frame: Baseline; Week 24
Change From Baseline in CD4 Percentage at Week 48
Time frame: Baseline; Week 48

Results and safety

Results posted to the registry on 22 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E/C/F/TAF (12 - 17 Years of Age)	50	46
E/C/F/TAF (≥ 18 Years of Age)	10	10

Primary outcome: Incidence of Treatment-Emergent Serious Adverse Events

Time frame: Up to Week 48. Number. Unit: percentage of participants

Measure	E/C/F/TAF (12 - 17 Years of Age) n = 50	E/C/F/TAF (≥ 18 Years of Age) n = 10
Value	4.0	0

Population analysed: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

Primary outcome: Incidence of Treatment-Emergent Adverse Events

Time frame: Up to Week 48. Number. Unit: percentage of participants

Measure	E/C/F/TAF (12 - 17 Years of Age) n = 50	E/C/F/TAF (≥ 18 Years of Age) n = 10
Value	92.0	100.0

Population analysed: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 128 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
E/C/F/TAF (12 - 17 Years of Age)	3 of 50 (6%)	42 of 50 (84%)	1 of 50
E/C/F/TAF (≥ 18 Years of Age)	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing E/C/F/TAF in people with HIV, run by Gilead Sciences at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Serious Adverse Events (time frame: Up to Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.