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HIV-1-infectionPhase 4NCT03532425

B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults

A Phase 4 study testing B/F/TAF and Atripla in people with HIV-1-infection, run by University of Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
B/F/TAF and Atripla
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteCanada
Study dates
29 Oct 2018to 3 Sep 2020
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV-1 seropositive
  • Age > 21 years
  • Receiving ATP > 2 years as their only ART, with HIV-1 RNA < 50 copies/mL at screening and all HIV-1 RNA tests < 100 copies/mL in the past 18 months
  • No documented resistance mutations to the components of ATP
  • Any CD4 count, but no active AIDS-defining opportunistic infections or cancers
  • HBsAg+ permitted if plasma HBV DNA is unquantifiable and the patient does not have decompensated liver disease

Who cannot join

  • Pregnancy, breastfeeding or planned pregnancy in the next 2 years
  • Documented resistance to the components of ATP
  • Active AIDS-defining opportunistic infection or cancer
  • Cancer in past 3 years, except non melanoma skin cancer
  • Active psychotic disease or active depression that may interfere with study participation according investigator discretion
  • Any illness with a life expectancy less than 2 years
Show all 10Show fewer
  • eGFR < 50 mL/min
  • Urine protein/creatinine > 40 mg/mmoL
  • Patients who the investigator feels are unlikely to commit to the study requirements for any reason
  • Prescription drug therapy for osteoporosis (calcium and/or vitamin D is allowed)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults

Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.

Read the detailed description

B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that contains neither TDF nor EFV. This study is looking at whether changing people to this new drug treatment will continue to suppress their HIV and have fewer side effects.

Conditions
HIV-1-infection
Being tested
B/F/TAF, Atripla, B/F/TAF Placebo, Atripla Placebo

What participants receive

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

  • B/F/TAFDrug

    Also called BIKTARVY®

    B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily

  • AtriplaDrug

    Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily

  • B/F/TAF PlaceboDrug

    Tablet taken orally once daily

  • Atripla PlaceboDrug

    Tablet taken orally once daily

Study groups in NCT03532425
Study groupRoleWhat they receive
B/F/TAFExperimentalB/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
Receives: Drug: B/F/TAF; Drug: Atripla Placebo
AtriplaActive comparatorAtripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
Receives: Drug: Atripla; Drug: B/F/TAF Placebo

What is being measured

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

  1. Urine Albumin/Creatinine Ratio (UACR)

    change in urine albumin/creatinine ratio (UACR)

    Measured: Baseline and week 48

Secondary outcomes (9)

  1. HIV-1 RNA

    Number of participants with HIV-1 RNA < 50 copies/mL

    Measured: Week 48

  2. Efavirenz (EFV) Symptom Scores

    change in EFV symptom scores from Pittsburgh Sleep Quality Questionnaire (PSQI) global score. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI global score has a possible range of 0-21. Higher scores represent worse sleep quality.

    Measured: Baseline and week 4

  3. Urine Protein/Creatinine Ratio (UPCR)

    change in urine protein/creatinine ratio (UPCR)

    Measured: Baseline and week 48

  4. Estimated Glomerular Filtration Rate (eGFR)

    change in estimated glomerular filtration rate (eGFR)

    Measured: Baseline and week 48

  5. Bone Mineral Density (BMD) at the Hip

    change in bone mineral density (BMD) at the hip

    Measured: Baseline and week 48

  6. Bone Mineral Density (BMD) at the Spine

    change in bone mineral density (BMD) at the spine

    Measured: Baseline and week 48

  7. CD4 Lymphocyte Counts

    change in CD4 lymphocyte counts

    Measured: Baseline and week 48

  8. Serum Lipids

    change in serum lipids

    Measured: Baseline and week 48

  9. Adverse Events

    number of adverse events

    Measured: Baseline, week 4, week 12, week 24, week 36, and week 48

Timeline

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

  1. First posted22 May 2018
  2. Study start29 Oct 2018
  3. Primary completion3 Aug 2020
  4. Study completion3 Sep 2020

Why it stopped: Difficulties enrolling participants

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532425
Sponsor's protocol ID
BFTAF vs Atripla
Status last verified
Nov 2022
First submitted
9 May 2018
Last updated
14 Dec 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.

    PubMed 28867497

  • Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.

    PubMed 28867499

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing B/F/TAF and Atripla in people with HIV-1-infection, run by University of Alberta at 1 site in Canada.

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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Dec 2022). 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?

Urine Albumin/Creatinine Ratio (UACR) (time frame: Baseline and week 48). 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 NCT03532425, which also lists 2 linked publications.

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 14 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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