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

NCT03532425 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: BFTAF vs Atripla
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Urine Albumin/Creatinine Ratio (UACR)

  change in urine albumin/creatinine ratio (UACR)

  Baseline and week 48

Secondary Outcomes (9)

• HIV-1 RNA

  Week 48

• Efavirenz (EFV) Symptom Scores

  Baseline and week 4

• Urine Protein/Creatinine Ratio (UPCR)

  Baseline and week 48

• Estimated Glomerular Filtration Rate (eGFR)

  Baseline and week 48

• Bone Mineral Density (BMD) at the Hip

  Baseline and week 48

Study Arms (2)

B/F/TAF

EXPERIMENTAL

B/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

Drug: B/F/TAF; Drug: Atripla Placebo

Atripla

ACTIVE COMPARATOR

Atripla + 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

Drug: Atripla; Drug: B/F/TAF Placebo

Interventions

B/F/TAF DRUG

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

Also known as: BIKTARVY®

B/F/TAF

Atripla DRUG

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

Atripla

B/F/TAF Placebo DRUG

Tablet taken orally once daily

Atripla

Atripla Placebo DRUG

Tablet taken orally once daily

B/F/TAF

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Gilead Sciences: collaborator
• University of British Columbia: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 28867497 BACKGROUND

• 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.

  PMID: 28867499 BACKGROUND

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Stephen D. Shafran
• Organization: University of Alberta

sshafran@ualberta.ca

780-407-6945

Study Officials

• Stephen D Shafran, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: October 29, 2018
• Primary Completion: August 3, 2020
• Study Completion: September 3, 2020
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)