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

• Sponsor: University of Alberta (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03532425
• Collaborator: Gilead Sciences (Industry), University of British Columbia (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Drug: B/F/TAF; Drug: Atripla; Drug: B/F/TAF Placebo; Drug: Atripla Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 29, 2018
• Actual Primary Completion Date: Aug 3, 2020
• Actual Study Completion Date: Sep 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B/F/TAF 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; B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily; Other Names: BIKTARVY® ; Drug: Atripla Placebo; Tablet taken orally once daily
Active Comparator: Atripla 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; Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily; Drug: B/F/TAF Placebo; Tablet taken orally once daily

Outcome Measures

Primary Outcome Measures

1. urine albumin/creatinine ratio (UACR) [baseline and week 48]

   change in urine albumin/creatinine ratio (UACR)

Secondary Outcome Measures

1. HIV-1 RNA [week 48]

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

2. efavirenz (EFV) symptom scores [baseline and week 4]

   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.

3. urine protein/creatinine ratio (UPCR) [baseline and week 48]

   change in urine protein/creatinine ratio (UPCR)

4. estimated glomerular filtration rate (eGFR) [baseline and week 48]

   change in estimated glomerular filtration rate (eGFR)

5. bone mineral density (BMD) at the hip [baseline and week 48]

   change in bone mineral density (BMD) at the hip

6. bone mineral density (BMD) at the spine [baseline and week 48]

   change in bone mineral density (BMD) at the spine

7. CD4 lymphocyte counts [baseline and week 48]

   change in CD4 lymphocyte counts

8. serum lipids [baseline and week 48]

   change in serum lipids

9. adverse events [baseline, week 4, week 12, week 24, week 36, and week 48]

   number of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. HIV-1 seropositive

2. Age > 21 years

3. 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

4. No documented resistance mutations to the components of ATP

5. Any CD4 count, but no active AIDS-defining opportunistic infections or cancers

6. HBsAg+ permitted if plasma HBV DNA is unquantifiable and the patient does not have decompensated liver disease

Exclusion Criteria:

1. Pregnancy, breastfeeding or planned pregnancy in the next 2 years

2. Documented resistance to the components of ATP

3. Active AIDS-defining opportunistic infection or cancer

4. Cancer in past 3 years, except non melanoma skin cancer

5. Active psychotic disease or active depression that may interfere with study participation according investigator discretion

6. Any illness with a life expectancy less than 2 years

7. eGFR < 50 mL/min

8. Urine protein/creatinine > 40 mg/mmoL

9. Patients who the investigator feels are unlikely to commit to the study requirements for any reason

10. Prescription drug therapy for osteoporosis (calcium and/or vitamin D is allowed)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

• University of Alberta
• Gilead Sciences
• University of British Columbia

Investigators

• Principal Investigator: Stephen D Shafran, MD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

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.
• 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.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT03532425
• Other Study ID Numbers: BFTAF vs Atripla
• First Posted: May 22, 2018
• Last Update Posted: Aug 17, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Study Results

No Results Posted as of Aug 17, 2022