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

HIV-1-infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03532425
• Other study ID #: BFTAF vs Atripla
• Status: Terminated
• Phase: Phase 4
• Start date: October 29, 2018
• Est. completion date: September 3, 2020

Study information

• Verified date: November 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• B/F/TAF
B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
• Atripla
Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily
• B/F/TAF Placebo
Tablet taken orally once daily
• Atripla Placebo
Tablet taken orally once daily

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Gilead Sciences, University of British Columbia

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Albumin/Creatinine Ratio (UACR)	change in urine albumin/creatinine ratio (UACR)	Baseline and week 48
Secondary	HIV-1 RNA	Number of participants with HIV-1 RNA < 50 copies/mL	Week 48
Secondary	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.	Baseline and week 4
Secondary	Urine Protein/Creatinine Ratio (UPCR)	change in urine protein/creatinine ratio (UPCR)	Baseline and week 48
Secondary	Estimated Glomerular Filtration Rate (eGFR)	change in estimated glomerular filtration rate (eGFR)	Baseline and week 48
Secondary	Bone Mineral Density (BMD) at the Hip	change in bone mineral density (BMD) at the hip	Baseline and week 48
Secondary	Bone Mineral Density (BMD) at the Spine	change in bone mineral density (BMD) at the spine	Baseline and week 48
Secondary	CD4 Lymphocyte Counts	change in CD4 lymphocyte counts	Baseline and week 48
Secondary	Serum Lipids	change in serum lipids	Baseline and week 48
Secondary	Adverse Events	number of adverse events	Baseline, week 4, week 12, week 24, week 36, and week 48

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