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

NCT ID: NCT03532425

Last Updated: 2022-12-14

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2020-09-03

Brief Summary

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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.

Detailed Description

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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

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

B/F/TAF

Intervention Type DRUG

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

Atripla Placebo

Intervention Type DRUG

Tablet taken orally once daily

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

Group Type ACTIVE_COMPARATOR

Atripla

Intervention Type DRUG

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

B/F/TAF Placebo

Intervention Type DRUG

Tablet taken orally once daily

Interventions

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B/F/TAF

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

Intervention Type DRUG

Atripla

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

Intervention Type DRUG

B/F/TAF Placebo

Tablet taken orally once daily

Intervention Type DRUG

Atripla Placebo

Tablet taken orally once daily

Intervention Type DRUG

Other Intervention Names

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BIKTARVY®

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen D Shafran, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 28867497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28867499 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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BFTAF vs Atripla

Identifier Type: -

Identifier Source: org_study_id