NCT03532425

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	B/F/TAF	B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
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
DRUG	Atripla Placebo	Tablet taken orally once daily

Timeline

• Start date: 2018-10-29
• Primary completion: 2020-08-03
• Completion: 2020-09-03
• First posted: 2018-05-22
• Last updated: 2022-12-14
• Results posted: 2022-12-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study