NCT03631732

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	50/200/25 mg FDC tablets administered orally once daily without regard to food
DRUG	NRTIs	The following NRTIs will be administered as prescribed until Week 24 without regard to food: abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT)
DRUG	Third Agent	Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. : * Non-nucleoside reverse transcriptase inhibitors (NNRTIs) * delavirdine (DLV) * efavirenz (EFV) * nevirapine (NVP) * rilpivirine (RPV) * doravirine (DOR) * Integrase inhibitors * dolutegravir (DTG) * elvitegravir (EVG) * raltegravir (RAL) * Protease inhibitors (PIs) * atazanavir (ATV) * darunavir (DRV) * lopinavir (LPV) * nelfinavir NFV) * saquinavir (SQV) * tipranavir (TPV) * Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC)

Timeline

• Start date: 2018-08-28
• Primary completion: 2019-08-12
• Completion: 2020-08-19
• First posted: 2018-08-15
• Last updated: 2021-09-05
• Results posted: 2020-08-27

Locations

82 sites across 1 country: United States

Regulatory

• FDA-regulated drug study