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Study to Evaluate Switching F...

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

Last Updated: 2021-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2020-08-19

Brief Summary

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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.

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Detailed Description

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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

NONE

Study Groups

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B/F/TAF

Participants will receive B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.

Group Type EXPERIMENTAL

B/F/TAF

Intervention Type DRUG

50/200/25 mg FDC tablets administered orally once daily without regard to food

Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF

Participants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.

Group Type ACTIVE_COMPARATOR

B/F/TAF

Intervention Type DRUG

50/200/25 mg FDC tablets administered orally once daily without regard to food

NRTIs

Intervention Type DRUG

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)

Third Agent

Intervention Type DRUG

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)

Interventions

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B/F/TAF

50/200/25 mg FDC tablets administered orally once daily without regard to food

Intervention Type DRUG

NRTIs

Intervention Type DRUG

Third Agent

Intervention Type DRUG

Other Intervention Names

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Biktarvy®

Eligibility Criteria

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Inclusion Criteria

* Self-describes as Black, African American, or mixed race, including Black
* Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months
* Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc
* If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded
* Baseline regimens containing investigational drugs or \> 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI)
* Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving \<50 copies/mL while on an INSTI-containing regimen)
* History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded
* Documented plasma HIV-1 RNA \< 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit
* HIV-1 RNA levels \< 50 copies/mL at Screening
* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance

Exclusion Criteria

* History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT
* No desire to switch from current ARVs
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
* Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
* Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed
* Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance
* Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1
* Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements
* Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient
* Females who are pregnant (as confirmed by positive serum pregnancy test)
* Females who are breastfeeding
* Acute hepatitis in the 30 days prior to randomization
* Active tuberculosis infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Alabama Medical Group, PC

Mobile, Alabama, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Ruane Clinical Research Group Inc.

Los Angeles, California, United States

Site Status

Mills Clinical Research

Los Angeles, California, United States

Site Status

Highland Hospital- Alameda Health System

Oakland, California, United States

Site Status

Kaiser Permanente

Oakland, California, United States

Site Status

One Community Health

Sacramento, California, United States

Site Status

Kaiser Permanente

Sacramento, California, United States

Site Status