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Antiretroviral Therapy

B/F/TAF vs DTG + F/TDF for HIV-1 and Hepatitis B Co-Infection (Alliance Trial)

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 96
Awards & highlights

Alliance Trial Summary

This trial will compare the effectiveness of two different drug combinations for treating HIV and hepatitis B in adults who have not previously received treatment for either virus.

Who is the study for?
This trial is for adults who have both HIV-1 and Hepatitis B but haven't started treatment yet. They need a certain level of HIV in their blood and must be sensitive to specific drugs. People with severe liver issues, high levels of HBV DNA, recent serious infections, or those using substances that could affect the study can't join.Check my eligibility
What is being tested?
The study compares two treatments for HIV-1 and Hepatitis B co-infection: one group receives a combo pill (B/F/TAF), while the other gets Dolutegravir plus another combo (F/TDF). The goal is to see which treatment works better for people who are new to HIV therapy.See study design
What are the potential side effects?
Possible side effects include digestive problems, headaches, fatigue, skin reactions, and changes in liver enzymes. There might also be risks related to drug interactions between medications used for treating HIV and Hepatitis B.

Alliance Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)
Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)
Secondary outcome measures
Change From Baseline in CD4 Cell Count at Week 48
Change From Baseline in CD4 Cell Count at Week 96
Change From Baseline in CD4 Percentage at Week 48
+7 more

Side effects data

From 2023 Phase 4 trial • 28 Patients • NCT03797014
18%
Upper respiratory tract infection
7%
Abdominal pain
7%
Abscess, extremity
7%
Back pain
7%
Headache
7%
Hypertension
7%
Nausea
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
B/F/TAF

Alliance Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Open-label Extension Phase: B/F/TAFExperimental Treatment1 Intervention
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first.
Group II: B/F/TAFExperimental Treatment3 Interventions
B/F/TAF + placebo to match DTG + placebo to match F/TDF for 96 weeks.
Group III: DTG+F/TDFActive Control3 Interventions
DTG + F/TDF + placebo to match B/F/TAF for 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 4
~4900
Placebo to match DTG
2018
Completed Phase 3
~250
Placebo to match F/TDF
2018
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,509 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,503 Total Patients Enrolled

Media Library

Bictegravir/Emtricitabine/Tenofovir Alafenamide (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03547908 — Phase 3
HIV-1 and Hepatitis B Co-Infection Research Study Groups: B/F/TAF, DTG+F/TDF, Open-label Extension Phase: B/F/TAF
HIV-1 and Hepatitis B Co-Infection Clinical Trial 2023: Bictegravir/Emtricitabine/Tenofovir Alafenamide Highlights & Side Effects. Trial Name: NCT03547908 — Phase 3
Bictegravir/Emtricitabine/Tenofovir Alafenamide (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03547908 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still looking for volunteers for this research project?

"No, the trial is not currently looking for candidates. However, this may change in the future as the last update on the posting was September 19th, 2022. There are 318 other trials that patients can sign up for at this time."

Answered by AI

Will there be any negative health effects for patients that use B/F/TAF?

"B/F/TAF received a safety score of 3 from our team because it is a Phase 3 trial. This suggests that not only is there some data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

How many research facilities are overseeing this project?

"4 active clinical trial sites are enrolling patients for this study. If you wish to participate, it would be best to choose a location near you from the following cities: Houston, West Palm Beach, Fort Pierce and 4 other locations."

Answered by AI

What are some of the most well-known afflictions that B/F/TAF is regularly used to help patients with?

"B/F/TAF is frequently used as an anti-retroviral agent, but it can also be part of a treatment plan for other conditions like hepatitis b and chronic not requiring cyp3a inhibitors."

Answered by AI

Are there any restrictions on the number of participants for this trial?

"Unfortunately, this particular trial is not presently looking for candidates. The trial was originally posted on 5/30/2018 but the most recent update was on 9/19/2022. There are currently 193 clinical trials actively searching for patients with hiv-1/hbv co-infection and 125 trials for B/F/TAF enrolling patients if you are interested in other research studies."

Answered by AI

Are there other drugs in development that work similarly to B/F/TAF?

"University of Zurich first studied B/F/TAF in 2002 and, to date, 452 completed studies exist with 125 live studies. The majority of these ongoing studies are based in Houston, Texas."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
2018. "Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03547908.
~36 spots leftby Apr 2025
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