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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 48

Awards & highlights

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

Side effects data

From 2023 Phase 4 trial • 28 Patients • NCT03797014

18%

Upper respiratory tract infection

Abscess, extremity

Back pain

Headache

Hypertension

Nausea

Rash

Abdominal pain

100%

80%

60%

40%

20%

Study treatment Arm

B/F/TAF

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Placebo to match DTG

2018

Completed Phase 3

~250