Bictegravir for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Progress Estimates

Effectiveness

Safety

Orlando Immunology Center, Orlando, FL

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Bictegravir - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

The primary objectives of this study are to evaluate the efficacy of switching to a bictegravir (BIC) plus lenacapavir (LEN) regimen versus continuing on stable baseline regimen (SBR) in virologically suppressed people with human immunodeficiency virus (PWH) (Phase 2) and to evaluate the efficacy of switching to BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on a SBR in virologically suppressed PWH (Phase 3).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Zinc Gluconate

EBT-101

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Day 1 up to Week 24

Baseline, Week 24

Phase 2: Change From Baseline in CD4 Cell Count at Week 24

Baseline, Week 48

Phase 3: Change From Baseline in CD4 Cell Count at Week 48

Week 24

Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State

Phase 2: PK Parameter: Ctau of BIC and LEN at Steady State

Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State

Week 24

Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (AEs) Through Week 24

Week 48

Phase 3: Percentage of Participants Experiencing Treatment-emergent AEs Through Week 48

Week 24

Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm

Week 48

Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Zinc Gluconate

EBT-101

Trial Design

5 Treatment Groups

Phase 2: Stable Baseline Regimen (SBR)

1 of 5

Phase 3: Stable Baseline Regimen

1 of 5

Phase 3: BIC/LEN Fixed-dose Combination (FDC)

1 of 5

Phase 2: BIC 75 mg + LEN 50 mg

1 of 5

Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg

1 of 5

Active Control

Experimental Treatment

671 Total Participants · 5 Treatment Groups

Primary Treatment: Bictegravir · No Placebo Group · Phase 2 & 3

Phase 3: BIC/LEN Fixed-dose Combination (FDC)

Drug

Experimental Group · 1 Intervention: BIC/LEN FDC · Intervention Types: Drug

Phase 2: BIC 75 mg + LEN 50 mgExperimental Group · 2 Interventions: Bictegravir, Lenacapavir · Intervention Types: Drug, Drug

Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mgExperimental Group · 2 Interventions: Bictegravir, Lenacapavir · Intervention Types: Drug, Drug

Phase 2: Stable Baseline Regimen (SBR)

Drug

ActiveComparator Group · 1 Intervention: Stable Baseline Regimen · Intervention Types: Drug

Phase 3: Stable Baseline Regimen

Drug

ActiveComparator Group · 1 Intervention: Stable Baseline Regimen · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bictegravir

2015

Completed Phase 1

~50

Lenacapavir

2018

Completed Phase 1

~60

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: day 1 up to week 24

Closest Location: Orlando Immunology Center · Orlando, FL

2006First Recorded Clinical Trial

27 TrialsResearching Human Immunodeficiency Virus Type 1 (HIV-1) Infection

98 CompletedClinical Trials

Who is running the clinical trial?

Gilead SciencesLead Sponsor

999 Previous Clinical Trials

656,833 Total Patients Enrolled

64 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection

15,525 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Gilead Study DirectorStudy DirectorGilead Sciences

314 Previous Clinical Trials

175,991 Total Patients Enrolled

35 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection

8,845 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

Plasma HIV-1 RNA levels < 50 copies/mL at screening.

You have no documented or suspected resistance to bictegravir (BIC).

About The Reviewer

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References