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

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Orlando Immunology Center, Orlando, FL
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Bictegravir - Drug
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

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

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
Photo of Orlando 1Photo of Orlando 2Photo of Orlando 3
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 preview

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.