Substudy-01: GS-5894 for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
B/F/TAF - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Master protocol: The goal of this master (umbrella) clinical trial study is to learn how novel antiretrovirals affect the HIV-1 infection in people living with HIV (PWH). The safety and how well the study drugs are tolerated will be determined by using physical exams, laboratory tests, and any symptoms or problems a participant might experience during the study. Substudy-01 (GS-US-544-5905-01) will evaluate GS-5894 in people with HIV PWH.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Day 1 Predose up to Day 39

Baseline; Day 11
15S RNA
Baseline; Day 8
All Substudies: Change From Baseline in Plasma HIV-1 RNA (log10 copies/mL) at Day 8
Day 11
Substudy-01: PK Parameter: Ct of GS-5894
Substudy-01: Pharmacokinetic (PK) Parameter: Cmax of GS-5894
Day 39
Substudy-01: PK Parameter of: AUC of GS-5894
Day 11
Plasma Exchange
Day 39
All Substudies: Percentage of Participants Experiencing Adverse Events (AEs)
All Substudies: Percentage of Participants Experiencing Graded Laboratory Abnormalities
Up to Day 11
All Substudies: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level
Substudy-01: Percentage of Participants with Emergence of Viral Resistance to Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Trial Safety

Safety Progress

1 of 3

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

Trial Design

1 Treatment Group

Substudy-01: GS-5894
1 of 1
Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: Substudy-01: GS-5894 · No Placebo Group · Phase 1

Substudy-01: GS-5894Experimental Group · 3 Interventions: B/F/TAF, Standard of Care, GS-5894 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 3
~4440
Standard of Care
2017
Completed Phase 4
~9880

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 predose up to day 39

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,006 Previous Clinical Trials
653,279 Total Patients Enrolled
65 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
16,189 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Gilead Study DirectorStudy DirectorGilead Sciences
316 Previous Clinical Trials
178,855 Total Patients Enrolled
36 Trials studying Human Immunodeficiency Virus Type 1 (HIV-1) Infection
9,507 Patients Enrolled for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a CD4 cell count of at least 200 cells/mm^3 at screening.
You have adequate renal function.
You are willing to initiate a standard of care (SOC) ART regimen on Day 11 or upon early termination (ET) as stated in the master protocol.
You are willing and able to comply with meal requirements on dosing days.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 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.