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Antiretroviral

Novel Antiretroviral Therapy for HIV

Phase 1
Recruiting
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), or injectable rilpivirine (RPV) is exclusionary).
Have adequate renal function (estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73m^2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up substudy-01: first dose date up to day 39; substudy-02: first dose date up to day 60; substudy-03 first dose date up to day 25
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will evaluate safety & effectiveness of drugs to fight HIV in people living with it. Tests, physical exams & symptoms tracked to ensure safety & effectiveness.

Who is the study for?
This trial is for adults with HIV-1 who have a certain level of viral load, CD4 cell count above 200 cells/mm^3, and good kidney function. They should be new to the drug class being tested or haven't taken any antiretrovirals in the last 12 weeks. People can't join if they've had AIDS-defining conditions, resistance to major ARV classes, hepatitis B or C infections, significant liver issues, are pregnant/breastfeeding, need prohibited medications or have serious health problems.Check my eligibility
What is being tested?
The study tests novel antiretrovirals GS-5894 and GS-1720 against standard HIV treatments in two substudies. Participants will start on a standard care regimen after Day 11. The aim is to see how these new drugs affect HIV-1 levels compared to usual treatments.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to antiretroviral therapy such as nausea, headaches, fatigue, and possible drug-specific effects which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not taken any HIV drugs or only those not being tested in this study, and none in the last 12 weeks.
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My kidney function is good, with an eGFR of 70 or higher.
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I am willing to start the recommended HIV treatment on Day 11 or if needed sooner.
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I have not taken any HIV drugs recently, including for prevention.
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My kidney function is good, with an eGFR of 70 mL/min/1.73 m^2 or higher.
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I am willing to start a specific HIV treatment on Day 11.
Select...
I am willing to start standard HIV treatment on Day 11.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~substudy-01: first dose date up to day 39; substudy-02: first dose date up to day 60; substudy-03 first dose date up to day 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and substudy-01: first dose date up to day 39; substudy-02: first dose date up to day 60; substudy-03 first dose date up to day 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
15S RNA
Secondary outcome measures
All Substudies: Change From Baseline in Plasma HIV-1 RNA (log10 copies/mL) at Day 8
Plasma Exchange
All Substudies: Percentage of Participants Experiencing Adverse Events (AEs)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Substudy-03: GS-6212Experimental Treatment3 Interventions
Participants will receive GS-6212. After assessment on Day 11 or upon ET, participants will initiate a regimen of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY)), or an alternative SOC ART regimen up to Day 25. Approximately 5 cohorts may enroll. Participants will be enrolled in Cohort 1 initially and then dosing in subsequent cohorts will proceed after safety review team (SRT) review of emerging data.
Group II: Substudy-02: GS-1720Experimental Treatment3 Interventions
Participants will receive GS-1720. After assessments on Day 11 or upon ET, participants will initiate a regimen of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY)), or an alternative SOC ART regimen up to Day 60. SOC ART regimen, example INSTIs: DTG/ABC/3TC or DTG/3TC Approximately 5 cohorts may enroll. Participants will be enrolled in Cohort 1 initially and then dosing in subsequent cohorts will proceed after safety review team (SRT) review of emerging data.
Group III: Substudy-01: GS-5894Experimental Treatment3 Interventions
Participants will receive GS-5894. After assessments on Day 11 or upon early termination (ET), participants will initiate a regimen of Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY)), or other non-nonnucleoside reverse transcriptase inhibitor (NNRTI) based standard of care (SOC) antiretroviral therapy (ART) regimen up to Day 39. Non-NNRTI SOC ART regimen may include: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC), (ABC/DTG/3TC) DTG plus (tenofovir alafenamide fumarate (TAF) or tenofovir disoproxil fumarate (TDF) plus (emtricitabine (FTC) or 3TC) Approximately 5 cohorts may enroll. Participants will be enrolled in Cohort 1 initially and then dosing in subsequent cohorts will proceed after safety review team (SRT) review of emerging data.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 4
~4650

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,076 Previous Clinical Trials
837,329 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
340 Previous Clinical Trials
185,566 Total Patients Enrolled

Media Library

B/F/TAF (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT05585307 — Phase 1
HIV Research Study Groups: Substudy-03: GS-6212, Substudy-02: GS-1720, Substudy-01: GS-5894
HIV Clinical Trial 2023: B/F/TAF Highlights & Side Effects. Trial Name: NCT05585307 — Phase 1
B/F/TAF (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585307 — Phase 1
HIV Patient Testimony for trial: Trial Name: NCT05585307 — Phase 1

Frequently Asked Questions

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

Has the FDA granted approval for Substudy-01: GS-5894 yet?

"Since this is a Phase 1 trial, which has limited evidence supporting safety and efficacy, our team at Power gives an assessment of ‘1’ to Substudy-01: GS-5894."

Answered by AI

Who meets the criteria for taking part in this medical experiment?

"This medical study requires 110 individuals aged between 18 and 65 who possess HIV-1. Participants must have a plasma RNA count of 5000 to 400,000 copies/mL at the screening stage, with CD4 cell counts greater than 200 cells/mm^3. They must also be ARV treatment naive or experienced but not exposed to investigational ARVs in this trial within 12 weeks prior to screening, as well as having adequate renal function (eGFR ≥ 70 mL/min/1.73m^2). Additionally, they should present no clinically significant abnormalities on ECG scans at screening and be willing to initiate an SOC ART regimen"

Answered by AI

Is this research study open to elderly individuals aged 75 and up?

"This medical trial is targeting patients aged between 18 and 65; however, younger participants can join one of the eighteen studies meant for them while those above 65 are eligible to take part in 85 other trials."

Answered by AI

Are there vacancies available for participants in this experiment?

"As verified by clinicaltrials.gov, recruitment for this experiment is ongoing; it was initially posted on October 26th 2022 and its details were last modified on November 15th 2022."

Answered by AI

Are there multiple facilities executing this experiment within the state's boundaries?

"Presently, this research project is recruiting at 9 medical sites. These locales include Austin, West Palm Beach and Fort Pierce in addition to other nearby areas. It may be wise to choose the closest trial centre if you decide to take part, thus limiting travel needs."

Answered by AI

What is the total expected enrollment for this research trial?

"Affirmative. The information hosted on clinicaltrials.gov shows that this research trial, which was first made public on October 26th 2022 is actively recruiting patients; with 110 participants to be enrolled at 9 sites in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Nevada
California
What site did they apply to?
Prism Health North Texas
The Crofoot Research Center, Inc.,Substudy-01
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

to get hiv help help others.
PatientReceived 2+ prior treatments
~12 spots leftby May 2024