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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
Be older than 18 years old
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
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
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 moreTrial 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: BavtavirineExperimental Treatment3 Interventions
Participants will receive bavtavirine. 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
~4900
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,369 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,583 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any medications that the study does not allow.I am willing to start a specific HIV treatment on Day 11.I have had an AIDS-defining condition.I have an active hepatitis C infection.I have not had a serious infection or tuberculosis in the last 30 days.I have not taken any prohibited medications recently.My HIV has shown resistance to the main 4 types of HIV medications.I have or had HIV treatment or prevention with long-acting injections.I am willing to start standard HIV treatment on Day 11 if in substudy-02 or -03.I have or had severe liver problems, like fluid in the abdomen, confusion, or bleeding veins in my esophagus.I have chronic hepatitis B as confirmed by specific blood tests.My kidney function is good, with an eGFR of 70 or higher.I haven't taken HIV drugs recently or those specific to the study.You have a CD4 cell count of at least 200 cells/mm^3 at screening.My kidney function is good, with an eGFR of 70 or higher.I am willing to start the recommended HIV treatment on Day 11 or if needed sooner.I have not taken any HIV drugs or only those not being tested in this study, and none in the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy-03: GS-6212
- Group 2: Substudy-02: GS-1720
- Group 3: Substudy-01: Bavtavirine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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