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Antiretroviral
Novel Antiretroviral Therapy for HIV
Phase 1
Waitlist Available
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
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
~5130
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV, such as integrase strand transfer inhibitors (InSTIs), work by blocking the HIV integrase enzyme, which is essential for the viral DNA to integrate into the host cell's genome. This prevents the virus from replicating within the host cells.
Other investigational drugs, like those being studied in the trial of novel antiretrovirals, also aim to inhibit various stages of the HIV life cycle, thereby reducing viral load and improving immune function. These treatments are crucial for HIV patients as they help manage the infection, reduce the risk of transmission, and improve overall quality of life.
Advances in antiretroviral therapy.Unwelcome guests with master keys: how HIV enters cells and how it can be stopped.[Resistance to antiretroviral therapy].
Advances in antiretroviral therapy.Unwelcome guests with master keys: how HIV enters cells and how it can be stopped.[Resistance to antiretroviral therapy].
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Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,086 Previous Clinical Trials
848,381 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,531 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-01: Bavtavirine
- Group 2: Substudy-02: GS-1720
- Group 3: Substudy-03: GS-6212
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
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