What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), often include drugs like dolutegravir, lamivudine, and raltegravir. Known side effects of these treatments can include nausea, diarrhea, headache, and fatigue. Some patients may experience more severe side effects such as liver toxicity, hypersensitivity reactions, or metabolic complications. Novel antiretrovirals being studied, such as bavtavirine and GS-1720, aim to inhibit HIV-1 replication and may have similar side effects, though specific data on these newer drugs are still being evaluated.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV-1, focusing on inhibiting the virus's replication. Notable drugs include Tenofovir alafenamide and Tenofovir disoproxil fumarate, often coformulated with other agents like elvitegravir, cobicistat, and emtricitabine. These drugs work by targeting the reverse transcriptase enzyme, crucial for viral replication. Other approved treatments include protease inhibitors, integrase strand transfer inhibitors, and non-nucleoside reverse transcriptase inhibitors, all aimed at reducing viral load and improving patient outcomes.

What other types of research exist?

Promising novel alternatives to current antiretrovirals for HIV patients include bavtavirine, GS-1720, and GS-6212. These drugs are being evaluated in clinical trials and may offer new options for inhibiting HIV-1 replication.

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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: day 1 predose up to day 39; substudy-02: day 1 predose up to day 60

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new medicines to stop HIV from multiplying in people living with HIV. The goal is to find effective treatments to manage their infection and improve their health.

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.

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.

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: day 1 predose up to day 39; substudy-02: day 1 predose up to day 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~substudy-01: day 1 predose up to day 39; substudy-02: day 1 predose up to day 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and substudy-01: day 1 predose up to day 39; substudy-02: day 1 predose up to day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percentage of Participants with Emergence of Viral Resistance to the ARV Class of the Given Drug

Substudy-01, Substudy-02, and Substudy-03: PK Parameter of: AUC of bavtavirine, GS-1720, and GS-6212

Substudy-01, Substudy-02, and Substudy-03: PK Parameter: Ct of bavtavirine, GS-1720, and GS-6212

+1 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: 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

Standard of Care (Substudy 01)

2022

Completed Phase 1

~50

Standard of Care (Substudy 02)

2022

Completed Phase 1

~50

Standard of Care (Substudy 03)

2022

Completed Phase 1

~50

GS-6212

2022

Completed Phase 1

~50

bavtavirine

2022

Completed Phase 1

~50

B/F/TAF

2016

Completed Phase 4

~5170

GS-1720

2022

Completed Phase 1

~50

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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].