689 Participants Needed

Bictegravir + Lenacapavir for HIV

(ARTISTRY-1 Trial)

Recruiting at 98 trial locations
GC
Overseen ByGilead Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Gilead Sciences
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two HIV medications, bictegravir and lenacapavir, either separately or combined into one pill. It aims to see if these new treatments work better than current therapies for people living with HIV. These drugs help control HIV by stopping the virus from making more copies of itself. Bictegravir is a newly approved medication combined with other drugs, while lenacapavir is a long-acting medication recently approved in the EU.

Will I have to stop taking my current medications?

The trial involves switching to the study drugs, so you may need to stop your current HIV medications. The protocol does not specify a washout period, but it seems likely that you will transition from your current regimen to the study drugs.

Is Bictegravir (BIC) safe for humans?

Bictegravir (BIC), a component of Biktarvy, is generally well tolerated in humans, with common side effects including diarrhea, nausea, and headache. Real-world studies have shown higher rates of adverse effects and discontinuation compared to clinical trials, but it is still considered safe for treating HIV.12345

What makes the drug Bictegravir + Lenacapavir unique for HIV treatment?

Bictegravir + Lenacapavir is unique because it combines two potent antiretroviral drugs, offering a high barrier to resistance and potentially simplifying treatment with fewer pills, which can improve adherence and outcomes for people living with HIV.678910

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for people with HIV-1 who have been successfully treated but are on complex regimens, including multiple pills or injections plus oral meds. They should have no resistance to bictegravir, stable kidney function (not on dialysis), and undetectable HIV levels for at least 6 months. It's not for those with active tuberculosis, prior lenacapavir use, or chronic hepatitis B.

Inclusion Criteria

At least one documented plasma HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening must be < 50 copies/mL
My kidneys work well enough, and I don't need dialysis.
Plasma HIV-1 RNA measurements in the 6 months prior to screening must be < 50 copies/mL
See 4 more

Exclusion Criteria

I have chronic hepatitis B.
I do not have an active tuberculosis infection.
I have previously used or been exposed to lenacapavir.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 2

Participants switch from their stable baseline regimen to a regimen of BIC 75 mg + LEN 25 mg or BIC 75 mg + LEN 50 mg, with a 2-day loading dose regimen of LEN 600 mg, treated for at least 24 weeks

24 weeks

Treatment Phase 3

Participants switch to BIC/LEN 75 mg/50 mg fixed-dose combination, treated for at least 48 weeks

48 weeks

Extension Period

Participants have the option to continue receiving BIC/LEN 75 mg/50 mg FDC

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bictegravir
  • Lenacapavir
Trial Overview The study compares the effects of switching to a new regimen of bictegravir plus lenacapavir versus continuing current therapy in Phase 2. In Phase 3, it looks at a fixed-dose combination of these drugs against current treatments in people living with HIV.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)Experimental Treatment1 Intervention
Group II: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mgExperimental Treatment2 Interventions
Group III: Phase 2: BIC 75 mg + LEN 50 mgExperimental Treatment2 Interventions
Group IV: Phase 2: Stable Baseline Regimen (SBR)Active Control1 Intervention
Group V: Phase 3: Stable Baseline RegimenActive Control1 Intervention

Bictegravir is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Bictegravir for:
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Approved in United States as Bictegravir for:
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Approved in Canada as Bictegravir for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Bictegravir (BIC) is a highly effective second-generation HIV treatment that shows strong antiviral activity against both wild-type and resistant strains, with virologic suppression rates comparable to first-line therapies in clinical trials.
BIC has a high genetic barrier to resistance, can be taken once daily due to its long half-life of 18 hours, and is generally well tolerated, with only mild side effects like diarrhea, nausea, and headache.
Bictegravir, a novel integrase inhibitor for the treatment of HIV infection.Zeuli, J., Rizza, S., Bhatia, R., et al.[2021]
Biktarvy has shown efficacy in real-world clinical practice that is comparable to results from phase III trials, indicating it is effective for treating HIV-1 infection.
However, real-world studies reported higher rates of adverse effects and discontinuation compared to clinical trials, highlighting the need for further research on diverse populations, including women and ethnic minorities.
Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review.Peters, E., Iwuji, AC.[2023]
Bictegravir (BIC) is a highly effective integrase strand-transfer inhibitor for treating HIV-1, showing rapid absorption and high cumulative dose recovery in both humans (95.3%) and nonclinical species (>80%).
BIC has a favorable pharmacokinetic and metabolic profile, with minimal clinically relevant drug-drug interactions, making it a promising option compared to other integrase inhibitors.
Human and nonclinical disposition of [14C]bictegravir, a potent integrase strand-transfer inhibitor for the treatment of HIV-1 infection.Subramanian, R., Ling, J., Wang, J., et al.[2023]

Citations

Bictegravir, a novel integrase inhibitor for the treatment of HIV infection. [2021]
Efficacy, safety and tolerability of Biktarvy in HIV-1 infection: A scoping review. [2023]
Human and nonclinical disposition of [14C]bictegravir, a potent integrase strand-transfer inhibitor for the treatment of HIV-1 infection. [2023]
Biktarvy for the treatment of HIV infection: Progress and prospects. [2023]
Human pharmacokinetics prediction with an in&#160;vitro-in&#160;vivo correction factor approach and in&#160;vitro drug-drug interaction profile of bictegravir, a potent integrase-strand transfer inhibitor component in approved biktarvy&#174; for the treatment of HIV-1 infection. [2023]
The potential role of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) single-tablet regimen in the expanding spectrum of fixed-dose combination therapy for HIV. [2021]
A phase II trial of tegafur-uracil plus leucovorin (LV) in the treatment of advanced biliary tract carcinomas. [2019]
NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). [2022]
Phase II activity of belinostat (PXD-101), carboplatin, and paclitaxel in women with previously treated ovarian cancer. [2018]
10.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) as first-line treatment for advanced biliary tract adenocarcinoma: a phase 2 clinical trial. [2023]
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