Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Back

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Brighton Birmingham London London London

Medical Conditions

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2022 Sep 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Tablets administered orally without regard to food

Intervention Arm Group : Phase 2: BIC 75 mg + LEN 50 mg;Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg;

Intervention Type : DRUG
Intervention Description : Tablets administered orally without regard to food

Intervention Arm Group : Phase 2: BIC 75 mg + LEN 50 mg;Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg;

Intervention Type : DRUG
Intervention Description : Tablets administered orally without regard to food

Intervention Arm Group : Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC);

Intervention Type : DRUG
Intervention Description : SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva).

* Nucleos(t)ide Reverse Transcriptase Inhibitors:

* Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine* Non-Nucleosite Reverse Transcriptase Inhibitors:

* Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine* Integrase Inhibitors:

* Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir* Protease Inhibitors:

* Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir* Chemokine Co-receptor 5 (CCR5) Antagonist:

* Maraviroc* Fusion Inhibitors:

* Enfuvirtide* gp120 Attachment Inhibitor:

* Fostemsavir* Anti-CD4 Monoclonal Antibodies:

* Ibalizumab-uiyk

Intervention Arm Group : Phase 2: Stable Baseline Regimen (SBR);Phase 3: Stable Baseline Regimen;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Brighton and Sussex University Hospitals NHS Trust
    Brighton
    BN2 3EW
  • Department of HIV & Sexual Medicine
    Birmingham
    B9 5SS
  • Barts Health NHS Trust
    London
    E1 1BB.
  • HIV medicine and infectious diseases
    London
    SE5 9RS
  • St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
    London
    SW109NH


The study is sponsored by Gilead Sciences



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: NCT05502341
Last updated 25 November 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top