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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:

Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com


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Be Part of Research - Trial Details - Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
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Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

Recruiting

Open to: ALL

Age: 18.0 - N/A

London London Birmingham Brighton Liverpool London London Manchester

Medical Conditions

HIV Infections

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 goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP).

The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP.

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:

Oct 2024 Jan 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administered subcutaneously

Intervention Arm Group : LEN Open Label Extension (OLE) Phase;Randomized Phase: Lenacapavir (LEN) Group;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : LEN Open Label Extension (OLE) Phase;Randomized Phase: Lenacapavir (LEN) Group;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Pharmacokinetic (PK) Tail Phase: F/TDF;Randomized Phase: F/TDF;



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.

  • Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster Hospital
    London
    SW10 9NH
  • Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation Trust
    London
    SE5 9RS
  • University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands Hospital
    Birmingham
    B9 5SS
  • Clinical Research Facility, University Hospitals Sussex NHS Foundation Trust
    Brighton
    BN2 3EW
  • Axess Sexual Health, Liverpool University Hospitals NHS Trust
    Liverpool
    L7 8YE
  • Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS Trust
    London
    E11BB
  • Homerton Healthcare NHS Foundation Trust, Homerton University Hospital
    London
    E9 6SR
  • Manchester University NS Foundation Trust
    Manchester
    M13 0FH

Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com



The study is sponsored by Gilead Sciences



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Read full details for Trial ID: NCT06513312
Last updated 11 February 2025

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