Table 3.
A summary of the Gilead-sponsored interventional clinical studies on LEN for the treatment of HIV infection.
| NCT Number (Other IDs; Start Date; Completion Date; Last Update) |
Objective/Interventions (Number Enrolled; Allocation; Primary Purpose) |
Phase (Status; Location; Results) |
|---|---|---|
|
NCT05502341 (GS-US-621-6289 and 2022-500929-33-00; 16 August 2022; January 2026; 18 January 2023) |
Safety and efficacy of Bictegravir/LEN versus ART (671; Randomized; Treatment) |
2/3 (Recruiting; United States; Not available) |
|
NCT05052996 (GS-US-563-6041; 5 October 2021; August 2023; 21 December 2022) |
Safety and efficacy of the combination of LEN and islatravir (136; Randomized; Treatment) |
2 (Active; United States; Not available) |
|
NCT04994509 (GS-US-412-5624 and DOH-27-072021-6125; 30 August 2021; March 2024; 18 January 2023) |
Safety and efficacy of LEN and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP—PURPOSE 1 (5010; Randomized; Prevention) |
3 (Recruiting; South Africa; Not available) |
|
NCT04925752 (GS-US-528-9023 and DOH-27-102021-6681; 28 June 2021; January 2024; 31 January 2023) |
Safety and efficacy of LEN in preventing HIV-1 infection—PURPOSE 2 (3000; Randomized; Treatment) |
3 (Recruiting; United States; Not available) |
|
NCT04811040 (GS-US-536-5816; 8 April 2021; 9 June 2022; 8 November 2022) |
Safety and tolerability of the combination of LEN with teropavimab and zinlirvimab (32; Randomized; Treatment) |
1 (Active; United States; Not available) |
|
NCT04150068 (GS-US-200-4625 and 2019-003814-16; 21 November 2019; 5 October 2020; 19 October 2022) |
Safety and efficacy of LEN as an add-on to a failing HIV-1 therapy due to drug resistance—CAPELLA (72; Randomized; Treatment) |
2/3 (Active; United States; Results posted on 20 October 2021) |
|
NCT04143594 (GS-US-200-4334; 22 November 2019; 30 September 2021; 19 December 2022) |
Safety and efficacy of regimens (LEN + ARTs) against HIV-1—CALIBRATE (183; Randomized; Treatment) |
2 (Active; United States; Results posted on 19 December 2022) |
|
NCT03739866 (GS-US-200-4072; 26 November 2018; 15 June 2020; 9 April 2021) |
Safety, antiviral activity and pharmacokinetic study of LEN in HIV-1 infected patients (53; Randomized; Treatment) |
1 (Completed; United States; Results posted on 9 December 2020) |