Sunlenca (lenacapavir) / Gilead 
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16 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Sunlenca (lenacapavir) / Gilead
ARTISTRY-2, NCT06333808: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Recruiting
3
546
Canada, Japan, US, RoW
Bictegravir, GS-9883, Lenacapavir, GS-6207, B/F/TAF, Biktarvy ®, Placebo to match B/F/TAF, Placebo to match BIC/LEN
Gilead Sciences
HIV-1-infection
12/25
12/29
PURPOSE 1, NCT04994509: Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection

Active, not recruiting
3
5368
RoW
Oral Lenacapavir (LEN), GS-6207, Subcutaneous (SC) Lenacapavir (LEN), F/TAF, Descovy®, F/TDF, Truvada®, Placebo SC LEN, PTM Oral LEN, PTM F/TAF, PTM F/TDF
Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
09/24
07/27
PURPOSE 2, NCT04925752: Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

Active, not recruiting
3
3295
US, RoW
Oral Lenacapavir (LEN), GS-6207, F/TDF, Truvada®, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)
Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
01/25
04/27
2019-003814-16: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living with HIV-1 Infection with Multidrug Resistance Estudio de fase 2/3 para evaluar la seguridad y eficacia del inhibidor de la cápside de acción prolongada GS-6207 en combinación con un tratamiento de base optimizado en pacientes con infección por VIH-1 altamente tratados y con multirresistencia a fármacos

Not yet recruiting
2/3
100
Europe
GS-6207, GS-6207, Tablet, Solution for injection
Gilead Sciences, Inc., GILEAD SCIENCES INCORPORATED, Gilead Sciences, Inc.
Human Immunodeficiency Virus (HIV-1) Infection Infección por el virus de la inmunodeficiencia humana (HIV-1), Human Immunodeficiency Virus (HIV-1) Infection Infección por el virus de la inmunodeficiencia humana (HIV-1), Diseases [C] - Virus Diseases [C02]
 
 
CAPELLA, NCT04150068: Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

Active, not recruiting
2/3
72
Europe, Canada, Japan, US, RoW
Oral Lenacapavir, Sunlenca®, GS-6207, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir, Failing ARV Regimen, Optimized Background Regimen (OBR)
Gilead Sciences
HIV-1-infection
10/20
12/25
ARTISTRY-1, NCT05502341: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Recruiting
2/3
671
Europe, Canada, Japan, US, RoW
Bictegravir, GS-9883, Lenacapavir, GS-6207, BIC/LEN FDC, Stable Baseline Regimen
Gilead Sciences
HIV-1-infection
01/26
11/28
CALIBRATE, NCT04143594: Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV

Completed
2
183
US, RoW
Oral Lenacapavir, GS-6207, F/TAF, Descovy®, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF, Biktarvy®
Gilead Sciences
HIV-1-infection
09/21
09/23
NCT05052996: Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Active, not recruiting
2
142
US
ISL, LEN, GS-6207, B/F/TAF, Biktarvy®
Gilead Sciences, Merck Sharp & Dohme LLC
HIV-1 Infection
12/23
11/27
NCT05729568: A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Active, not recruiting
2
83
Canada, US, RoW
Teropavimab, GS-5423, Zinlirvimab, GS-2872, Lenacapavir Tablet, GS-6207, Lenacapavir Injection, Antiretroviral Therapy
Gilead Sciences
HIV Infections
07/24
12/29
PURPOSE 3, NCT06101329: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

Recruiting
2
250
US
Lenacapavir Tablet, GS-6207, Lenacapavir Injection, Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF), Truvada®
Gilead Sciences, HIV Prevention Trials Network
Pre-Exposure Prophylaxis of HIV Infection
01/28
01/28
PURPOSE-4, NCT06101342: Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)

Recruiting
2
250
US
Lenacapavir Injection, GS-6207, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Truvada®
Gilead Sciences, HIV Prevention Trials Network, National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID)
Pre-Exposure Prophylaxis of HIV Infection
07/27
07/27
NCT04811040: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection

Completed
1b
32
US
Oral Lenacapavir, GS-6207, Subcutaneous Lenacapavir, Teropavimab, 3BNC117-LS, GS-5423, Zinlirvimab, 10-1074-LS, GS-2872
Gilead Sciences
HIV-1 Infection
04/23
10/23
ACTRN12620000272998p: A study comparing how fast the trial drug GS-6207 is processed and cleared from the body, in healthy adults and in adults with severely reduced kidney function.

Not yet recruiting
1
20
 
Gilead Sciences, Gilead Sciences
HIV
 
 
ACTRN12623000535673: GS-US-200-5717: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir

Not yet recruiting
1
50
 
Gilead Sciences, Gilead Sciences
HIV
 
 
ACTRN12623000536662: GS-US-200-5710: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir

Not yet recruiting
1
50
 
Gilead Sciences, Gilead Sciences
HIV
 
 
NCT06289361: Cohort IMEA 070 -Lenacapavir Compassional

Not yet recruiting
N/A
58
Europe
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, Saint-Louis Hospital, Paris, France, Bichat Hospital, Saint Antoine University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
HIV Infections
04/24
07/24

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