Clinical trials: active, sponsored by Gilead Sciences
Advanced Solid Tumor
Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors
The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability when given as a single medication and as a combined medication in adults with solid tumors, where the…
- Trial name
- NCT07128303
- Testing
- GS-5319, Carboplatin, Pemetrexed
- Where
- 12 sites in United States, South Korea and 1 more
- Volunteers
- 476 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).
- Trial name
- NCT07841990
- Testing
- B/F/TAF, GS-3242, Lenacapavir
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Gilead Sciences
Endometrial Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
The goal of this clinical study is to find out how the study drug, sacituzumab govitecan (SG) works in participants with endometrial cancer who have received prior treatment with platinum-based chemotherapy and immunotherapy…
- Trial name
- ASCENT-GYN-01 (NCT06486441)
- Testing
- Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel
- Where
- 189 sites in United States, Australia and 17 more
- Volunteers
- 640 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
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…
- Trial name
- ARTISTRY-1 (NCT05502341)
- Testing
- Bictegravir, Lenacapavir, BIC/LEN FDC
- Where
- 94 sites in United States, Argentina and 13 more
- Volunteers
- 689 people
- Sponsor
- Gilead Sciences
HIV Infections
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States.
- Trial name
- PROPEL (NCT07473778)
- Testing
- Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF)
- Where
- 44 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Gilead Sciences
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung…
- Trial name
- EVOKE-SCLC-04 (NCT06801834)
- Testing
- Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only)
- Where
- 219 sites in United States, Argentina and 21 more
- Volunteers
- 695 people
- Sponsor
- Gilead Sciences
Advanced Microsatellite Stable Colorectal Cancer
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced…
- Trial name
- NCT07527858
- Testing
- Denikitug, Nivolumab, Bevacizumab
- Where
- 15 sites in United States, Australia and 2 more
- Volunteers
- 170 people
- Sponsor
- Gilead Sciences
HIV-1-infection
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and…
- Trial name
- NCT06337032
- Testing
- F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet)
- Where
- 15 sites in Argentina, Panama and 4 more
- Volunteers
- 350 people
- Sponsor
- Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV-1-infection
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy…
- Trial name
- NCT07645287
- Testing
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet
- Where
- 57 sites in United States, Australia and 2 more
- Volunteers
- 175 people
- Sponsor
- Gilead Sciences
Advanced Solid Tumors
Study of GS-2426 in Participants With Advanced Solid Tumors
The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.
- Trial name
- NCT07601243
- Testing
- GS-2426
- Where
- 6 sites in United States, Spain
- Volunteers
- 174 people
- Sponsor
- Gilead Sciences
Triple Negative Breast Cancer
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC)…
- Trial name
- NCT05633654
- Testing
- Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine
- Where
- 376 sites in United States, Australia and 10 more
- Volunteers
- 1,514 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy…
- Trial name
- NCT07708727
- Testing
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 700 people
- Sponsor
- Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis.
- Trial name
- AFFIRM (NCT06051617)
- Testing
- Seladelpar
- Where
- 217 sites in United States, Argentina and 27 more
- Volunteers
- 402 people
- Sponsor
- Gilead Sciences
Weight Management
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2…
- Trial name
- NCT06562907
- Testing
- GS-4571, Omeprazole
- Where
- 3 sites in United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV-1-infection
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
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency…
- Trial name
- CAPELLA (NCT04150068)
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Failing ARV Regimen
- Where
- 75 sites in United States, Canada and 9 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
The goal of this clinical study is to learn about the safety and tolerability of bictegravir (BIC)/lenacapavir (LEN) and to learn how the study drug interacts with the body in virologically suppressed (VS) children and…
- Trial name
- NCT06532656
- Testing
- Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC, Bictegravir/Lenacapavir
- Where
- 21 sites in United States, Argentina and 3 more
- Volunteers
- 75 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
HIV-1 Infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
The goals of this clinical study are to learn how Bictegravir/Emtricitabine/Tenofovir Alafenamide fixed dose combination (FDC) interacts with the body, confirm the dose, and also to learn more about the safety and tolerability of…
- Trial name
- NCT02881320
- Testing
- B/F/TAF (Adult Strength), B/F/TAF (Low Dose), B/F/TAF (TOS)
- Where
- 25 sites in United States, South Africa and 2 more
- Volunteers
- 177 people
- Sponsor
- Gilead Sciences