Clinical trials: sponsored by Gilead Sciences
- Lead sponsor (exact) Gilead Sciences
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
- 17 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
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
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
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
HIV Pre-exposure Prophylaxis
Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of…
- Trial name
- PURPOSE 365 (NCT07047716)
- Testing
- Lenacapavir Injection, Lenacapavir Tablet
- Where
- 31 sites in United States
- Volunteers
- 339 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV-1-infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and…
- Trial name
- NCT07055451
- Testing
- B/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in…
- Trial name
- NCT02932150
- Testing
- TAF
- Where
- 39 sites in United States, Belgium and 6 more
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
RSV Infection
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection.
- Trial name
- NCT06784973
- Testing
- Obeldesivir
- Where
- 56 sites in United States, Japan
- Volunteers
- 4 people
- Sponsor
- Gilead Sciences
HIV-1-infection
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and…
- Trial name
- NCT06749054
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)
- Where
- 9 sites in United States, South Africa
- Volunteers
- 12 people
- Sponsor
- Gilead Sciences
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in…
- Trial name
- NCT02016924
- Testing
- ATV, DRV, Cobicistat
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 133 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir…
- Trial name
- NCT01854775
- Testing
- E/C/F/TAF, E/C/F/TAF (Low Dose)
- Where
- 16 sites in United States, South Africa and 3 more
- Volunteers
- 129 people
- Sponsor
- Gilead Sciences
HIV-1
Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen
The primary objective of this study is to confirm the TAF dose and to evaluate the pharmacokinetics (PK) of TAF, safety, and tolerability of F/TAF in children and adolescents with HIV-1 who are virologically suppressed (defined…
- Trial name
- NCT02285114
- Testing
- F/TAF, 3rd ARV agent, Boosted PIs
- Where
- 8 sites in United States, Panama and 1 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
COVID-19
Study of Obeldesivir in Children and Adolescents With COVID-19
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).
- Trial name
- NCT05996744
- Testing
- Obeldesivir
- Where
- 18 sites in United States
- Volunteers
- 3 people
- Sponsor
- Gilead Sciences
COVID-19
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness.
- Trial name
- OAKTREE (NCT05715528)
- Testing
- Obeldesivir
- Where
- 113 sites in United States, Japan
- Volunteers
- 2,011 people
- Sponsor
- Gilead Sciences
COVID-19
Study of Remdesivir in Participants Below 18 Years Old With COVID-19
The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).
- Trial name
- CARAVAN (NCT04431453)
- Testing
- Remdesivir
- Where
- 32 sites in United States, Italy and 2 more
- Volunteers
- 59 people
- Sponsor
- Gilead Sciences
COVID-19
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney…
- Trial name
- REDPINE (NCT04745351)
- Testing
- Remdesivir, Standard of Care
- Where
- 63 sites in United States, Brazil and 4 more
- Volunteers
- 249 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial.
- Trial name
- NCT02510300
- Testing
- Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF), Sofosbuvir/Velpatasvir (SOF/VEL)
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 461 people
- Sponsor
- Gilead Sciences