7 completed, 2 active not recruiting, 2 not yet recruiting, 2 recruiting. 16 Phase 2, 7 Phase 3, 5 Phase 1.
Follow PENTA Foundation: new trials by email
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl) - HIV -1 Infection | Phase 1 / Phase 2 | Not yet recruiting | Hospital Universitario 12 de Octubre | 87 | 2027-01-01 | 2026-08-20 |
| Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2) Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl), Broadly neutralizing antibody (bNAb) VRC07-523-LS - HIV -1 Infection | Phase 1 / Phase 2 | Not yet recruiting | Hospital Universitario 12 de Octubre | 73 | 2027-01-01 | 2026-08-20 |
| A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus zelicapavir, Placebo - RSV Infection, RSV | Phase 2 | Recruiting | Enanta Pharmaceuticals, Inc | 150 | 2026-07-09 | 2026-07-20 |
| Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV Remdesivir - Respiratory Syncytial Virus (RSV) | Phase 2 | Recruiting | PENTA Foundation | 120 | 2025-07-16 | 2025-07-23 |
| Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV DRV/r FDC (120/20mg) - HIV Infections | Phase 1 / Phase 2 | Withdrawn | PENTA Foundation | 2025-02-01 | 2026-03-05 | |
| UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen, Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF) - HIV Infection | Phase 2 | Completed | PENTA Foundation | 53 | 2024-12-11 | 2026-03-04 |
| Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance Fostemsavir - HIV Infections With Multi Drug Resistant Virus | Phase 1 / Phase 2 | Active not recruiting | PENTA Foundation | 60 | 2022-06-30 | 2026-03-05 |
| DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old Dolutegravir (DTG) and lamivudine (3TC), SOC - HIV Infections | Phase 2 / Phase 3 | Active not recruiting | PENTA Foundation | 386 | 2022-04-22 | 2026-03-04 |
| Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia Valganciclovir Oral Solution [Valcyte], Tuberculostatic Agents - Pneumonia, HIV/AIDS | Phase 2 / Phase 3 | Completed | Hospital Universitario 12 de Octubre | 563 | 2020-03-01 | 2025-09-19 |
| Neonatal Vancomycin Trial Vancomycin - Late Onset Neonatal Sepsis | Phase 2 | Terminated | PENTA Foundation | 242 | 2017-02-27 | 2020-09-09 |
| ODYSSEY (PENTA 20) Dolutegravir, Standard of Care - HIV Infection | Phase 2 / Phase 3 | Completed | PENTA Foundation | 792 | 2016-09-20 | 2025-07-29 |
| Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children DTG +DRV/r, SOC - HIV Infection | Phase 2 / Phase 3 | Completed | PENTA Foundation | 318 | 2016-06-01 | 2021-03-30 |
| Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis Meropenem - Meningitis | Phase 1 / Phase 2 | Completed | PENTA Foundation | 51 | 2013-02-01 | 2015-02-16 |
| BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection efavirenz - HIV | Phase 2 / Phase 3 | Unknown | PENTA Foundation | 160 | 2011-04-01 | 2015-03-02 |
| KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18) Kaletra dosed once daily, kaletra dosed twice daily - Antiretroviral Therapy in HIV-1 Infected Children | Phase 2 / Phase 3 | Completed | PENTA Foundation | 173 | 2010-08-01 | 2013-10-28 |
| Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT), NNRTIs (EFV, NVP), PIs (AMP, IDV, LPV/r, NFV, SQV, RTV) - HIV Infections | Phase 2 / Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 266 | 2002-08-01 | 2021-11-05 |
HIV Infections (6) · Respiratory Syncytial Virus Infections (2) · Acquired Immunodeficiency Syndrome (1) · Cytomegalovirus Infections (1) · Meningitis (1) · Neonatal Sepsis (1) · Pneumonia (1) · Respiration Disorders (1) · Sepsis (1) · Tuberculosis (1)
dolutegravir (3) · Broadly Neutralizing Antibodies (2) · Sodium Chloride (2) · efavirenz (2) · Adenosine Monophosphate (1) · Antitubercular Agents (1) · CDP-Diacylglycerol-Inositol 3-Phosphatidyltransferase (1) · Clinical Protocols (1) · Emtricitabine (1) · Indinavir (1) · Lamivudine (1) · Meropenem (1) · Nelfinavir (1) · Nevirapine (1) · Racivir (1)
United Kingdom (8) · Thailand (7) · Uganda (7) · Spain (5) · South Africa (4) · Zimbabwe (4) · France (3) · Germany (3) · United States (3) · Ireland (2) · Italy (2) · Netherlands (2) · Portugal (2) · Ukraine (2) · Argentina (1)
Albert Faye (1) · Ann J. Melvin, MD (1) · Cinta Moraleda, MD, PhD (1) · Diana Gibb (1) · Karina M Butler, MRCPI (1) · Mike Sharland, MD, FRCPCH (1) · Pablo Rojo (1) · Ross E. McKinney, Jr., MD (1) · Tavitiya Sudjaritruk (1) · Tim R Cressey (1)
PMID 21288774, PMID 28213595, PMID 29684092, PMID 32763217, PMID 33446115, PMID 34817414, PMID 34843669, PMID 34965338, PMID 35761406, PMID 35868341, PMID 36055295, PMID 36724434, PMID 37304494, PMID 37766218, PMID 37766505, PMID 38636725, PMID 39978387, PMID 40307889, PMID 41579881, PMID 41735855, PMID 42016921, PMID 42468541, PMID 42705257
2009 (2), 2014 (1), 2019 (1)