7 completed. 7 Phase 2, 5 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 7 |
| Phase 3 | 5 | Completed 5 |
| Phase 1 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 (4) · Acquired Immunodeficiency Syndrome (1) · Cytomegalovirus Infections (1) · Meningitis (1) · Pneumonia (1) · Tuberculosis (1)
dolutegravir (2) · Adenosine Monophosphate (1) · Antitubercular Agents (1) · CDP-Diacylglycerol-Inositol 3-Phosphatidyltransferase (1) · Clinical Protocols (1) · Emtricitabine (1) · Indinavir (1) · Meropenem (1) · Nelfinavir (1) · Nevirapine (1) · Racivir (1) · Ritonavir (1) · Saquinavir (1) · Standard of Care (1) · Stavudine (1)
United Kingdom (5) · Uganda (4) · Spain (3) · Thailand (3) · Zimbabwe (3) · France (2) · Germany (2) · Netherlands (2) · Portugal (2) · South Africa (2) · Argentina (1) · Côte d’Ivoire (1) · Ireland (1) · Italy (1) · Malawi (1)
Ann J. Melvin, MD (1) · Cinta Moraleda, MD, PhD (1) · Diana Gibb (1) · Ross E. McKinney, Jr., MD (1)
PMID 21288774, PMID 32763217, PMID 33446115, PMID 34817414, PMID 34965338, PMID 35761406, PMID 35868341, PMID 36055295, PMID 36724434, PMID 37304494, PMID 37766505, PMID 39978387, PMID 40307889, PMID 41579881, PMID 42016921, PMID 42468541, PMID 42705257
2009 (1), 2014 (1), 2019 (1)