7 completed, 3 active not recruiting, 2 not yet recruiting, 2 unknown. 14 Phase 3, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 7, Active not recruiting 3, Not yet recruiting 2, Unknown 2 |
| Phase 2 | 7 | Completed 5, Active not recruiting 1, Unknown 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 |
|---|---|---|---|---|---|---|
| An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa Dolutegravir (DTG), Abacavir (ABC), Lamivudine (3TC) - HIV Infection | Phase 3 | Not yet recruiting | University College, London | 800 | 2026-11-01 | 2026-08-28 |
| Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination. Abrysvo, Nirsevimab - RSV Immunization | Phase 3 | Not yet recruiting | PENTA Foundation | 1500 | 2025-09-01 | 2025-06-27 |
| Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP) - Neonate, Maternal Transmission | Phase 3 | Active not recruiting | Jean-Pierre Van geertruyden | 359 | 2025-06-23 | 2026-01-30 |
| Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC MVA-BN standard regimen, MVA-BN half-dose regimen - Mpox (Monkeypox), Vaccination | Phase 3 | Active not recruiting | Jean-Pierre Van geertruyden | 344 | 2025-05-29 | 2026-04-29 |
| Long-Acting Treatment in Adolescents (LATA) Cabotegravir, Rilpivirine Drug Combination, TLD - Hiv, HIV Infections | Phase 3 | Unknown | University College, London | 476 | 2023-06-22 | 2024-04-29 |
| 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 |
| 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 |
| Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy Raltegravir, Fluconazole, Azithromycin - Human Immunodeficiency Virus | Phase 3 | Completed | Anna Griffiths, MRC | 1805 | 2013-06-01 | 2016-04-20 |
| Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis Meropenem, Ampicillin + gentamicin or cefotaxime + gentamicin - Sepsis | Phase 3 | Completed | PENTA Foundation | 272 | 2012-09-01 | 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) · Acquired Immunodeficiency Syndrome (3) · Mpox, Monkeypox (2) · Smallpox (2) · Cytomegalovirus Infections (1) · Pneumonia (1) · Sepsis (1) · Tuberculosis (1)
dolutegravir (3) · Lamivudine (2) · Racivir (2) · Ritonavir (2) · abacavir (2) · efavirenz (2) · Adenosine Monophosphate (1) · Albendazole (1) · Ampicillin (1) · Antitubercular Agents (1) · Azithromycin (1) · CDP-Diacylglycerol-Inositol 3-Phosphatidyltransferase (1) · Cefotaxime (1) · Darunavir (1) · Emtricitabine (1)
Uganda (7) · United Kingdom (6) · Thailand (5) · South Africa (4) · Spain (4) · Zimbabwe (4) · France (3) · Germany (3) · Democratic Republic of the Congo (2) · Ireland (2) · Italy (2) · Kenya (2) · Malawi (2) · Netherlands (2) · Portugal (2)
Ann J. Melvin, MD (1) · Cinta Moraleda, MD, PhD (1) · Diana Gibb (1) · Diana M Gibb (1) · Irja Lutsar (1) · Jean-Pierre Aboulker (1) · Karina M Butler, MRCPI (1) · Ross E. McKinney, Jr., MD (1) · Sarah L Pett (1) · Ursula Trafojer (1)
PMID 21288774, PMID 28213595, PMID 29653915, PMID 29684092, PMID 30513108, PMID 32103268, PMID 32763217, PMID 33446115, PMID 34432828, PMID 34817414, PMID 34965338, PMID 35761406, PMID 35868341, PMID 36055295, PMID 36724434, PMID 37304494, PMID 37766218, PMID 37766505, PMID 38636725, PMID 39978387, PMID 40307889, PMID 41512916, PMID 41579881, PMID 42016921, PMID 42372625, PMID 42468541, PMID 42521300, PMID 42753775
2009 (2), 2014 (1), 2019 (1), 2025 (1)