Calendario›INCY›Dexelvucitabine · DECLARE
Dexelvucitabine · DECLARE
Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs
Ensayo de INCYTE CORP en HIV Infections · Human Immunodeficiency Virus (del registro, en inglés).
Más ensayos de: Infección por VIH.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 250
- Centros
- 11
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2006.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Development program ended due to inability to pair with other cytidine analogs and higher risk of hyperlipasemia when not used with 3TC/FTC.».
Qué mide
Percent of subjects with >= 1.0 log10 decrease in viral load from Baseline to Week 24 based on non-completer equals failure (NC=F) (Week 48 compared to baseline) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).
Más ensayos de INCY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| tafasitamab · InMIND | Fase 3 | En marcha, sin reclutar | feb 2024 (real) |
| Tafasitamab · MINDway | Fase 1/2 | En marcha, sin reclutar | jul 2024 (real) |
| Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) | no aplica | Reclutando pacientes | jun 2025 (prevista, ya pasada: sin actualizar en el registro) |
| tafasitamab · J-MIND | Fase 1/2 | En marcha, sin reclutar | jul 2025 (real) |
| INCA034176 | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Povorcitinib | Fase 3 | En marcha, sin reclutar | feb 2026 (real) |
Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00300573), actualizada en ago 2018.