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EVG

Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

Ensayo de GILEAD SCIENCES, INC. en Acquired Immune Deficiency Syndrome (AIDS) · HIV Infections (del registro, en inglés).

Más ensayos de: Infección por VIH.

Fase

Fase 2/3

Estado

Interrumpido

Participantes

31

previstos

Centros

11

Fin del objetivo primario

nov 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2013.

Qué mide

Pharmacokinetic (PK) Parameter: AUCtau of EVG (Predose and up to 12 hours postdose on Day 10) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to \<18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA \< 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA \> 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA \> 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to \< 18 years old) containing Part B only.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01923311), actualizada en jul 2018.