Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Phase II Study on the Antiviral Activity and Safety of BILR 355 BS in HIV-1 Infected, NNRTI-treated Patients

13 de noviembre de 2013 actualizado por: Boehringer Ingelheim

Randomised, Double-blind, Placebo-controlled 7 Day Monotherapy Phase IIa Study to Evaluate the Antiviral Activity and Safety of Increasing Doses of Oral Administered RTV-boosted BILR 355 BS (75 mg and 150 mg Twice Daily) in HIV-1-infected, NNRTI-experienced Patients, Followed by 28 Day Combination Therapy With Tipranavir or Lopinavir Based HAART-regimen

The general aim is to evaluate the antiviral activity and safety of increasing doses of oral administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected, NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or Lopinavir based HAART-regimen

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción

36

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • Boehringer Ingelheim Investigational Site
      • Bochum, Alemania
        • Boehringer Ingelheim Investigational Site
      • Bonn, Alemania
        • Boehringer Ingelheim Investigational Site
      • Erlangen, Alemania
        • Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Alemania
        • Boehringer Ingelheim Investigational Site
      • Hamburg, Alemania
        • Boehringer Ingelheim Investigational Site
      • Hannover, Alemania
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, Alemania
        • Boehringer Ingelheim Investigational Site
      • Mainz, Alemania
        • Boehringer Ingelheim Investigational Site
      • Munchen, Alemania
        • Boehringer Ingelheim Investigational Site
      • Ulm, Alemania
        • Boehringer Ingelheim Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation.
  2. HIV-1 infected males or females >= 18 years of age.
  3. History of NNRTI based HAART >= 8 weeks and at least one, but not more than 3 NNRTI-associated resistance mutations by current genotype
  4. TPV/r or LPV/r susceptible
  5. CD4+ T lymphocyte count >= 100 cells/?l.

7. HIV-1 viral load >= 2000 copies/mL at screening. 8. Karnofsky score >= 70 9. Based on the antiviral resistance profile of the patients virus, the investigator must be able to construct a background HAART treatment regimen (OBR) such that the patient will receive 3 effective ARV drugs, in addition to his study medication.

10. Acceptable screening laboratory values (Visit 1) that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: Absolute neutrophil count (ANC) >750/mm3 Hemoglobin >= 10 g/dL Platelet count >99,000/mm3 AST, ALT , and alkaline phosphatase < 2.5xULN >= DAIDS Grade 1) Total bilirubin <2.5xULN Serum amylase <1.5xULN 11. Acceptable medical history, as assessed by the investigator, with chest x-ray results and ECG within 1 year of study participation.

12. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system 13. A prior AIDS defining event, excluding mycobacterial and invasive fungal infections, is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection) for at least 12 weeks before screening (Visit 1). Note that prior oral thrush, candida esophagitis and cutaneous candida is acceptable.

Exclusion Criteria:

  1. The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L

  2. Female patients of child-bearing potential who:

    have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception.

  3. Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT > DAIDS Grade 1
  4. Acute/previous mycobacterial or invasive fungal infection requiring therapy or prophylaxis with drugs interfering with or significantly affected by the cytochrome P450 system
  5. Use of investigational medications within 30 days before study entry or during the trial.
  6. Use of concomitant drugs that may significantly reduce plasma levels of the study medications.
  7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
  8. Patients currently treated with systemic ant-cancer chemotherapy
  9. Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
  10. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3.
Periodo de tiempo: day 8
day 8

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Virologic response at Day 8 and Day 35 using <400 copies/mL and 0.5, 1 and 1.5 log10 reduction in viral load from baseline
Periodo de tiempo: up to week 5
up to week 5
Change from baseline in viral load at each visit
Periodo de tiempo: up to week 9
up to week 9
Change from baseline in CD4+ cell counts at each visit
Periodo de tiempo: up to week 9
up to week 9
Time averaged change from baseline in viral load through Days 8 and 35
Periodo de tiempo: up to week 5
up to week 5
Number of reverse transcriptase (RT) mutations at baseline
Periodo de tiempo: up to week 5
up to week 5
Number of NNRTI resistance-associated mutations at baseline (refer to Appendix 10.4)
Periodo de tiempo: up to week 5
up to week 5
The presence of specific RT mutations (both in the list of NNRTI mutations and not in the list for exploratory purposes) at baseline
Periodo de tiempo: up to week 5
up to week 5
The inhibitory quotient and minimum measured concentration of the analyte in plasma (Cmin)
Periodo de tiempo: up to Day 8
up to Day 8
Exploration of mutations that emerge with exposure to BILR 355 BS to determine the effect on both viral load and IC50 fold change from reference
Periodo de tiempo: up to week 5
up to week 5
Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours post-dose (AUC0-12h)
Periodo de tiempo: up to week 5
up to week 5
Maximum measured concentration of the analyte in plasma (Cmax)
Periodo de tiempo: up to week 5
up to week 5
Changes in total cholesterol, LDL, HDL and triglycerides from baseline to days 8 and 35
Periodo de tiempo: up to week 9
up to week 9
Incidence of rash, hepatic events, and CNS adverse events
Periodo de tiempo: up to week 9
up to week 9
Incidence of any adverse events (treatment related and unrelated)
Periodo de tiempo: up to week 9
up to week 9
Incidence of laboratory test abnormalities
Periodo de tiempo: up to week 9
up to week 9
Incidence of serious adverse events (including AIDS-defining events)
Periodo de tiempo: up to week 9
up to week 9
Incidence of ≥ DAIDS 2 Grade elevation in ALT/AST
Periodo de tiempo: up to week 9
up to week 9
Incidence of AEs leading to discontinuation from the study
Periodo de tiempo: up to week 9
up to week 9

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2006

Finalización primaria (Actual)

1 de septiembre de 2007

Fechas de registro del estudio

Enviado por primera vez

20 de febrero de 2006

Primero enviado que cumplió con los criterios de control de calidad

20 de febrero de 2006

Publicado por primera vez (Estimar)

22 de febrero de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de noviembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

13 de noviembre de 2013

Última verificación

1 de noviembre de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1188.31

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir