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

13 novembre 2013 aggiornato da: 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

Panoramica dello studio

Stato

Terminato

Condizioni

Infezioni da HIV

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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

The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L
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.
Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT > DAIDS Grade 1
Acute/previous mycobacterial or invasive fungal infection requiring therapy or prophylaxis with drugs interfering with or significantly affected by the cytochrome P450 system
Use of investigational medications within 30 days before study entry or during the trial.
Use of concomitant drugs that may significantly reduce plasma levels of the study medications.
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
Patients currently treated with systemic ant-cancer chemotherapy
Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator.
In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Lasso di tempo
The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3. Lasso di tempo: day 8	day 8

Misure di risultato secondarie

Misura del risultato	Lasso di tempo
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 Lasso di tempo: up to week 5	up to week 5
Change from baseline in viral load at each visit Lasso di tempo: up to week 9	up to week 9
Change from baseline in CD4+ cell counts at each visit Lasso di tempo: up to week 9	up to week 9
Time averaged change from baseline in viral load through Days 8 and 35 Lasso di tempo: up to week 5	up to week 5
Number of reverse transcriptase (RT) mutations at baseline Lasso di tempo: up to week 5	up to week 5
Number of NNRTI resistance-associated mutations at baseline (refer to Appendix 10.4) Lasso di tempo: 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 Lasso di tempo: up to week 5	up to week 5
The inhibitory quotient and minimum measured concentration of the analyte in plasma (Cmin) Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: up to week 5	up to week 5
Maximum measured concentration of the analyte in plasma (Cmax) Lasso di tempo: up to week 5	up to week 5
Changes in total cholesterol, LDL, HDL and triglycerides from baseline to days 8 and 35 Lasso di tempo: up to week 9	up to week 9
Incidence of rash, hepatic events, and CNS adverse events Lasso di tempo: up to week 9	up to week 9
Incidence of any adverse events (treatment related and unrelated) Lasso di tempo: up to week 9	up to week 9
Incidence of laboratory test abnormalities Lasso di tempo: up to week 9	up to week 9
Incidence of serious adverse events (including AIDS-defining events) Lasso di tempo: up to week 9	up to week 9
Incidence of ≥ DAIDS 2 Grade elevation in ALT/AST Lasso di tempo: up to week 9	up to week 9
Incidence of AEs leading to discontinuation from the study Lasso di tempo: up to week 9	up to week 9

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2006

Completamento primario (Effettivo)

1 settembre 2007

Date di iscrizione allo studio

Primo inviato

20 febbraio 2006

Primo inviato che soddisfa i criteri di controllo qualità