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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. November 2013 aktualisiert von: 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

Studienübersicht

Status

Beendet

Bedingungen

HIV-Infektionen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung

Phase

Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Doppelt

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Zeitfenster
The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3. Zeitfenster: day 8	day 8

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2006

Primärer Abschluss (Tatsächlich)

1. September 2007

Studienanmeldedaten

Zuerst eingereicht

20. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat