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TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

3 marzo 2016 aggiornato da: Tibotec Pharmaceuticals, Ireland

A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Over the past decade, anti-human immunodeficiency virus (HIV) drugs have been introduced sequentially for use in the clinic. Currently, patients are routinely being treated with 3 or 4 drug combinations including nucleoside/tide analogue reverse transcriptase inhibitors (NRTIs/NtRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and/or fusion inhibitors. New potent antiretroviral (ARV) compounds that work in people whose HIV-1 virus is resistant to available drugs are urgently needed. This is a Phase III, randomized (study medication is assigned by chance), double-blind (neither the study physician nor the patient knows the name of the study assigned medication), double-dummy, active-controlled trial to compare the effectiveness, safety, and ability to tolerate TMC278 versus efavirenz (EFV). The study will last for 104 weeks which includes a screening period of 4 weeks, a 96-week treatment period, followed by a 4 week follow-up period. Patients will be randomly assigned (like tossing a coin) to TMC278 or to efavirenz in combination with two other anti-HIV drugs of the class nucleoside/nucleotide reverse transcriptase inhibitors. The hypothesis to be provided in this study is that the investigational drug TMC278 will perform just like efavirenz (EFV) in terms of antiviral effectiveness (i.e., suppressing of the plasma viral load to a level < 50 HIV-1 RNA (ribonucleic acid) copies/mL, in ARV-naïve HIV-infected patients. During the trial, patients' health will be monitored by physical examination, interview to assess health and well being, and laboratory testing on blood and urine samples. Experimental Group: One tablet of TMC278 25 mg daily; plus efavirenz (EFV) placebo; plus 2 nucleoside/nucleotide reverse transcriptase inhibitors; Control Group: One tablet of Placebo daily that looks just like TMC278 plus EFV 600 mg daily plus 2 nucleoside/nucleotide reverse transcriptase inhibitors for 104 weeks.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

680

Fase

  • Fase 3

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

  • Australia
      • Darlinghurst, Australia
      • Prahran, Australia
      • Surry Hills, Australia
  • Belgio
      • Antwerpen, Belgio
      • Brussels, Belgio
      • Gent, Belgio
      • Leuven, Belgio
  • Brasile
      • Campinas, Brasile
      • Distrito Barao Geraldo-Campina, Brasile
      • Pinheiros, Brasile
      • Recife, Brasile
      • Sao Paulo, Brasile
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Chile
      • Providencia, Chile
      • Santiago, Chile
  • Cina
      • Beijing, Cina
      • Guangzhou, Cina
      • Shanghai, Cina
  • Costa Rica
      • San Jose, Costa Rica
  • Federazione Russa
      • Moscow N/A, Federazione Russa
      • Saint-Petersburg, Federazione Russa
      • Smolensk, Federazione Russa
      • Voronezh, Federazione Russa
  • Francia
      • Clamart, Francia
      • Le Kremlin Bicetre, Francia
      • Montpellier, Francia
      • Paris, Francia
  • Germania
      • Berlin, Germania
      • Essen, Germania
      • Frankfurt, Germania
      • Hamburg, Germania
      • Hannover, Germania
      • Köln, Germania
      • Mannheim, Germania
  • India
      • Chennai, India
      • Nagpur, India
  • Messico
      • Guadalajara N/A, Messico
      • Mexico City, Messico
  • Panama
      • Panama, Panama
      • Panama City N/A, Panama
  • Porto Rico
      • San Juan, Porto Rico
  • Portogallo
      • Porto, Portogallo
  • Regno Unito
      • London, Regno Unito
      • Manchester, Regno Unito
  • Spagna
      • Barcelona, Spagna
      • Barcelona N/A, Spagna
      • Elche, Spagna
      • Madrid, Spagna
  • Stati Uniti
    • California
      • Long Beach, California, Stati Uniti
      • Los Angeles, California, Stati Uniti
      • San Francisco, California, Stati Uniti
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti
    • Florida
      • Atlantis, Florida, Stati Uniti
      • Miami, Florida, Stati Uniti
      • Miami Beach, Florida, Stati Uniti
      • Orlando, Florida, Stati Uniti
      • Tampa, Florida, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
    • Kentucky
      • Lexington, Kentucky, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
      • Springfield, Massachusetts, Stati Uniti
    • Michigan
      • Detroit, Michigan, Stati Uniti
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti
    • New Jersey
      • Newark, New Jersey, Stati Uniti
    • New York
      • Bronx, New York, Stati Uniti
      • Flushing, New York, Stati Uniti
      • New York, New York, Stati Uniti
      • Rochester, New York, Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
      • Longview, Texas, Stati Uniti
  • Sud Africa
      • Bloemfontein, Sud Africa
      • Cape Town, Sud Africa
      • Dundee, Sud Africa
      • Johannesburg, Sud Africa
      • Pretoria N/A, Sud Africa
      • Westdene Johannesburg Gauteng, Sud Africa
  • Tailandia
      • Bangkok, Tailandia

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

Da 18 anni a 99 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patient with documented HIV-1 infection
  • Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
  • Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
  • Patient's virus is sensitive to the 2 nucleoside/nucleotide reverse transcriptase inhibitors chosen for treatment
  • Patient agrees not to start ART before the baseline visit
  • Patient is HLA-B*5701 negative in case abacavir is included in the patient's treatment regimen.

Exclusion Criteria:

  • Previous use of ANY ARV drug for ANY length of time
  • Any documented evidence of NNRTI resistance associated mutations in patient's HIV
  • Category C AIDS defining illness, except, Stable Kaposi Sarcoma Wasting syndrome if not progressive
  • Pneumocystis carinii pneumonia (PCP) that is considered not cured
  • Active TB
  • Allergy or hypersensitivity to study or background ARTs
  • Specific grade 3 or 4 toxicity
  • Kidney impairment: calculated creatinine clearance <50 ml/min

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 002
efavirenz 600 mg tablet once daily for 96 weeks
Droga: efavirenz
600 mg tablet once daily for 96 weeks
Sperimentale: 001
TMC278 25 mg tablet once daily for 96 weeks
Droga: TMC278
Compressa da 25 mg una volta al giorno per 96 settimane

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48
Lasso di tempo: Week 48
Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).
Week 48

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Variazione media dal basale alla settimana 48 e alla settimana 96 nella conta assoluta e relativa delle cellule CD4+ (utilizzando dati imputati)
Lasso di tempo: Basale, settimana 48 e settimana 96
La variazione rispetto al basale nella conta delle cellule CD4+ è stata imputata in caso di valori mancanti: in caso di interruzione prematura, i dati sono stati imputati con il valore basale dopo l'interruzione (ad es. change=0, Non completato [NC] = Fallimento); in caso contrario è stata applicata l'ultima osservazione riportata.
Basale, settimana 48 e settimana 96
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48
Lasso di tempo: Week 48
The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol.
Week 48
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96
Lasso di tempo: Week 96
Week 96
Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96
Lasso di tempo: Week 96
Week 96
Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).
Lasso di tempo: Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz
Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit.
Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48
Lasso di tempo: Week 48
Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).
Week 48
Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96
Lasso di tempo: Week 96
Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).
Week 96
Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure
Lasso di tempo: Week 96
Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).
Week 96

Collaboratori e investigatori

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

Sponsor

Tibotec Pharmaceuticals, Ireland

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 giugno 2008

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 febbraio 2012

Date di iscrizione allo studio

Primo inviato

11 ottobre 2007

Primo inviato che soddisfa i criteri di controllo qualità

11 ottobre 2007

Primo Inserito (Stima)

15 ottobre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 marzo 2016

Ultimo verificato

1 marzo 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR002704
  • TMC278-TIDP6-C215 (Altro identificatore: Tibotec Pharmaceuticals, Ireland)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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