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A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

23 luglio 2018 aggiornato da: Merck Sharp & Dohme LLC

A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents

This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).

As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use

of raltegravir in the pediatric HIV-infected population in Russia.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Fase 2

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 2 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • HIV positive
  • Weight of at least 7 kg
  • HIV RNA ≥1000 copies/mL within 45 days before study treatment
  • Participants of reproductive potential and sexually active agree to remain

abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.

Exclusion Criteria:

  • Females pregnant or breast-feeding, or expecting to conceive or donate eggs

during the study; males planning to impregnate or provide sperm donation

during the study

  • Use of any non-antiretroviral (ART) investigational agents within one month before study treatment
  • Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C
  • Prior or current use of raltegravir
  • Use of another experimental HIV-integrase inhibitor
  • History or current evidence of any condition, therapy, laboratory

abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study

  • Requires or is anticipated to require any prohibited medications
  • Use of immunosuppressive therapy within 30 days before beginning

raltegravir study treatment; short courses of corticosteroids are permitted.

  • History of malignancy
  • Current treatment for active tuberculosis infection
  • Use of recreational or illicit drugs or a recent history (within the

last year) of drug or alcohol abuse or dependence

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Raltegravir Film-coated Tablet
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Droga: Raltegravir Film-coated Tablet
Altri nomi:
  • MK-0518
  • ISENTRESS®
Droga: Other Anti-Retroviral Therapy
At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
Sperimentale: Raltegravir Chewable Tablet
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
Droga: Other Anti-Retroviral Therapy
At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
Droga: Raltegravir Chewable Tablet
Altri nomi:
  • MK-0518
  • ISENTRESS®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With at Least One Clinical Adverse Experience
Lasso di tempo: Up to Week 26
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Up to Week 26
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
Lasso di tempo: Up to Week 24
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Up to Week 24
Percentage of Participants With at Least One Laboratory Adverse Experience
Lasso di tempo: Up to Week 26
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Up to Week 26
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
Lasso di tempo: Up to Week 24
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Up to Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
Lasso di tempo: Baseline and Week 24
This outcome is a measure of immunological response to treatment
Baseline and Week 24
Change From Baseline in CD4 Cell Percentage
Lasso di tempo: Baseline and Week 24
This outcome is a measure of immunological response to treatment
Baseline and Week 24
Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL
Lasso di tempo: Week 24
This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Week 24
Percentage of Participants Achieving HIV RNA <40 Copies/mL
Lasso di tempo: Week 24
This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Week 24
Percentage of Participants Achieving HIV RNA <200 Copies/mL
Lasso di tempo: Week 24
This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
Week 24

Collaboratori e investigatori

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

Sponsor

Merck Sharp & Dohme LLC

Collaboratori

Covance

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 (Effettivo)

16 novembre 2012

Completamento primario (Effettivo)

11 dicembre 2013

Completamento dello studio (Effettivo)

11 dicembre 2013

Date di iscrizione allo studio

Primo inviato

26 ottobre 2012

Primo inviato che soddisfa i criteri di controllo qualità

26 ottobre 2012

Primo Inserito (Stima)

30 ottobre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2018

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0518-248

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Dati/documenti di studio

  1. Sinossi CSR

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 .

Prove cliniche su Infezione da HIV

Prove cliniche su Raltegravir Film-coated Tablet

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Lithuania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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