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. juli 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
2 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Raltegravir Film-coated Tablet
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Andre navn:
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
|
|
Eksperimentell: 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
|
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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With at Least One Clinical Adverse Experience
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. november 2012
Primær fullføring (Faktiske)
11. desember 2013
Studiet fullført (Faktiske)
11. desember 2013
Datoer for studieregistrering
Først innsendt
26. oktober 2012
Først innsendt som oppfylte QC-kriteriene
26. oktober 2012
Først lagt ut (Anslag)
30. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2018
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- HIV-infeksjoner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- HIV-integrasehemmere
- Integrasehemmere
- Raltegravir kalium
- Antiretrovirale midler
Andre studie-ID-numre
- 0518-248
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiedata/dokumenter
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .