A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)
4. september 2015 oppdatert av: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies
This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks.
Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.
Studietype
Intervensjonell
Registrering (Faktiske)
352
Fase
- Fase 3
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
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patient must be HIV positive with HIV RNA values that are within ranges required by the study
- Patient must have documented failure of certain antiretroviral therapy
- Patient must be on the same antiretroviral therapy for at least the past two months
Exclusion Criteria:
- Patient is less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 2
Placebo
|
Placebo b.i.d.
p.o. with optimized background therapy.
Treatment period of 48 weeks.
|
|
Eksperimentell: 1
raltegravir potassium
|
Raltegravir 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy.
Treatment period of 48 weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
Tidsramme: 16 Weeks
|
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16
|
16 Weeks
|
|
Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
Tidsramme: 48 Weeks
|
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48
|
48 Weeks
|
|
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Tidsramme: 156 Weeks
|
Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156
|
156 Weeks
|
|
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
Tidsramme: 240 Weeks
|
Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240
|
240 Weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
Tidsramme: 16 Weeks
|
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16
|
16 Weeks
|
|
Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
Tidsramme: 48 Weeks
|
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48
|
48 Weeks
|
|
Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Tidsramme: 156 weeks
|
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156
|
156 weeks
|
|
Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
Tidsramme: 240 weeks
|
Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240
|
240 weeks
|
|
Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
Tidsramme: 156 weeks
|
For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response.
Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).
|
156 weeks
|
|
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16
Tidsramme: Baseline and Week 16
|
Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)
|
Baseline and Week 16
|
|
Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
Tidsramme: Baseline and Week 48
|
Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)
|
Baseline and Week 48
|
|
Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
Tidsramme: Baseline and Week 156
|
Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)
|
Baseline and Week 156
|
|
Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
Tidsramme: Baseline and Week 240
|
Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)
|
Baseline and Week 240
|
|
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
Tidsramme: Baseline and Week 16
|
Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)
|
Baseline and Week 16
|
|
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Tidsramme: Baseline and Week 48
|
Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)
|
Baseline and Week 48
|
|
Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Tidsramme: Baseline and Week 156
|
Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)
|
Baseline and Week 156
|
|
Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
Tidsramme: Baseline and Week 240
|
Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)
|
Baseline and Week 240
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54. doi: 10.1056/NEJMoa0708975.
- Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65. doi: 10.1056/NEJMoa0708978.
- Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
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
1. februar 2006
Primær fullføring (Faktiske)
1. august 2007
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
14. februar 2006
Først innsendt som oppfylte QC-kriteriene
15. februar 2006
Først lagt ut (Anslag)
17. februar 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
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
- Antiretrovirale midler
- HIV-integrasehemmere
- Integrasehemmere
- Raltegravir kalium
Andre studie-ID-numre
- 0518-018
- 2005_096
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. .