- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00612755
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4
A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.
The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.
In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.
The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.
Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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-
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Barcelona, Spania, 08025
- Hospital Santa Creu i Sant Pau
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Cádiz, Spania, 11009
- Hospital Puerta del Mar
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Granada, Spania, 18013
- Hospital Clinico Universitario San Cecilio
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Madrid, Spania, 28040
- Hospital Clinico San Carlos
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Madrid, Spania, 28046
- Hospital La Paz
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Madrid, Spania, 28041
- Hospital 12 de Octubre
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Sevilla, Spania, 41013
- Hospital Virgen Del Rocio
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Sevilla, Spania, 41014
- Hospital De Valme
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Sevilla, Spania, 41008
- Hospital Virgen Macarena
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Valencia, Spania, 46014
- Consorcio Hospital General
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Valladolid, Spania, 47011
- Hospital Clínico de Valladolid
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Alava
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Vitoria, Alava, Spania, 01009
- Hospital de Txagorritxu
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spania, 08907
- Hospital de Bellvitge
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Cádiz
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Jerez de la Frontera, Cádiz, Spania, 11407
- Hospital de Jerez
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Gran Canaria
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Las Palmas, Gran Canaria, Spania, 35016
- Hospital Insular
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Guipúzcoa
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San Sebastián, Guipúzcoa, Spania, 20014
- Hospital de Donostia
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La Coruña
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Santiago, La Coruña, Spania, 15705
- Complejo Hospitalario Universitario
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Madrid
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Alcorcón, Madrid, Spania, 28922
- Fundacion Hospital de Alcorcon
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Mallorca
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Palma de Mallorca, Mallorca, Spania, 07014
- Hospital Son Dureta
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
- RNA-HCV positive at 48 week before study and genotype 1 or 4.
- HIV-1 positive: ELISA y Western-blot.
- Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion Criteria:
- Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
- Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
- More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 2
|
|
Eksperimentell: 1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
|
Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
% of patients with RNA-HCV undetectable
Tidsramme: at 48 week of study (24 weeks after the end of treatment period of trial).
|
at 48 week of study (24 weeks after the end of treatment period of trial).
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
% of percentage of patients with RNA-HCV undetectable
Tidsramme: 24 weeks of trial period
|
24 weeks of trial period
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: José Hernández-Quero, Dr, Hospital Clinico Universitario San Cecilio
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Hepatitt
- Hepatitt C
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Ribavirin
- Peginterferon alfa-2a
Andre studie-ID-numre
- Extrados
- 2004-004948-45
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. .
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