Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
25. september 2014 oppdatert av: Gilead Sciences
Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir and Emtricitabine; Raltegravir, Tenofovir and Emtricitabine in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection.
Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
52
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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San Juan, Puerto Rico, 00927
- Fundacion De Investigacion de Diego
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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
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
- Confirmation of Chronic HCV infection
- Confirmation of Chronic HIV-1 infection
- On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
- Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
- Subjects must be naive to treatment for chronic HCV infection
Exclusion Criteria:
- Known or suspected cirrhosis
- History of any other clinically significant chronic liver disease
- A history consistent with decompensated liver disease.
- Use of any prohibited medications as defined by the protocol
- Pregnant or nursing female or male with pregnant female partner
- Contraindication to PEG or RBV therapy (for Part B)
- Clinically relevant drug or alcohol abuse
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 |
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Eksperimentell: Part A: SOF+EFV/FTC/TDF (Cohort 1)
Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions.
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Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
Andre navn:
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Eksperimentell: Part A: SOF+EFV+ZDV/3TC (Cohort 2)
Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days.
Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach.
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Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
Efavirenz (EFV) 600 mg tablet administered orally once daily
Andre navn:
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
Andre navn:
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Eksperimentell: Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food.
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Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
Atazanavir (ATV) 400 mg tablet administered orally once daily
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
Andre navn:
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Eksperimentell: Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food.
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Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
Andre navn:
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
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Eksperimentell: Part A: SOF+RAL+FTC/TDF (Cohort 5)
Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days.
Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food.
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Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
Andre navn:
Raltegravir (RAL) 400 mg administered administered orally twice daily
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Eksperimentell: Part B: SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
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Ribavirin (RBV) tabletter administrert oralt i en delt daglig dose i henhold til vektbaserte doseringsanbefalinger i pakningsvedlegget (< 75 kg = 1000 mg og ≥ 75 kg = 1200 mg)
Andre navn:
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andre navn:
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Forekomst av uønskede hendelser som fører til permanent seponering av studiemedikament(er)
Tidsramme: Inntil 12 uker
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Prosentandelen av deltakere som avbrøt et studielegemiddel på grunn av en bivirkning ble oppsummert.
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Inntil 12 uker
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Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Tidsramme: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
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AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only. |
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
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Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Tidsramme: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
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Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only. |
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
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Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Tidsramme: Posttreatment Week 12
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only. |
Posttreatment Week 12
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Tidsramme: Posttreatment Weeks 4 and 24
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SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure were collected for participants in Part B only. |
Posttreatment Weeks 4 and 24
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Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Tidsramme: Posttreatment Weeks 4 and 24
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Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure were collected for participants in Part B only. |
Posttreatment Weeks 4 and 24
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Part B: On-treatment HCV RNA
Tidsramme: Up to 8 weeks
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Data for this outcome measure were collected for participants in Part B only.
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Up to 8 weeks
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Part B: On-treatment HIV RNA
Tidsramme: Up to 8 weeks
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Data for this outcome measure were collected for participants in Part B only.
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Up to 8 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Anuj Gaggar, MD/PhD, Gilead Sciences
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.
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. mars 2012
Primær fullføring (Faktiske)
1. august 2013
Studiet fullført (Faktiske)
1. november 2013
Datoer for studieregistrering
Først innsendt
27. mars 2012
Først innsendt som oppfylte QC-kriteriene
28. mars 2012
Først lagt ut (Anslag)
29. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. september 2014
Sist bekreftet
1. september 2014
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
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Antimetabolitter
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- Ribavirin
- Ritonavir
Andre studie-ID-numre
- P7977-1910
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. .