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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Studietyp
Interventionell
Inskrivning (Faktisk)
52
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
San Juan, Puerto Rico, 00927
- Fundacion De Investigacion de Diego
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
Andra namn:
|
|
Experimentell: 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.
|
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
Efavirenz (EFV) 600 mg tablet administered orally once daily
Andra namn:
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
Andra namn:
|
|
Experimentell: 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.
|
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
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
Andra namn:
|
|
Experimentell: 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.
|
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
Andra namn:
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
|
|
Experimentell: 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.
|
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
Andra namn:
Raltegravir (RAL) 400 mg administered administered orally twice daily
|
|
Experimentell: Part B: SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
|
Ribavirin (RBV) tabletter administreras oralt i en uppdelad daglig dos enligt viktbaserade doseringsrekommendationer på bipacksedeln (< 75 kg = 1 000 mg och ≥ 75 kg = 1 200 mg)
Andra namn:
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Andra namn:
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Förekomst av biverkningar som leder till permanent avbrytande av studieläkemedel
Tidsram: Upp till 12 veckor
|
Andelen deltagare som avbröt något studieläkemedel på grund av en biverkning sammanfattades.
|
Upp till 12 veckor
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Tidsram: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
|
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
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Tidsram: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
|
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
|
|
Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Tidsram: Posttreatment Week 12
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Tidsram: Posttreatment Weeks 4 and 24
|
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
|
|
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Tidsram: Posttreatment Weeks 4 and 24
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part B: On-treatment HCV RNA
Tidsram: Up to 8 weeks
|
Data for this outcome measure were collected for participants in Part B only.
|
Up to 8 weeks
|
|
Part B: On-treatment HIV RNA
Tidsram: Up to 8 weeks
|
Data for this outcome measure were collected for participants in Part B only.
|
Up to 8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Anuj Gaggar, MD/PhD, Gilead Sciences
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 augusti 2013
Avslutad studie (Faktisk)
1 november 2013
Studieregistreringsdatum
Först inskickad
27 mars 2012
Först inskickad som uppfyllde QC-kriterierna
28 mars 2012
Första postat (Uppskatta)
29 mars 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit
- Hepatit A
- Hepatit C
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Antimetaboliter
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- Ribavirin
- Ritonavir
Andra studie-ID-nummer
- P7977-1910
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .