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.
Status and phase
Completed
Phase 2
Phase 1
Conditions
Hepatitis C
HIV
Treatments
Drug: RBV
Drug: RAL
Drug: PEG
Drug: EFV/FTC/TDF
Drug: Ritonavir
Drug: ATV
Drug: SOF
Drug: EFV
Drug: DRV
Drug: ZDV/3TC
Drug: FTC/TDF
Details and patient eligibility
About
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.
Enrollment
52 patients
Sex
All
Ages
21+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
52 participants in 6 patient groups
Part A: SOF+EFV/FTC/TDF (Cohort 1)
Experimental group
Description:
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.
Treatment:
Drug: SOF
Drug: EFV/FTC/TDF
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
Experimental group
Description:
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.
Treatment:
Drug: ZDV/3TC
Drug: EFV
Drug: SOF
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
Experimental group
Description:
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.
Treatment:
Drug: FTC/TDF
Drug: ATV
Drug: SOF
Drug: Ritonavir
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
Experimental group
Description:
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.
Treatment:
Drug: FTC/TDF
Drug: SOF
Drug: DRV
Drug: Ritonavir
Part A: SOF+RAL+FTC/TDF (Cohort 5)
Experimental group
Description:
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.
Treatment:
Drug: FTC/TDF
Drug: RAL
Drug: SOF
Part B: SOF+PEG+RBV
Experimental group
Description:
Participants will receive SOF+PEG+RBV for 12 weeks.
Treatment:
Drug: RBV
Drug: SOF
Drug: PEG
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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