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.
NCT ID: NCT01565889
Last Updated: 2014-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2012-03-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
EFV/FTC/TDF
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
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.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
EFV
Efavirenz (EFV) 600 mg tablet administered orally once daily
ZDV/3TC
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
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.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
ATV
Atazanavir (ATV) 400 mg tablet administered orally once daily
Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
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.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
DRV
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
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.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
RAL
Raltegravir (RAL) 400 mg administered administered orally twice daily
Part B: SOF+PEG+RBV
Participants will receive SOF+PEG+RBV for 12 weeks.
SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
PEG
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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SOF
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
EFV/FTC/TDF
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
EFV
Efavirenz (EFV) 600 mg tablet administered orally once daily
ZDV/3TC
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
ATV
Atazanavir (ATV) 400 mg tablet administered orally once daily
Ritonavir
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDF
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
DRV
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
RAL
Raltegravir (RAL) 400 mg administered administered orally twice daily
PEG
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Anuj Gaggar, MD/PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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References
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Rodriguez-Torres M, Gaggar A, Shen G, Kirby B, Svarovskaia E, Brainard D, Symonds WT, McHutchison JG, Gonzalez M, Rodriguez-Orengo J. Sofosbuvir for chronic hepatitis C virus infection genotype 1-4 in patients coinfected with HIV. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):543-9. doi: 10.1097/QAI.0000000000000516.
Other Identifiers
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P7977-1910
Identifier Type: -
Identifier Source: org_study_id
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