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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.

NCT01565889 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-10-01

Study results available
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Summary

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.

Conditions

  • Hepatitis C
  • HIV

Interventions

DRUG

SOF

Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily

DRUG

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

DRUG

EFV

Efavirenz (EFV) 600 mg tablet administered orally once daily

DRUG

ZDV/3TC

Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily

DRUG

ATV

Atazanavir (ATV) 400 mg tablet administered orally once daily

DRUG

Ritonavir

Ritonavir (RTV) 100 mg tablet administered orally once daily

DRUG

FTC/TDF

FTC/TDF (200/300 mg) FDC tablet administered orally once daily

DRUG

DRV

Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily

DRUG

RAL

Raltegravir (RAL) 400 mg administered administered orally twice daily

DRUG

PEG

Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection

DRUG

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)

Sponsors & Collaborators

Principal Investigators

  • Anuj Gaggar, MD/PhD · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • Puerto Rico

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565889 on ClinicalTrials.gov