A study with sofosbuvir and ribavirin in patients co-infected with HIV and HCV

• Conditions: Hepatitis C Virus Infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004154-28-DE
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-18
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Male or female, age = 18 years with chronic HCV and HIV-1 infection
3. HCV RNA > 1 x 104 IU/mL at Screening
4. Infection with HCV genotype 1, 2, 3, or 4 as determined at Screening
5. HIV-1 infection confirmed with positive ELISA and Western blot at Screening (if necessary)
6. The subject’s medical records must be sufficient to be categorized on IFN eligibility or prior treatment with PEG/RBV into one of the following categories as defined in Section 6.4.2:
a) Treatment Naïve - IFN-eligible (genotypes 1, 2, 3 and 4)
b) Treatment Naïve - IFN-ineligible (genotypes 1, 2, 3 and 4)
c) Treatment Experienced - IFN Intolerant (genotypes 2 and 3)
d) Treatment Experienced - Non-Response (genotypes 2 and 3)
e) Treatment Experienced - Relapse/Breakthrough (genotypes 2and 3)
7. Confirmation of chronic HCV infection
8. Ability to determine the presence/absence of cirrhosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 243
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1. Non-genotype 1/2/3/4 or mixed genotype at Screening
2. Genotype 1 or 4 with prior treatment for HCV
3. Poor control with ARV regimen requiring a possible dose modification of therapy within 4 weeks of SOF dosing
4. Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase.
5. Pregnant or nursing female or male with pregnant female partner
6. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, a1 antitrypsin deficiency, cholangitis)
7. A new AIDS-defining condition diagnosed within 30 days prior to screening
8. Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Baseline
9. Infection with hepatitis B virus (HBV)
10. Contraindication to RBV therapy
11. History of malignancy diagnosed or treated within 5 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after cessation of therapy).;Timepoint(s) of evaluation of this end point: 12 Weeks post last dose of study drug.;Main Objective: The primary objectives of this study are:<br>• To determine the efficacy of treatment with SOF + RBV as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)<br>• To evaluate the safety and tolerability of SOF + RBV as assessed by review of the accumulated safety data, including HIV-RNA and CD4 T-cell percent;Secondary Objective: The secondary objectives of this study are as follows:<br>• To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)<br>• To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation<br>• To evaluate the emergence of viral resistance to SOF during treatment and after treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with: HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); HCV RNA < LLOQ on-treatment virologic failure, and change in HCV RNA from baseline through Week 8.;Timepoint(s) of evaluation of this end point: 4 and 24 Weeks post last dose of study drug.