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

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2012-004154-28-GB
• Date of registration: 11/02/2013
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences Inc
• Public title: A study with sofosbuvir and ribavirin in patients co-infected with HIV and HCV
• Scientific title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects - PHOTON 2
• Date of first enrolment: 15/02/2013
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004154-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, France, Germany, Italy, Portugal, Spain, United Kingdom

Contacts

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc

• Name: Medical Monitor
• Affiliation: Gilead Sciences Inc

Key inclusion & exclusion criteria

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 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Hepatitis C Virus Infection
MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: Sofosbuvir
Product Code: GS-7977
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: GS-7977
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Ribasphere
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ribavirin
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: The secondary objectives of this study are as follows:
• To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
• To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
• To evaluate the emergence of viral resistance to SOF during treatment and after treatment discontinuation

Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA

Main Objective: The primary objectives of this study are:
• 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)
• 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

Timepoint(s) of evaluation of this end point: 12 Weeks post last dose of study drug.

Secondary Outcome(s)

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.

Secondary ID(s)

GS-US-334-0124

Source(s) of Monetary Support

Gilead Sciences Inc

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 06/08/2015
• Date Completed: 10/07/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004154-28/results