A two part, open-label study to evaluate the safety and effectiveness ombitasvir/paritaprevir/ritonavir with and without dasabuvir given with or without a drug called ribavirin in people with both hepatitis C virus genotype 1 or 4 infection and human immunodeficiency virus, type 1 infection.

Phase 1

• Conditions: Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics; MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-005143-24-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-24
• Study Completion: 2016-10-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 318

Inclusion Criteria

1. Male or female at least 18 years of age at the time of screening.
2. Chronic HCV infection defined as: Positive anti-HCV Ab at Screening, and HCV RNA > 1,000 IU/ml at screening.
3. Plasma HIV-1 RNA < 40 copies/mL during screening using Abbott RealTime HIV-1 assay.
4. On a stable, qualifying HIV-1 antiretroviral (ART) regimen for at least 8 weeks prior to screening. The HIV-1 ART regimen must include at least one of the following ARV agents:
• Atazanavir (ATV) PO QD coadministered with ritonavir (RTV) PO QD
• Darunavir (DRV) PO QD coadministered with ritonavir (RTV) PO QD (for all subjects in Part 1b and genotype 4 subjects in Part 2 only)
• Raltegravir (RAL) PO BID
• Dolutegravir (DTG) PO QD or PO BID (Part 2 only)
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 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Positive test result at screening for Hepatitis B surface antigen (HBsAg).
2. Evidence of HCV genotype other than GT 1 or GT 4 during screening.
3. Receipt of any other investigational or commercially available anti-HCV agents (e.g., telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon, (including pegIFN), SOF and RBV.
4. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or RBV.
5. Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

Study & Design

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