DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Two Part, Open-label Study to Evaluate the Safety and Effectiveness of ABT-450/r/ABT-267 or ABT-450/r/ABT-267 and ABT-333 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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics

Intervention: ABT-450/r/ABT-267 (Drug); ABT-333 (Drug); Ribavirin (RBV) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AbbVie

Official(s) and/or principal investigator(s):
Roger Trinh, MD, Study Director, Affiliation: AbbVie

Overall contact:
Karmin Robinson-Morgan, BS, Phone: 847-935-5421, Email: karmin.y.robinson@abbvie.com

Summary

The purpose of this study is to assess the safety and efficacy of ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus Infection with Human Immunodeficiency Virus, Type 1 coinfection.

Clinical Details

Official title: A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of subjects in genotype 1 Analysis Group 1 in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical SVR12 rate for sofosbuvir plus ribavirin as reported in the PHOTON-1 study

Secondary outcome:

The percentage of subjects in genotype 1 Analysis Group 2 of Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical rate for sofosbuvir plus ribavirin

The percentage of Part 1a subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the 24-week treatment group compared to the 12-week treatment group using Fisher's exact test

The percentage of subjects of Part 1b subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the darunavir once-daily arm compared to the darunavir twice-daily arm using Fisher's exact test

The percentage of Part 1b subjects achieving sustained virologic response 12 weeks post-treatment (SVR12)

The percentage of Part 2 GT 1b cirrhotic subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in Arm F (without ribavirin) compared to Arm G (with ribavirin) using Fisher's exact test

The percentage of genotype 4 subjects in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) by arm and overall

Percentage of subjects with on treatment Hepatitis C Virus virologic failure during the Treatment Period for each arm in Part 1, set of all subjects in Part 1b, the genotype 1 Analysis Group 1 and 2 in Part 2, the GT4 Analysis Group by arm and overall

The percentage of subjects with Hepatitis C Virus post-treatment relapse (analyses performed as described for secondary endpoint 7).

Percentage of subjects with plasma HIV-1 RNA suppression at end of treatment and 12 weeks post-treatment (analyses performed as described for secondary endpoint 7) and comparison of the darunavir once-daily and twice-daily arms in Part 1b

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic HCV infection at Screening defined as: Positive anti-HCV Ab at Screening and

HCV RNA > 1,000 IU/mL at Screening.

- Plasma HIV-1 RNA <40 copies/mL during Screening using Abbott RealTime HIV-1 assay.

- On a stable qualifying human immunodeficiency virus, type 1 (HIV-1) antiretroviral

therapy regimen. Exclusion Criteria:

- Positive test result at screening for Hepatitis B surface antigen.

- Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.

- Receipt of any other investigational or commercially available anti-HCV agents (for

example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.

- Consideration by the investigator, for any reason, that the subject is an unsuitable

candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.

- Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

Locations and Contacts

Karmin Robinson-Morgan, BS, Phone: 847-935-5421, Email: karmin.y.robinson@abbvie.com

Site Reference ID/Investigator# 124574, Vancouver V6Z 2C7, Canada; Not yet recruiting
Site Reference ID/Investigator# 124574, Principal Investigator

Site Reference ID/Investigator# 124583, Berlin 13353, Germany; Not yet recruiting
Site Reference ID/Investigator# 124583, Principal Investigator

Site Reference ID/Investigator# 124587, Bonn 53127, Germany; Not yet recruiting
Site Reference ID/Investigator# 124587, Principal Investigator

Site Reference ID/Investigator# 124586, Duesseldorf 40237, Germany; Not yet recruiting
Site Reference ID/Investigator# 124586, Principal Investigator

Site Reference ID/Investigator# 124588, Hamburg 20099, Germany; Not yet recruiting
Site Reference ID/Investigator# 124588, Principal Investigator

Site Reference ID/Investigator# 124584, Wuerzburg 97080, Germany; Not yet recruiting
Site Reference ID/Investigator# 124584, Principal Investigator

Site Reference ID/Investigator# 124594, Milan 20127, Italy; Not yet recruiting
Site Reference ID/Investigator# 124594, Principal Investigator

Site Reference ID/Investigator# 124596, Milan 20157, Italy; Not yet recruiting
Site Reference ID/Investigator# 124596, Principal Investigator

Site Reference ID/Investigator# 124589, Pavia 27100, Italy; Not yet recruiting
Site Reference ID/Investigator# 124589, Principal Investigator

Site Reference ID/Investigator# 124515, Auckland 1142, New Zealand; Not yet recruiting
Site Reference ID/Investigator# 124515, Principal Investigator

Site Reference ID/Investigator# 95578, Bayamon 00959, Puerto Rico; Recruiting
Site Reference ID/Investigator# 95578, Principal Investigator

Site Reference ID/Investigator# 95575, Ponce 00717-1563, Puerto Rico; Recruiting
Site Reference ID/Investigator# 95575, Principal Investigator

Site Reference ID/Investigator# 95577, Ponce 00731, Puerto Rico; Recruiting
Site Reference ID/Investigator# 95577, Principal Investigator

Site Reference ID/Investigator# 124605, Krasnoyarsk 660049, Russian Federation; Not yet recruiting
Site Reference ID/Investigator# 124605, Principal Investigator

Site Reference ID/Investigator# 124606, Moscow 105275, Russian Federation; Not yet recruiting
Site Reference ID/Investigator# 124606, Principal Investigator

Site Reference ID/Investigator# 124603, Saint-Petersburg 190103, Russian Federation; Not yet recruiting
Site Reference ID/Investigator# 124603, Principal Investigator

Site Reference ID/Investigator# 124608, Alicante 03010, Spain; Not yet recruiting
Site Reference ID/Investigator# 124608, Principal Investigator

Site Reference ID/Investigator# 124609, Barcelona 08916, Spain; Not yet recruiting
Site Reference ID/Investigator# 124609, Principal Investigator

Site Reference ID/Investigator# 124607, Madrid 28022, Spain; Not yet recruiting
Site Reference ID/Investigator# 124607, Principal Investigator

Site Reference ID/Investigator# 124610, San sebastian 20014, Spain; Not yet recruiting
Site Reference ID/Investigator# 124610, Principal Investigator

Site Reference ID/Investigator# 124612, Edinburgh EH4 2XU, United Kingdom; Not yet recruiting
Site Reference ID/Investigator# 124612, Principal Investigator

Site Reference ID/Investigator# 124613, London SW10 9NH, United Kingdom; Not yet recruiting
Site Reference ID/Investigator# 124613, Principal Investigator

Site Reference ID/Investigator# 95592, Birmingham, Alabama 35294, United States; Recruiting
Site Reference ID/Investigator# 95592, Principal Investigator

Site Reference ID/Investigator# 95581, Tucson, Arizona 85724-5136, United States; Recruiting
Site Reference ID/Investigator# 95581, Principal Investigator

Site Reference ID/Investigator# 95580, Beverly Hills, California 90211, United States; Recruiting
Site Reference ID/Investigator# 95580, Principal Investigator

Site Reference ID/Investigator# 95591, Los Angeles, California 90036, United States; Recruiting
Site Reference ID/Investigator# 95591, Principal Investigator

Site Reference ID/Investigator# 98364, Riverside, California 92501, United States; Recruiting
Site Reference ID/Investigator# 98364, Principal Investigator

Site Reference ID/Investigator# 95599, San Diego, California 92103-8208, United States; Recruiting
Site Reference ID/Investigator# 95599, Principal Investigator

Site Reference ID/Investigator# 102936, San Francisco, California 94115, United States; Recruiting
Site Reference ID/Investigator# 102936, Principal Investigator

Site Reference ID/Investigator# 113695, San Francisco, California 94110, United States; Not yet recruiting
Site Reference ID/Investigator# 113695, Principal Investigator

Site Reference ID/Investigator# 95583, San Francisco, California 94109, United States; Recruiting
Site Reference ID/Investigator# 95583, Principal Investigator

Site Reference ID/Investigator# 95584, Aurora, Colorado 80045, United States; Recruiting
Site Reference ID/Investigator# 95584, Principal Investigator

Site Reference ID/Investigator# 102975, Norwalk, Connecticut 06850, United States; Recruiting
Site Reference ID/Investigator# 102975, Principal Investigator

Site Reference ID/Investigator# 139121, Washington, District of Columbia 20009, United States; Withdrawn

Site Reference ID/Investigator# 95585, Washington, District of Columbia 20009, United States; Recruiting
Site Reference ID/Investigator# 95585, Principal Investigator

Site Reference ID/Investigator# 136914, DeLand, Florida 32720, United States; Recruiting
Site Reference ID/Investigator# 136914, Principal Investigator

Site Reference ID/Investigator# 137990, Fort Pierce, Florida 34982, United States; Recruiting
Site Reference ID/Investigator# 137990, Principal Investigator

Site Reference ID/Investigator# 95593, Ft. Lauderdale, Florida 33311, United States; Withdrawn

Site Reference ID/Investigator# 102935, Jacksonville, Florida 32256, United States; Recruiting
Site Reference ID/Investigator# 102935, Principal Investigator

Site Reference ID/Investigator# 136912, West Palm Beach, Florida 33401, United States; Recruiting
Site Reference ID/Investigator# 136912, Principal Investigator

Site Reference ID/Investigator# 95579, Chicago, Illinois 60612, United States; Recruiting
Site Reference ID/Investigator# 95579, Principal Investigator

Site Reference ID/Investigator# 95596, Lutherville, Maryland 21093, United States; Recruiting
Site Reference ID/Investigator# 95596, Principal Investigator

Site Reference ID/Investigator# 95588, East Lansing, Michigan 48824, United States; Recruiting
Site Reference ID/Investigator# 95588, Principal Investigator

Site Reference ID/Investigator# 112537, Hillsborough, New Jersey 08844, United States; Recruiting
Site Reference ID/Investigator# 112537, Principal Investigator

Site Reference ID/Investigator# 95594, Newark, New Jersey 07102, United States; Recruiting
Site Reference ID/Investigator# 95594, Principal Investigator

Site Reference ID/Investigator# 95582, Bronx, New York 10468, United States; Not yet recruiting
Site Reference ID/Investigator# 95582, Principal Investigator

Site Reference ID/Investigator# 95586, Chapel Hill, North Carolina 27599-7215, United States; Recruiting
Site Reference ID/Investigator# 95586, Principal Investigator

Site Reference ID/Investigator# 137077, Tulsa, Oklahoma 74104, United States; Recruiting
Site Reference ID/Investigator# 137077, Principal Investigator

Site Reference ID/Investigator# 95589, Dallas, Texas 75235, United States; Recruiting
Site Reference ID/Investigator# 95589, Principal Investigator

Site Reference ID/Investigator# 95595, Dallas, Texas 75246, United States; Recruiting
Site Reference ID/Investigator# 95595, Principal Investigator

Site Reference ID/Investigator# 95587, Houston, Texas 77004, United States; Recruiting
Site Reference ID/Investigator# 95587, Principal Investigator

Site Reference ID/Investigator# 102955, Lynchburg, Virginia 24501, United States; Recruiting
Site Reference ID/Investigator# 102955, Principal Investigator

Site Reference ID/Investigator# 95600, Seattle, Washington 98101, United States; Recruiting
Site Reference ID/Investigator# 95600, Principal Investigator

Additional Information

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

Starting date: August 2013
Last updated: July 20, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017