A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)



Status:Recruiting
Conditions:HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2012
Contact:Central Contact Center
Email:medicalinfo@vrtx.com

Use our guide to learn which trials are right for you!

An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)


The purpose of this study is to treat HIV and HCV coinfected subjects with telaprevir,
peg-interferon alfa-2a, and ribavirin to achieve undetectable HCV RNA 12 weeks after the
last planned dose of study drug.


Inclusion Criteria:

- Subjects must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA >1000 IU/mL

- Population A: HCV Peg IFN/RBV treatment naive (received no prior HCV therapy)or
Peg-IFN/RBV prior treatment with relapse

- Population B: Peg-INF/RBV prior null or partial responder

- Subjects must not have achieved SVR24 after at least 1 prior course of Peg IFN/RBV
therapy of standard duration

- Subject must have positive HIV antibody at Screening

- Subject must have a diagnosis of HIV-1 infection >6 months before Screening

- Subjects should be taking 1 of the following permissible HAART regimens for HIV
continuously for 12 weeks prior to screening:

- Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)

- Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components

- Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir,
emtricitabine) or equivalent components

- Boosted atazanavir plus Epzicom®, or equivalent components

- Raltegravir plus Truvada®, or equivalent components

- Raltegravir plus Epzicom®, or equivalent components

- CD4 counts and HIV-1 RNA meeting acceptable criteria at Screening as specified in the
protocol.

- Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

- Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or
any switches occurring 12 weeks prior to Day 1

- Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides

- Contraindications to any planned HAART component as per the respective drug labeling
information

- Contraindications to Peg IFN or RBV

- Evidence of hepatic decompensation

- Clinical suspicion of acute hepatitis

- Any other cause of liver disease in addition to hepatitis C

- History of organ transplantation (except cornea and skin)

- Autoimmune-mediated disease

- Participated in any investigational drug study within 90 days before Day 1

- Previous treatment with an HCV protease inhibitor
We found this trial at
27
sites
Birmingham, Alabama
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
, Georgia
?
mi
from
, GA
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Chicago, Illinois
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbia, South Carolina
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Coronado, California
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Fairfax, Virginia
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Gainesville, Florida
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas
?
mi
from
Houston, TX
Click here to add this to my saved trials
Manhasset, New York
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Haven, Connecticut
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Newark, New Jersey
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Novi, Michigan
?
mi
from
Novi, MI
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Portland, Maine
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island
?
mi
from
Providence, RI
Click here to add this to my saved trials
Salt Lake City, Utah
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Seattle, Washington
?
mi
from
Seattle, WA
Click here to add this to my saved trials
St Louis, Missouri
?
mi
from
St Louis, MO
Click here to add this to my saved trials
Washington, District of Columbia
?
mi
from
Washington,
Click here to add this to my saved trials
DC
Washington DC, District of Columbia
?
mi
from
Washington DC,
Click here to add this to my saved trials