A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:January 2015

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A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)

A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the
treatment of hepatitis C virus and HIV coinfection.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Key Inclusion Criteria:

- Patients must be able to understand and agree to/comply with the prescribed dosing
regimens and procedures, report for regularly scheduled study visits, and reliably
communicate with study personnel about adverse events and concomitant medications

- Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or
6, as documented by positive HCV RNA at screening

- Patients who are HCV treatment-naive

- Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies
discontinued or completed at least 12 weeks prior to screening

- Patients with HCV RNA ≥10,000 IU/mL at screening

- Patients with HIV-1 infection

Key Exclusion Criteria:

- Presence of AIDs-defining opportunistic infections, as defined by the Centers of
Disease Control and Prevention, within 12 weeks prior to study entry

- Patients infected with HIV-2

- Liver or any other organ transplant (including hematopoietic stem cell transplants)
other than cornea and hair

- Current or known history of cancer (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to screening

- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained
imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this
was performed

- Evidence of decompensated liver disease, including radiologic criteria, a history or
presence of ascites, bleeding varices, or hepatic encephalopathy
We found this trial at
37
sites
Providence, Rhode Island 02905
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Allentown, Pennsylvania 18105
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Aurora, Colorado 80045
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Baltimore, Maryland 21229
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Beverly Hills, California 90211
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Binghamton, New York 13903
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Decatur, Georgia 30033
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Detroit, Michigan 48202
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Fort Pierce, Florida 34982
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Fort Worth, Texas 76104
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Houston, Texas 77004
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Long Beach, California 90822
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Los Angeles, California 90069
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Los Angeles, California 90036
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Los Angeles, California 90028
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1101 East 33rd Street
Lutherville, Maryland 21093
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Miami, FL
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Murray, UT
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Richmond, Virginia 23249
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92103
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San Diego, California 92115
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San Francisco, California 94143
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Sante Fe, New Mexico 87505
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Tulsa, Oklahoma 74135
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Washington, District of Columbia 20009
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Washington, District of Columbia 20036
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Washington, District of Columbia
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