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 |
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.
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
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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
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
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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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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