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
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials