Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Stopped early · Phase 3

Conditions studied: Chronic Hepatitis C Infection

In brief

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Key facts

Study ID

NCT01866930

Run by

Bristol-Myers Squibb

People needed

453

Starts

2013-07-11

Expected to finish

2015-08-27

Last updated by the study team

2023-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV Genotype-1, -2, -3 or -4 treatment naïve;
• HCV RNA ≥10,000 IU/mL at screening;
• HIV-1 infection [(approximately 200 subjects receiving HAART, approximately 100 subjects not receiving highly active antiretroviral therapy (HAART)];
• For subjects receiving HAART, HIV RNA must be below <40 copies/mL at screening and <200 copies/mL for at least 8 weeks prior to screening;
• CD4 cell count at screening must be ≥100 cells/μL if receiving HAART or ≥350 cells/μL if not receiving HAART)
• Seronegative for Hepatitis B Surface Antigen (HBsAg)
• Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI=weight (kg)/[height (m)]2 at screening;
• Subjects with compensated cirrhosis are permitted, but the number of subjects will be capped at approximately 30%. If a subject does not have cirrhosis, a liver biopsy within 3 years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. Fibroscan® or FibroTest are acceptable if performed within 1 year prior to treatment in countries where liver biopsy is not required prior to treatment and where non-invasive imaging tests are approved for staging of liver disease
• Subjects with mild to moderate hemophilia as defined as:
• Mild-factor level activity of 6-4% OR
• Moderate defined as factor level activity of 1-5%

You may not qualify if…

• Any evidence of liver disease other than chronic HCV;
• Subjects infected with human immunodeficiency virus (HIV-2);
• Diagnosed or suspected hepatocellular carcinoma;
• Decompensated liver disease;
• Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC, (CDC, JAMA 1993 Feb 10;269(6):729-30)
• Laboratory values: ANC <1.5 x 109 cells/L (<1.2 x 109 cells/L for Blacks), platelet count <90 x 109 cells/L, hemoglobin <11 g/dL for females, hemoglobin <12 g/dL for males;
• Subjects (receiving HAART) who had first initiated anti-retroviral therapy within last 8 weeks prior to Day 1; however, if changes are required to a subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subjects should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/mL
• Subjects on Zidovudine (AZT), Didanosine (ddI), or Stavudine (d4T);
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Subjects with severe hemophilia (defined as <1% factor activity level)

Where it is running

• University Of California San Francisco — San Francisco, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• University Of Colorado Denver & Hospital — Aurora, Colorado, United States
• University Of Colorado Denver — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Orlando Va Medical Center — Orlando, Florida, United States
• Emory Hospital Midtown Infectious Disease Clinic — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Ut Southwestern Medical Center — Dallas, Texas, United States
• Local Institution — Buenos Aires, Bs As, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Quilmes, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Argentina
• Local Institution — Buenos Aires, Argentina
• Local Institution — Antwerp, Belgium
• Local Institution — Brussels, Belgium
• Local Institution — Brussels, Belgium
• University Of Alberta Hospitals — Edmonton, Alberta, Canada
• St Pauls Hospital — Vancouver, British Columbia, Canada
• Vancouver Id Reserach & Care Centre Society — Vancouver, British Columbia, Canada
• Hamilton Health Sciences, Mcmaster Site — Hamilton, Ontario, Canada
• Inland Empire Liver Foundation — Rialto, California, United States

Full record on ClinicalTrials.gov

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