Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and H… (NCT00991289) | Clinical Trial Compass
CompletedPhase 2
Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects
United States68 participantsStarted 2010-01
Plain-language summary
Infection with hepatitis C virus (HCV) can cause liver scarring, or cirrhosis, and this usually occurs more rapidly among people infected with both HCV and human immunodeficiency virus (HIV). People infected with both HCV and HIV have poor response to the current HCV treatments. This phase II pilot study evaluated whether adding a new HCV medication improves response to the current standard HCV treatment with pegylated interferon and ribavirin in people with both HCV and HIV.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* HIV-1 infection
* Documentation of hepatitis C virus (HCV) genotype 1 infection prior to entry
* Chronic HCV infection for at least 180 days
* CD4+ cell count greater than 200 cells/mm3 obtained within 90 days prior to study entry
* Detectable HCV viral load obtained within 90 days prior to study entry
* Any change in antiretroviral (ARV) regimen, including initiation of antiretroviral therapy (ART), a switch in ART regimen, or a discontinuation of ART, had to have occurred more than 60 days prior to study entry. Breaks in therapy for a maximum of 14 days total during the 60-day period were allowed. Participants not on ART should have had no plans to initiate therapy during the first 24 weeks after study entry. Participants who did start ART did not have to discontinue study treatment. Participants on ART should have planned to remain on the same therapy for at least 12 weeks after study entry. Changes in formulation or dosage were permitted.
* Certain laboratory values obtained within 42 days prior to study entry
* Agreement to use contraception, if participating in sexual activity that could lead to pregnancy, for the duration of study and for 6 months afterward
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase less than or equal to five times the upper limit of normal (ULN)
* Hemoglobin \>=11 g/dl for men and \>=10 g/dl for women
Exclusion Criteria:
* Use of the ARV didanosine (ddI)
* Receipt of any interf…
What they're measuring
1
Percentage of Participants With Complete Early Virologic Response (cEVR)
Timeframe: Week 16
2
Percentage of Participants With Early Virologic Response (EVR)
Timeframe: Weeks 0, 16
Trial details
NCT IDNCT00991289
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)