HIV Infections Clinical Trial
Official title:
A Prospective Multicenter, Phase II, Open Label, Controlled Trial Evaluating the Response of Hepatitis C Virus (HCV) to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus (HIV)
Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.
Hemophiliacs with symptomatic disease often receive blood products to correct clotting
factor deficiencies. Prior to routine use of heat inactivation and screening of donor blood
for specific viral pathogens, hemophiliacs were routinely exposed to, and infected with,
viruses such as hepatitis B (HBV), HCV, and HIV. Studies in hemophiliacs suggest several
important findings that warrant further investigation, including: 1) hemophiliacs infected
with HCV may have more rapid progression to liver failure and death; 2) pooled blood
concentrate from multiple donors leads to a high risk of mixed infection; and 3) different
clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance
understanding of mutant virus selection and the associated clinical outcomes. The purpose of
this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs
with HCV alone and with HCV/HIV coinfection.
Participants in this study will be followed for 48 weeks on treatment and up to 36 months
after treatment. Participants in this study will be admitted to the Clinical Research Center
for 2 days at the beginning of the study. Participants will have 3 additional study visits
in the first week of the study. After that, study visits occur at Weeks 2, 4, 8, 12, 16, 24,
32, 40, and 48. The follow-up visits will be at 4, 12, and 24 weeks following the end of
treatment. Study visits include a physical exam and blood tests. Patients who do not respond
to treatment will be followed in a prospective cohort study for up to 3 additional years so
that evolution of the virus and associated immune responses can be evaluated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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