A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Background:
- Chronic hepatitis C (CHC) is a major health problem that particularly affects
individuals with human immunodeficiency virus (HIV) infection, and can lead to cirrhosis
and liver failure. Standard treatment for people with HIV and CHC is a 48-week course of
pegylated-interferon alfa 2a (peg-IFN) and ribavirin (RBV), but better treatments are
needed for those who either do not respond to the drugs or who relapse after treatment.
- Nitazoxanide has been approved by the Food and Drug Administration primarily to treat
diarrhea caused by parasites, and it has been studied in the treatment of CHC infection.
However, it has not been tested in persons infected with HIV and CHC co-infection.
Researchers are interested in determining whether nitazoxanide is a safe and tolerable
treatment for CHC in individuals with HIV.
Objectives:
- To assess the safety and tolerability of using nitazoxanide to treat chronic hepatitis C
infection in individuals with HIV who have not responded to standard treatment for hepatitis
C.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with both HIV and chronic
hepatitis C, and who have either not responded to or relapsed after previous hepatitis C
treatment.
Design:
- Participants will be screened with a physical examination and medical history; blood and
urine tests; imaging studies; possible heart, lung, and psychological tests; and a liver
biopsy if one has not been done in the past 3 years.
- Participants will receive nitazoxanide, the medication being studied, to take by mouth
for 4 weeks, and will provide blood samples during this time.
- After 4 weeks, participants will receive the first dose of peg-IFN and RBV. Participants
will have weekly injections of peg-IFN and continue to take nitazoxanide and RBV by
mouth for 48 weeks. Individuals who are slow to respond to this combined CHC treatment
(nitazoxanide, peg-IFN, and RBV) by week 12 will continue to have the combined treatment
for an extended period, a total of 72 weeks.
- Participants will have study visits to provide blood samples and have other tests two
times in the first month of combined treatment, and then at months 2, 3, 4, 7, 10, 13,
19; and month 25 only in participants slow to respond to combined treatment.
- Some participants who are on specific HIV treatment regimens may enroll in a substudy
that will require three separate 12-hour visits for repeated blood samples and other
tests during the initial 4-week nitazoxanide treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)