CompletedPhase 1/2

A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures

United States8 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* ELIGIBILITY CRITERIA: To be eligible for participation on this protocol, a participant must satisfy all of the following conditions: Be greater than or equal to 18 years old and have an identifiable Primary Care Provider. Have either documentation of HIV-1 infection by licensed enzyme-linked immunosorbent assay (ELISA) and confirmed by a Western Blot or HIV RNA of 1,000 copies/mLor greater. Have documentation of chronic HCV (CHC) infection by demonstration of a positive test for hepatitis C antibocy and HCV RNA of 2,000 IU/mL or greater Have histopathologic features consisten with CHC at the time of enrollment. A liver biopsy done for a participant with 36 months prior to his or her participant may be used as the baseline biopsy. Participants can opt out of a biopsy if they had one or more than 36 months prior and have a contraindication, sucha as receiving chronic anticoagulation therapy. Participants with decompensated liver disease are excluded from study. Are co-infected infected with HCV genotype 1 and HIV viruses. 1. Relapsers: Participants who had an undetectable HCV RNA (\< 10 IU/mL) at the end of prior treatment (ETR) but have detectable HCV RNA by Week 72 or thereafter. 2. Non-responders: Participants who have received at least 12 weeks of treatment with any IFN alfa 2a or 2b with ribavirin and have not achieved either a 2 log (10) drop in HCV viral levels at week 12 (null responder) nor has not achieved a HCV RNA below the level of detection by Week 24 (\<…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events

Timeframe: 1 year and 2 months

Trial details

NCT IDNCT01185028

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-03-21

View on ClinicalTrials.gov More Hepatitis C Infection trials