Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV (NCT01443923) | Clinical Trial Compass
TerminatedPhase 4
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
Stopped: Unable to complete enrollment due to newly approved treatment options.
United States4 participantsStarted 2011-09
Plain-language summary
Background:
\- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV.
Objectives:
\- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections.
Eligibility:
* Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV
* Half of the study participants will also have HIV infection.
Design:
* Participants will be screened with a medical history and physical exam. They will also have blood and urine tests.
* Participants will also have heart and liver function tests, and answer questions about mood and depression.
* Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly.
* Two weeks after starting treatment, participants will have blood tests to study the treatment.
* Four weeks after starting treatment, participants will start taking boceprevir three times a day.
* Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.
Who can participate
Age range
18 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.
Inclusion criteria
. Be greater than or equal to18 years old and have an identifiable primary care provider.
. Have documented chronic HCV infection by demonstration of a positive test for hepatitis C antibody and HCV RNA of 2,000 IU/mL or greater.
. Infected with HCV GT-1 virus.
. If coinfected, have either documentation of HIV-1 infection by licensed enzyme-linked immunosorbent assay (ELISA) confirmed by a Western Blot or history of HIV RNA of 1,000 copies/mL or greater.
. If coinfected, must meet one of the following prior to enrollment:
. If on a stable non-NNRTI or non-PI antiretroviral regimen that HAS NOT changed within the past 6 months, must have an HIV-1 VL of less than 400 copies/mL for at least 3 months; or
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
1
Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.
Timeframe: 6 months post treatment
Trial details
NCT IDNCT01443923
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. If on a current antiretroviral regimen that HAS changed within the past 6 months, have an HIV-1 VL of less than 50 copies/mL for at least 3 months; or
. Be a long-term nonprogressor as documented in the medica record.
Exclusion criteria
. Use of other experimental therapies (including expanded access/compassionate use of HIV antiretrovirals) within 30 days or 5 half-lives (whichever is longer), prior to enrollment.
. Current use of an efavirenz-based (or other NNRTI) or protease inhibitor HIV antiretroviral regimen.
. Use of any of the following medications within 6 weeks prior to enrollment.
--Use of any use of any immunosuppressive therapy, including systemic steroids (prednisone equivalent of greater than 10 mg/day) for a duration of 6 weeks or more within 6 months prior to enrollment. Use of inhaled/nasal steroids should be avoided.
. Has ingested silymarin (milk thistle), s-adenosylmethionine (SAM-e), glycyrrhizin, Sho-saiko-to (SST), or other herbal supplements that may be either liver beneficial or toxic, within 28 days prior to enrollment.
. Mixed HCV genotypes (e.g., 1 \& 2, 1 \& 3, 1 \& 4) (mixed genotype 1a/1b can be included).
. Has any other known, or clinically suspected, cause of liver disease, including active hepatitis B.
. For participants with cirrhosis, a Child Turcotte Pugh score greater than 7, or Child s B or C cirrhosis.