Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
Stopped early · Phase 4
Conditions studied: Hepatitis, HIV/AIDS
In brief
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.
Key facts
- Study ID
- NCT01443923
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 4
- Starts
- 2011-09-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2015-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A participant will be ineligible to participate on this study if any of the following criteria are met:
- 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.
- Alfuzosin (Uroxatral )
- Alprazolam (Xanax )
- Atorvastatin (Lipitor )
- AZT or zidovudine (Retrovir )
- Carbamazepine (Tegretol )
- Cisapride (Propulsid )
- Colchicine (Colcrys ) - If patient has renal or hepatic impairment.
- DDI or didanosine (Videx )
- d4T or stavudine (Zerit )
- Delaviridine (Rescriptor )
- Digoxin (Lanoxin )
- Dihydroergotamine
- Drosperinone (Yaz )
- Efavirenz (Sustiva )
- Ergonovine (Ergotrate )
- Ergotamine (Cafergot )
- Etravirine (Intelence )
- Ganciclovir (Cytovene )
- Immunosuppressive therapy (including oral steroids)
- --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.
- Isoniazid or INH (Ingredient in Rifater )
Where it is running
- Unity Health Care, Inc./DC General — Washington D.C., District of Columbia, United States
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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