Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|ClinicalTrials.gov Identifier: NCT01443923|
Recruitment Status : Terminated (Unable to complete enrollment due to newly approved treatment options.)
First Posted : September 30, 2011
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis HIV/AIDS||Drug: Boceprevir Drug: Peg-Interferon-alfa 2B Drug: Ribavirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, On-Treatment Trial to Assess the Effect of HIV-1 Coinfection on Therapeutic Responses Using Boceprevir, Peg-Interferon-alfa-2b and Ribavirin in HCV Genotype 1, IFN Treatment-Naive Subjects With or Without HIV-1|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Active Comparator: 1-HCV
Hepatitis C Mono-infected
Drug: Peg-Interferon-alfa 2B
Active Comparator: 2 HCV/HIV
Hepatitis C and HIV co-Infected
Drug: Peg-Interferon-alfa 2B
- Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment. [ Time Frame: 6 months post treatment ]
- Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects [ Time Frame: Day 0, Day 7 ]
- Safety and Treatment Outcome Measures Stratified by ESA Use [ Time Frame: 6 months ]
- Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment [ Time Frame: End of Treatment ]
- Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects [ Time Frame: 6 months post treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443923
|United States, District of Columbia|
|Unity Health Care, Inc./DC General|
|Washington, DC, District of Columbia, United States, 20002|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Shyamasundaran Kottilil, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|