Hepatitis CPhase 1NCT01052701
Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment
A Phase 1 study testing Ribavirin and Ribavirin plus Abacavir (ABC) in people with Hepatitis C and HIV, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis C, HIV
- What is being tested?
- Ribavirin and Ribavirin plus Abacavir (ABC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hepatitis C Virus (HCV) -monoinfected subjects who either successfully completed (defined as cured) or previously failed RBV-based therapy for hepatitis C infection, and are currently not receiving therapy for hepatitis C; at least 18-64 years of age. HCV cure is defined as a sustained undetectable viral response at 24 weeks post treatment.
- Females who are not of reproductive potential (defined as women who have been postmenopausal for at least 24 consecutive months or who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Negative serum β- human chorionic gonadotropin (HCG)
- Negative HIV-1 serology documented by any licensed Enzyme-linked immunoassay (ELISA) test kit within 30 days prior to study entry.
- Positive HCV antibody documented within 30 days prior to study entry.
- Negative Human Leukocyte Antigen (HLA)-B*5701 test documented within 30 days prior to study entry.
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- Ability and willingness of subject to provide a signed informed consent and comply with study requirements.
- All subjects must not participate in a conception process (e.g., active attempt to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, male subjects must take every precaution to avoid risk of pregnancy for their female partners by using reliable contraception (condom) while receiving study therapy and for 6 months following permanent discontinuation of study therapy. Subjects will also be instructed to counsel their female partners regarding fetal risk and need for appropriate contraception (e.g., hormonal, barrier) so as a secondary effort to prevent pregnancy even though the female partners will not be study participants.
- Estimated creatinine clearance ≥50 mL/minute, within 30 days prior to study entry
- Laboratory values obtained within 30 days prior to study entry:
- Hgb within the normal limits as defined by the reporting laboratory
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase >5 x upper limit of normal (ULN) as defined by the reporting laboratory.
- Direct bilirubin ≤1.5 x ULN as defined by the reporting laboratory.
- Follicle Stimulate Hormone (FSH) measurement elevated into the menopausal range for females who report being postmenopausal for at least 24 consecutive months is required at screening for all female subjects.
- Subject has not consumed alcohol in the 48 hours prior to the administration of study drugs.
- Framingham cardiovascular disease risk score <10%.
Who cannot join
- As determined by the investigator, a significant active or previous history of cardiovascular, renal, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease (s). This inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal condition that may affect drug absorption. History of chronic or acute medical condition that in the opinion of the investigator would jeopardize safety of subjects participating in this study. Any other medical or psychological condition that might, in the opinion of the site investigator, interfere with participation in the study or put subjects at undue risk.
- History of anemia, hemoglobinopathy or any other cause of or tendency to hemolysis.
- History of RBV-induced anemia that required dose reduction or discontinuation of RBV therapy while receiving treatment for hepatitis C infection in the past. Patients who required treatment with erythropoietin or blood transfusion for the management of RBV-associated anemia will be excluded from participating in the study.
- Use of prescription or over-the-counter medications, including herbal products, within 30 days prior to study entry that in the opinion of the investigator would preclude study participation.
- Pregnant women or men with a pregnant female partner.
- Breast feeding
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- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements, and/or currently receiving methadone replacement therapy for the treatment of substance abuse.
- Inability of abstaining from alcohol-containing beverages for the duration of the study.
- Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator.
- Known or suspected hypersensitivity reaction to study drugs or their formulations.
- Participation in any investigational drug study within 30 days prior to study entry.
- Active or history of gout disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Drug Development Unit
Baltimore, Maryland, 21287
About this study
Official title: Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment
This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.
Read the detailed description
Abacavir is an anti-HIV drug that belongs to the class of nucleoside reverse transcriptase inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and ribavirin used in this study are also FDA approved.Some individuals who have HIV infection also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level of ribavirin in the body, in the blood and in cells named peripheral blood mononuclear cells (PBMC's). Thus, taking ribavirin and abacavir together could lead to treatment failure for hepatitis C. Therefore, it is important to understand whether ribavirin levels are affected when the two medications are taken together.
- Conditions
- Hepatitis C, HIV
- Being tested
- Ribavirin, Ribavirin plus Abacavir (ABC)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Also called Ribavirin (RBV)
Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)
Ribavirin plus Abacavir (ABC)Drug
Also called RBV + ABC
Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)
OR
Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)
Plus
Daily Abacavir 300 mg orally every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin plus Abacavir | Active comparator | Ribavirin plus Abacavir Administration intervention Receives: Drug: Ribavirin plus Abacavir (ABC) |
| Ribavirin alone | Active comparator | Ribavirin alone administration Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations
Ribavirin Triphosphate (RBV-TP) intracellular concentrations.
Measured: Day 56
Secondary outcomes (1)
Plasma RBV Trough Concentrations
Plasma RBV trough concentrations.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Adriana Andrade, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052701
- Sponsor's protocol ID
- NA_00023807
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2010
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fuchs EJ, Kiser JJ, Hendrix CW, Sulkowski M, Radebaugh C, Bushman L, Ray ML, Andrade A. Plasma and intracellular ribavirin concentrations are not significantly altered by abacavir in hepatitis C virus-infected patients. J Antimicrob Chemother. 2016 Jun;71(6):1597-600. doi: 10.1093/jac/dkw009. Epub 2016 Feb 10.
PubMed 26869690
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment
- ClinicalTrials.gov ID
- NCT01052701
- Acronym / sponsor ID
- NA_00023807
- Conditions
- Hepatitis C, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University of Colorado, Denver
- Study start
- Dec 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Posted 27 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.
Detailed description
Abacavir is an anti-HIV drug that belongs to the class of nucleoside reverse transcriptase inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and ribavirin used in this study are also FDA approved.Some individuals who have HIV infection also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level of ribavirin in the body, in the blood and in cells named peripheral blood mononuclear cells (PBMC's). Thus, taking ribavirin and abacavir together could lead to treatment failure for hepatitis C. Therefore, it is important to understand whether ribavirin levels are affected when the two medications are taken together.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribavirin plus Abacavir | Active comparator | Drug: Ribavirin plus Abacavir (ABC)Ribavirin plus Abacavir Administration intervention |
| Ribavirin alone | Active comparator | Drug: RibavirinRibavirin alone administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Hepatitis C Virus (HCV) -monoinfected subjects who either successfully completed (defined as cured) or previously failed RBV-based therapy for hepatitis C infection, and are currently not receiving therapy for hepatitis C; at least 18-64 years of age. HCV cure is defined as a sustained undetectable viral response at 24 weeks post treatment.
- Females who are not of reproductive potential (defined as women who have been postmenopausal for at least 24 consecutive months or who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Negative serum β- human chorionic gonadotropin (HCG)
- Negative HIV-1 serology documented by any licensed Enzyme-linked immunoassay (ELISA) test kit within 30 days prior to study entry.
- Positive HCV antibody documented within 30 days prior to study entry.
Key exclusion criteria (12 listed)
- As determined by the investigator, a significant active or previous history of cardiovascular, renal, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease (s). This inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal condition that may affect drug absorption. History of chronic or acute medical condition that in the opinion of the investigator would jeopardize safety of subjects participating in this study. Any other medical or psychological condition that might, in the opinion of the site investigator, interfere with participation in the study or put subjects at undue risk.
- History of anemia, hemoglobinopathy or any other cause of or tendency to hemolysis.
- History of RBV-induced anemia that required dose reduction or discontinuation of RBV therapy while receiving treatment for hepatitis C infection in the past. Patients who required treatment with erythropoietin or blood transfusion for the management of RBV-associated anemia will be excluded from participating in the study.
- Use of prescription or over-the-counter medications, including herbal products, within 30 days prior to study entry that in the opinion of the investigator would preclude study participation.
- Pregnant women or men with a pregnant female partner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinAlso: Ribavirin (RBV)Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg) | Drug | Ribavirin alone |
| Ribavirin plus Abacavir (ABC)Also: RBV + ABCDaily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg) Plus Daily Abacavir 300 mg orally every 12 hours | Drug | Ribavirin plus Abacavir |
Primary outcome
Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations
Time frame: Day 56
Ribavirin Triphosphate (RBV-TP) intracellular concentrations.
1 secondary outcome
Plasma RBV Trough Concentrations
Time frame: Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26869690Fuchs EJ, Kiser JJ, Hendrix CW, Sulkowski M, Radebaugh C, Bushman L, Ray ML, Andrade A. Plasma and intracellular ribavirin concentrations are not significantly altered by abacavir in hepatitis C virus-infected patients. J Antimicrob Chemother. 2016 Jun;71(6):1597-600. doi: 10.1093/jac/dkw009. Epub 2016 Feb 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Andrade, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ribavirin and Ribavirin plus Abacavir (ABC) in people with Hepatitis C and HIV, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.