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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| University of Colorado, Denver | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribavirin plus Abacavir | Active Comparator | Ribavirin plus Abacavir Administration intervention |
|
| Ribavirin alone | Active Comparator | Ribavirin alone administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations | Ribavirin Triphosphate (RBV-TP) intracellular concentrations. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma RBV Trough Concentrations | Plasma RBV trough concentrations. | Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana Andrade, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Drug Development Unit | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26869690 | Derived | 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. |
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Subjects were recruited through general newspaper advertisements, flyers, and referral from providers specializing in hepatitis C
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| ID | Title | Description |
|---|---|---|
| FG000 | Ribavirin Plus Abacavir | Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: Daily Ribavirin 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 600 mg orally every 12 hours (Body Weight >75 kg) plus Daily Abacavir 300 mg orally every 12 hours |
| FG001 | Ribavirin Alone | Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ribavirin Plus Abacavir | Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations | Ribavirin Triphosphate (RBV-TP) intracellular concentrations. | Posted | Mean | Standard Deviation | picomoles per 10^6 cells | Day 56 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ribavirin Plus Abacavir | Ribavirin plus Abacavir Administration intervention Ribavirin plus Abacavir: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperbilirubinemia | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Drug Development Unit | Johns Hopkins School of Medicine | (410) 614-8762 | ejfuchs@jhmi.edu |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C106538 | abacavir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin plus Abacavir (ABC) | Drug | 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 |
|
|
| Ribavirin Alone |
Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Plasma RBV Trough Concentrations | Plasma RBV trough concentrations. | Posted | Mean | Standard Deviation | micrograms per milliliter | Day 56 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 10 |
| 14 |
| EG001 | Ribavirin Alone | Ribavirin alone administration Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in 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) | 0 | 12 | 0 | 12 | 11 | 12 |
| fatigue | General disorders | Non-systematic Assessment |
|
| hyperglycemia | Endocrine disorders | Non-systematic Assessment |
|
| insomnia | General disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| transaminitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |