Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at steady state plasma concentrations on other platelet functions and biomarkers of coagulation and fibrinolysis.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Ability and willingness to give written informed consent to participate in this study (i.e., prior to any study-specific procedures)
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Age ≥18 years and ≤50 years
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Female subjects of child-bearing potential were eligible if:
- They had used a barrier contraceptive method for at least 12 weeks before administration of study medication and had a negative serum pregnancy test result during the screening period (Day - 35 to Day -3); or,
- Were abstinent for more than 12 weeks before screening and had a negative serum pregnancy test result during the screening period (Day -35 to Day -3); or,
- Had a documented tubal ligation and had a negative serum pregnancy test result during the screening period (Day -35 to Day -3)
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Ability to swallow capsules without difficulty
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Reasonable probability of completing the study
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Findings from medical history, physical examination and 12-lead ECG indicating subject was healthy and suitable for the trial in the opinion of the investigator
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Agreement to abstain from alcohol consumption or drugs of abuse during the study
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Agreement to abstain from ingestion of grapefruit, grapefruit juice, Seville oranges, or orange marmalade from screening period to the end of the study
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Negative urine drug screen for drugs of abuse
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Non smoker
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Agreement to abstain from use of tobacco products from screening period to the end of the study
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Negative HIV-1 serology by ELISA testing
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Negative Hepatitis B surface Antigen test (HBsAg)
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Negative Hepatitis C Virus antibody (anti-HCV) test by Enzyme Immunoassay
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Platelet count ≥125,000/mm3
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Hemoglobin ≥11.0 g/dL
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Prothrombin time ≤1.0 x upper limit of normal (ULN)
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Activated Partial thromboplastin time ≤1.0 x ULN
Exclusion criteria
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Female subjects who:
- had a positive serum pregnancy test during the screening period (Day -35 to Day -3) or during the study
- were breast feeding or planing to breast feed at any time from the screening period through 30 days after the last dose of the study drug
- were not willing to use a barrier method of contraception at any time from screening period through 30 days after the last dose of the study drug
- were taking any hormonal therapy for any reason such as birth control or replacement therapy
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Had used any investigational agent within 30 days prior to Visit 2
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Blood or plasma donations (>100 mL total) for research or altruistic reasons within 30 days prior to Visit 2
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Had used aspirin or any non-steroidal anti-inflammatory agent (NSAID), and including COX-2 inhibitors, dipyridamole, clopidogrel, ticlopidine or other antiplatelet drugs within 14 days prior to Visit 2 or during the study
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Active peptic ulceration or history of peptic ulcer disease
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Known history of or suspected hypersensitivity to aspirin, any NSAID or any other component of the test drugs (Tipranavir, Darunavir, Ritonavir)
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Known hypersensitivity to antiretroviral drugs (marketed or experimental drug in clinical research studies)
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Active bleeding disorder or history of active bleeding disorder
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Active Intra cranial hemorrhage (ICH) or history of ICH
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Active coronary artery disease or history of coronary artery disease
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Alcohol abuse (more than 60 g/day)
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Any indication for current use of aspirin or any NSAID or indication for such use from Visit 2 to Visit 18
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Had used any over-the-counter medication within 7 days prior to Visit 2, or current use of any prescription drug
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Subjects who had an abnormal laboratory result of Grade 1 or greater, as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS), (result must have been available at least 3 days prior to Visit 2-Day 1), except the following screening laboratory values:
- serum potassium, serum sodium, serum phosphate and uric acid, where central laboratory reference ranges will be used to determine eligibility rather than DAIDS table; or,
- amylase or creatinine results of Grade 1 on DAIDS table if these results are considered clinically not significant by investigator; or
- other marginally abnormal laboratory values not considered clinically significant by investigator and approved by clinical monitor
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History of any illness that in the opinion of the investigator might confound the results of the study or pose additional risks in administering aspirin, Tipranavir, Darunavir, or Ritonavir
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Hypersensitivity to sulphonamide drugs
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Had used proton pump inhibitors during 14 days prior to Visit 2
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Vitamin E intake in excess of 60 mg/day within 30 days prior to Visit 2
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Vitamin E supplementation in excess of 60 mg/day during the study (Vitamin E content of multivitamin tablets is allowed)
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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