Clinical trial: Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects (NCT00344123)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects must have a body mass index (BMI) of 18 to 30 kg/m2, inclusive (BMI = weight
             (kg)/[height (m)]2) and weigh at least 50 kg.

          -  Males or females, ages > 18 to < 65 years.

          -  Women of childbearing potential (WOCBP) must not be nursing or pregnant. All women of
             childbearing potential (have not reached menopause nor undergone hysterectomy,
             bilateral oophorectomy, or tubal ligation) must have a negative serum human chorionic
             gonadotropin (HCG) test performed at screening (within 24 hours before the start of
             study day 1). Female subjects who are not of reproductive potential (have reached
             menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or
             whose male partner has undergone successful vasectomy with resultant azoospermia or
             has azoospermia for any other reason, are eligible without requiring the use of
             contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy,
             tubal ligation, or vasectomy) and azoospermia by patient-reported history is
             acceptable. Both male and female study volunteers of reproductive potential must agree
             not to participate in a conception process (i.e., active attempt to become pregnant or
             to impregnate via sperm donation or in vitro fertilization), and, if participating in
             sexual activity that could lead to pregnancy, the female study volunteer/male partner
             must use a form of contraception as specified below while receiving protocol-specified
             medication(s) and for one month after stopping the medication(s). Male study
             volunteers will be required to use a barrier method for at least 3 months after
             completion of the study.

               -  Condoms (male or female) with or without a spermicidal agent

               -  Diaphragm or cervical cap with spermicide

        Exclusion Criteria:

          -  History or current evidence of any significant acute or chronic medical illness that,
             within the investigator's discretion, would interfere with the conduct or
             interpretation of the study.

          -  History of acute or chronic pancreatitis.

          -  History of diabetes mellitus, hypertriglyceridemia, or chronic renal insufficiency.

          -  Proven or suspected acute hepatitis at the time of study entry.

          -  Current or recent (within 3 months) gastrointestinal disease which would interfere
             with the conduct or interpretation of the study.

          -  Any major surgery within 4 weeks of enrollment. Any gastrointestinal surgery that
             could impact upon the absorption of study drug.

          -  Donation of blood or plasma to a blood bank or in a clinical study (except a screening
             visit) within 4 weeks of enrollment.

          -  Inability to tolerate oral medication.

          -  Inability to tolerate venipuncture and/or absence of secure venous access.

          -  Known or suspected HIV infection or chronic hepatitis B virus (HBV) or hepatitis C
             virus (HCV) infection

          -  Known active drug or alcohol abuse which, in the opinion of the investigator, makes
             study participation to completion unlikely.

          -  Any other sound medical, psychiatric, and/or social reason, as determined by the
             investigator.

          -  Subjects with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
             bilirubin above the upper limit of normal.

          -  Hemoglobin < 9.5 g/dL, and platelet count < 100,000/mm3.

          -  Subjects with creatine phosphokinase (CPK) elevation greater than 3 times the upper
             limit of normal.

          -  Any other clinically significant screening lab abnormality (as determined by the
             investigator)

          -  History of any significant drug allergy, drug rash, or sensitivity to any class of
             drugs relevant to the study drugs.

          -  Prior exposure to tipranavir/ritonavir.

          -  Exposure to any investigational drug within 4 weeks of enrollment and throughout the
             study.

          -  Any previous hypersensitivity or intolerance to tipranavir or ritonavir or any other
             ingredient of Aptivus or Norvir.

          -  Hypersensitivity to sulfonamides

          -  Any previous hypersensitivity or intolerance to rosuvastatin or any other ingredient
             of Crestor (rosuvastatin).

          -  Known elevated liver enzymes in past clinical trials with any compound

          -  Use of any agent, within 2 weeks of dosing, that is known to induce or inhibit drug
             metabolizing enzymes

          -  Use of any over-the-counter drugs, including antacids, alternative herbal products, or
             prescription drugs that, in the opinion of the investigator, might interfere with the
             absorption, distribution, or metabolism of TPV, RTV, or rosuvastatin within 14 days of
             study entry.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? 0