HIV infectie HIV and Fungal infection
Conditions
Interventions
During this study, which lasts 31 days in total, subjects have to take study
medication during three treatment-periods which last from 3, 10 and 10 days
each.
There will be 24 participants
There is
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) The signed informed consent form. 2) Target Population a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. b) Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2. 3) Age and Sex a) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 inclusive. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Post menopause is defined as: • Amenorrhea >= 12 consecutive months without another cause or • For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Exclusion criteria
Exclusion criteria: 1) Sex and Reproductive Status a) WOCBP • WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. b) Women who are pregnant or breastfeeding c) Women with a positive pregnancy test on enrollment or prior to administration of investigational product. d) Sexually active fertile men not using effective birth control if their partners are WOCBP. 2) Medical History and Concurrent Diseases a) Proven or suspected acute hepatitis (within 12 months prior to the 1st dose) b) Any significant acute or chronic medical illness. c) Current or recent (within 3 months) gastrointestinal disease. d) Any major surgery within 4 weeks prior to study drug administration. e) Any gastrointestinal surgery that could impact upon the absorption of study drug. f) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration. g) Blood transfusion within 4 weeks prior to study drug administration. h) Inability to tolerate oral medication. i) Inability to be venipunctured and/or tolerate venous access. j) Smoking more than 5 cigarettes per day. k) Recent (within 6 months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse (Appendix 2). l) Any other sound medical, psychiatric and/or social reason as determined by the investigator. m) Consumption of alcohol within 3 days prior to the first dose of study drug. n) Intractable diarrhea (>= 6 loose stools/day for at least 7 consecutive days) within 30 days prior to the first dose of study drug. o) History of any hemolytic disorders (including drug-induced hemolysis). p) History of acute or chronic pancreatitis. q) History of hypochlorhydria or achlorhydria. 3) Physical and Laboratory Test Findings a) Men and Women = 500 msec, QTcF interval >= 450 msec either at screening or prior to dosing (confirmed by repeat ECG). h) PR interval >= 210 msec, QRS interval >= 120 msec either at screening or prior to dosing (confirmed by repeat ECG). i) First, second- or third-degree A-V block or clinically relevant ECG abnormalities either at screening or prior to dosing. 4) Allergies and Adverse Drug Rea
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Safety Outcome Measures: Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance. | — |
Primary
| Measure | Time frame |
|---|---|
| • Pharmacokinetic Measures: Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC(TAU), and Ctrough) will be derived from plasma concentration versus time for ATV, RTV and VOR and the combined use of these drugs. | — |
Countries
Netherlands
Outcome results
None listed