Dose modifications of the new Kaletra Meltrex tablets when combined with rifampin in healthy volunteers (DAKTARI)
- Conditions
- HIV/AIDSTuberculosis and HIV/AIDS10028440
- Registration Number
- NL-OMON29988
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
1. Subject is at least 18 and not older than 55 years of age on the day of the first dosing.
2. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
3. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
5. Subject is in a good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose.Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges of the National Cancer Institute (see http://ctep.cancer.gov/forms/CTCv20_4-30-992.pdf ). If not, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
6. Female subject is either not of childbearing potential, defined as postmeno-pausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD); has a vasectomized partner; or total abstinence from sexual intercourse
7. Subject has a normal blood pressure and pulse rate, according to the Investiga-tor's judgement.
1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
2. Positive HIV test.
3. Positive hepatitis B or C test.
4. Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
5. Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal dis-orders (especially diabetes mellitus), coagulation disorders.
6. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
7. History of or current abuse of drugs, alcohol or solvents.
8. Inability to understand the nature and extent of the trial and the procedures required.
9. Participation in a drug trial within 60 days prior to the first dose.10. Donation of blood or plasma pheresis within 60 days prior to the first dose.
11. Mantoux test > 15 mm, or >0-15 mm with chest X-ray positive for tuberculosis
12. Use of contact lenses
13. Febrile illness within 3 days before the first dose
14. Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The pharmacokinetic parameters; AUC, and more specifically, the therapeutic<br /><br>plasma (trough) concentratie of lopinavir in each of the groups.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety; adverse effects and biochemistry of the dose modifications of kaletra<br /><br>in combination with rifampicin in healthy volunteers.<br /><br><br /><br>The effect of Kaletra on the pharmacokinetic profile (Cmax in particular) of<br /><br>rifampicin. </p><br>