HIV/AIDS Tuberculosis and HIV/AIDS
Conditions
Interventions
All subjects will receive 600 mg rifampicine for 15 days.
After 5 days, the subjects will be randomised into two groups
Group 1 will also take 3 tablets of Kaletra twice daily
Group 2 will also take 4 tablets of Kaletra twice daily.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameters; AUC, and more specifically, the therapeutic plasma (trough) concentratie of lopinavir in each of the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; adverse effects and biochemistry of the dose modifications of kaletra in combination with rifampicin in healthy volunteers. The effect of Kaletra on the pharmacokinetic profile (Cmax in particular) of rifampicin. | — |
Countries
Netherlands
Outcome results
None listed