HIV infected patients MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Isentress
Product Name: raltegravir
Pharmaceutical Form: Tablet
INN or Proposed INN: raltegravir
CAS Number: 871038-72-1
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot. 2. Subject is at least 18 years of age at the day of the first dosing. 3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 4. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes in-cluded. 5. HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial. 2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 3. Inability to understand the nature and extent of the trial and the procedures re-quired. 4. Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female. 5. Abnormal serum transminases determined as levels being > 3 times upper limit of normal. 6. Concomitant use of medications that interfere with raltegravir or atazanavir pharmacokinetics: rifampicin, irinotecan, midazolam, triazolam, ergotamine, dihydroergotamine, cisapride, pimozide, lovastain, simvastatin, indinavir, proton pump inhibitors, H2 receptor antagonists, St. john’s wort, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine. 7. Active hepatobiliary or hepatic disease. 8. Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. raltegravir 800 mg once daily (QD) by intrasubject comparison;Secondary Objective: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD, atazanavir 600mg QD and lamivudine 300mg or emtricitabine 200mg QD in HIV-infected patients To determine the safety of combined use of raltegravir and atazanavir QD in HIV- infected patients ;Primary end point(s): The comparison of raltegravir pharmacokinetics (AUC, Cmax, Cmin) after 4 weeks of 400mg BID dosing versus 4 weeks of 800mg QD dosing | — |
Countries
Germany, Netherlands
Outcome results
None listed