Pharmacokinetic and safety pilotstudy of RAltegravir and atazanavir in a once DAily dose regimen in HIV-1 in-fected patients (PRADA) - PRADA

Conditions: MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection
HIV infected patients

Registration Number: EUCTR2008-008556-16-DE

Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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 screening.
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
4. HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy.
5. Subject has no history of previous virological failure or documented resistance mutations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 > 5 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, Ginkgo Biloba, didanosine, tenofovir, efavirenz, nevirapine, antacids, clarithromycin, phenytoin, phenobarbital, carbamazepine.
7. Active hepatobiliary or hepatic disease (including chronic hepatitis B infection).
8. Alcohol abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>To determine the safety of combined use of raltegravir and atazanavir QD in HIV- infected patients <br>;Primary end point(s): The comparison of raltegravir pharmacokinetics (AUC, Cmax, Cmin) after 2 weeks of 400mg BID dosing versus 2 weeks of 800mg QD dosing

Secondary Outcome Measures