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

Phase 2

Completed

• Conditions: HIV; human immunodeficiency virus; 10047438

• Registration Number: NL-OMON33412
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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.

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 (see Appendix A for normal ranges of clinical laboratory values).
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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>comparison of raltegravir pharmacokinetics (AUC, Cmax and Cmin) after 2 weeks<br /><br>of 400mg BID dosing versus 2 weeks of 800mg QD dosing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>viral load (efficacy), adverse events (safety).</p><br>