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| Sponsor: | Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00943540 |
Purpose
The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is metabolized predominantly through glucuronidation by UGT1A1. Atazanavir increases the plasma concentrations of raltegravir 400 mg twice daily by 72% due to inhibition of UGT 1A1.
This suggests that combined use of atazanavir and a lower dose frequency of raltegravir, once daily for example, is possible. Another reason why raltegravir most likely can be applied is that its pharmacodynamic effect is not related to Cmin but to AUC which is expected to be similar for an 800mg QD dose when compared to 400mg BD. Phase III clinical trials evaluating QD dosing of raltegravir are currently ongoing and interim results are expected to be published in mid 2009.
A regimen of atazanavir and raltegravir in combination with lamivudine or emtricitabine may be a well tolerated and effective NNRTI-, and ritonavir-sparing regimen that could be an attractive option for both first and second line (after NRTI/NNRTI failure) treatment regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection HIV Infections |
Drug: raltegravir QD Drug: atazanavir Drug: lamivudine (or emtricitabine) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA) |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Raltegravir BID-QD: Experimental
Week 1-4
Week 5-8
|
Drug: raltegravir QD
Raltegravir 800mg QD
Drug: atazanavir
atazanavir
Drug: lamivudine (or emtricitabine)
lamivudine (or emtricitabine)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Burger, PhD, PharmD | ++31 24 3616405 | d.burger@akf.umcn.nl |
| Contact: Angela Colbers, MSc | ++31 24 3616405 | a.colbers@akf.umcn.nl |
| Germany | |
| University of Bonn | Not yet recruiting |
| Bonn, Germany | |
| Contact: J Rockstroh | |
| Principal Investigator: J Rockstroh | |
| Netherlands | |
| Rijnstate Hospital Arnhem | Not yet recruiting |
| Arnhem, Netherlands | |
| Contact: C Richter | |
| Principal Investigator: C Richter | |
| Erasmus Medical Center Rotterdam | Not yet recruiting |
| Rotterdam, Netherlands | |
| Contact: M van der Ende | |
| Principal Investigator: M van der Ende | |
| Radboud University Medical Centre Nijmegen | Recruiting |
| Nijmegen, Netherlands | |
| Contact: A van der Ven | |
| Principal Investigator: A van der Ven | |
| Principal Investigator: | David Burger | Radboud University |
More Information
| Responsible Party: | Radboud University Medical Centre Nijmegen ( D.M. Burger, PhD, PharmD ) |
| Study ID Numbers: | UMCN-AKF 08.07 |
| Study First Received: | July 21, 2009 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00943540 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
pharmacokinetics single dose raltegravir Treatment experienced |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Atazanavir Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |