Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study
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|ClinicalTrials.gov Identifier: NCT01073761|
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : August 16, 2010
The purpose of the study is to look at the levels of three HIV medications darunavir, ritonavir and atazanavir in the blood after the drug intake has been stopped in order to understand how long these drugs persist in blood for. The study will specifically look at these three drugs blood levels after taking them for 10 days everyday.
The main objective is to provide information on the potential safety (in terms of preventing virological failure and the development of resistance)of delaying drug doses occasionally by providing information on the decline in drug concentration after dosing has stopped.
|Condition or disease||Intervention/treatment||Phase|
|HIV HIV Infections||Drug: darunavir/ritonavir then atazanavir/ritonavir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Darunavir/Ritonavir Once Daily and Atazanavir/Ritonavir Once Daily Over 72 Hours Following Drug Intake Cessation|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
All Subjects will receive the same intervention
Drug: darunavir/ritonavir then atazanavir/ritonavir
Phase 1: Oral darunavir/ritonavir 800/100 mg once daily for 10 days
Phase 2: Oral atazanavir/ritonavir 300/100 mg once daily for 10 days
- Pharmacokinetics [ Time Frame: 30 days (excluding screening and follow-up) ]To assess the pharmacokinetics of darunavir/ritonavir once daily and atazanavir/ritonavir once daily over 72 hours following drug intake cessation
- Inter-Subject Variability [ Time Frame: 30 days ]To assess the inter subject variability in darunavir and atazanavir plasma concentrations over 72 hours following drug intake cessation.
- Safety and Tolerability [ Time Frame: 30 day (excluding screening and follow up) ]To assess the safety and tolerability of darunavir/ritonavir and atazanavir/ritonavir over 10 days of administration
- Pharmacogenetics [ Time Frame: 30 day (excluding screening and follow up) ]To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073761
|St Stephen's Centre|
|London, United Kingdom, SW10 9TH|
|Principal Investigator:||Marta Boffito, Dr||St Stephen's AIDS Trust|