Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study
NCT01073761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2010-08-16
Summary
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.
Conditions
- HIV
- HIV Infections
Interventions
- 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
Sponsors & Collaborators
-
St Stephens Aids Trust
lead OTHER
Principal Investigators
-
Marta Boffito, Dr · St Stephen's AIDS Trust
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- United Kingdom
Study Locations
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