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SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat

NCT02589158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-03-22

No results posted yet for this study

Summary

The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage.

If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order.

The participant and the study doctor will know which study medications the participant is taking at all times during the study.

Conditions

Interventions

DRUG

Evotaz

All participants will be administered Evotaz®) (atazanavir 300mg + cobicistat 150mg) once daily for 10 days

DRUG

Rezolsta

All participants will be administered Rezolsta® (darunavir 800mg + cobicistat 150mg) once daily for 10 days.

Sponsors & Collaborators

Principal Investigators

  • Marta Boffito · 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
2015-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02589158 on ClinicalTrials.gov