Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study

NCT01073761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-08-16

No results posted yet for this study

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

More Related Trials

Entities

Diseases

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 NCT01073761 on ClinicalTrials.gov