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The Effect of Intermittent Rifampicin on Raltegravir

NCT01424826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-10-31

No results posted yet for this study

Summary

This study seeks to address the question of whether intermittent dosing of rifampicin influences the pharmacokinetics of raltegravir when co-administered. This study aims to look at what happens when rifampicin is taken 3 times a week with the standard dose and an increased dose of raltegravir. This is to find out the best dose of raltegravir to take when taking rifampicin 3 times a week. The study will be conducted in 18 healthy volunteers.

Conditions

Interventions

DRUG

Raltegravir

400 mg bd for minimum of 28 days and maximum 35 days

DRUG

Rifampicin

\< 50 kg 600 mg 3 times/week for a minimum of 27 days and maximum of 34 days \> 50 kg 900 mg 3 times/week for a minimum of 27 days and maximum of 34 days

DRUG

Raltegravir

800 mg bd for 4 days

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Helen Reynolds

    lead OTHER

Principal Investigators

  • Saye Khoo · University of Liverpool

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-07-31

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 NCT01424826 on ClinicalTrials.gov