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A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers

NCT01841593 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-09-29

Study results available
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Summary

The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the blood, and how it is affected if raltegravir is taken at the same time as another medicine for high blood pressure (amlodipine). Many patients with HIV will also have high blood pressure, so it is important to know which drugs for each of these conditions can be taken together without affecting how well they work individually.

Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks, with the middle week being on both drugs. The investigators will look at and compare the levels of these two drugs in the blood after subjects have taken them separately and both together.

This study is randomised into two groups with both study medications received by all participants in a three-period crossover pattern; randomisation determined which medication was taken first. Once randomised allocation was performed, medications were administered in an open-label fashion.

Conditions

Interventions

DRUG

Raltegravir

Isentress 400mg tablet taken twice daily

DRUG

Amlodipine

generic amlodipine 5mg tablets (Accord healthcare Limited, UK)

Sponsors & Collaborators

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito, Dr · St Stephen's AIDS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01841593 on ClinicalTrials.gov