CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 19 enrolled
Drug / intervention
Raltegravir +1 moredrug
Likely dose
Raltegravir 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01841593
NCT01841593Phase 1Completed

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

St Stephens Aids Trust·interventional·Posted Apr 26, 2013·Updated Sep 29, 2014

In Brief

A Phase 1 clinical trial evaluating Raltegravir and Amlodipine for HIV. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2013
Enrollment StartApr 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.2 years ago

Interventions

Raltegravirdrug

Isentress 400mg tablet taken twice daily

Amlodipinedrug

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