CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Raltegravir +2 moredrug
Likely dose
Raltegravir 400 mgfrom 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/NCT01335620
NCT01335620Phase 4Completed
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An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

Imperial College London·interventional·Posted Apr 14, 2011·Updated Nov 20, 2019

In Brief

A Phase 4 clinical trial evaluating Raltegravir, Tenofovir, and 1 other intervention for HIV. Completed, enrolled 19 participants across 2 sites.

Detailed Summary

This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study. Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to: * tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus * raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2011
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.2 years ago

Interventions

Raltegravirdrug

400 mg twice daily

Tenofovirdrug

245 mg once daily

Emtricitabinedrug

200mg once daily