CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Tenofovir/emtricitabine +2 moredrug
Likely dose
Tenofovir/emtricitabine 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/NCT01270802
NCT01270802Phase 4Completed
CompareCT.gov

A Randomized Controlled Pilot Trial Comparing Continued Antiretroviral Therapy With Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) With Switch to Tenofovir/Emtricitabine/Raltegravir (TDF/FTC/RAL) on Changes in Endothelial Function and Markers of Bone Metabolism

Indiana University·interventional·Posted Jan 5, 2011·Updated Dec 18, 2013

In Brief

A Phase 4 clinical trial evaluating Tenofovir/emtricitabine, Tenofovir/emtricitabine/efavirenz, and 1 other intervention for HIV. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a newer HIV medication, will improve vascular function and tests of bone health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.5 years ago

Interventions

Tenofovir/emtricitabinedrug

Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine

Tenofovir/emtricitabine/efavirenzdrug

Continued therapy with tenofovir/emtricitabine/efavirenz

Raltegravirdrug

Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine