CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
change from tenofovir to raltegravirdrug
Likely dose
change from tenofovir to 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/NCT01044771
NCT01044771N/ACompleted

A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads

Metropolis Medical·interventional·Posted Jan 8, 2010·Updated May 12, 2015

In Brief

A clinical study evaluating change from tenofovir to raltegravir for HIV Infections and Proteinuria. Completed, enrolled 20 participants.

Detailed Summary

The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated. Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2010
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.5 years ago

Interventions

change from tenofovir to raltegravirdrug

Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID