CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Raltegravirdrug
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/NCT00939874
NCT00939874Phase 4Completed
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Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

St Vincent's Hospital, Sydney·interventional·Posted Jul 15, 2009·Updated Jun 12, 2015

In Brief

A Phase 4 clinical trial evaluating Raltegravir for HIV and 3 related conditions. Completed, enrolled 52 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir to another HIV medication raltegravir. Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Osteopenia, Osteoporosis, HIV Infections
CountriesAustralia
CollaboratorsMerck Sharp & Dohme LLC, Holdsworth House Medical Practice, The Alfred

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2009
Enrollment StartOct 1, 2009
Primary CompletionJun 1, 2012
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.0 years ago

Interventions

Raltegravirdrug

Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.