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Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

NCT00939874 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-06-12

Study results available
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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.

Conditions

Interventions

DRUG

Raltegravir

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

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Holdsworth House Medical Practice

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • St Vincent's Hospital, Sydney

    lead OTHER

Principal Investigators

  • Andrew D Carr, Professor · St Vincents Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-06-30
Completion
2014-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939874 on ClinicalTrials.gov