NCT00939874

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: St Vincent's Hospital, Sydney · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HIV
• Osteopenia
• Osteoporosis
• HIV Infections

Interventions

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

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-06-01
• Completion: 2014-04-01
• First posted: 2009-07-15
• Last updated: 2015-06-12
• Results posted: 2015-06-12

Locations

4 sites across 1 country: Australia