Phase 4 N=52 Treatment

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

HIV · Osteopenia · Osteoporosis · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00939874 ↗

Enrolled (actual)

Serious AEs

13.5%

Results posted

Jun 2015

Primary outcome: Primary: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips — 2.7; 3.0; 2.3; 1.9 percent change — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Raltegravir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: St Vincent's Hospital, Sydney
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips	2.7; 3.0; 2.3; 1.9	<0.0001 sig
SECONDARY Percentage of Participants With HIV Viral Load <50 Copies/mL	90.6	—

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.

Eligibility Criteria

Inclusion Criteria

provision of written, informed consent
HIV-infected adults at least 18 years of age
receiving stable ART including TDF and a r/PI for the previous 6 months
no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
plasma HIV RNA 25% below lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00939874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.