Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Summary

This is a two-site, three-arm, open-label, pilot randomized controlled trial of bone anti-resorptive therapy during ART initiation in HIV-infected adults. Thirty (30) treatment-naïve HIV-infected adults initiating eligible first-line ART regimens will be randomized in a 1:1:1 fashion to one of the following three arms: 1. no bone anti-resorptive therapy (standard of care) 2. concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D; 3. a 24 week delay in initiation of a 24 week course of alendronate/vitamin D Assessments (including clinical evaluation, questionnaires, adherence, basic laboratory evaluation, and BMD measurement) will be performed at baseline, 24 and 48 weeks. The primary objective will involve calculation of σ and ρ using all data; δ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.

Timeline

Start

2014-04-23

Primary completion

2018-03-19

Completion

2018-03-19

Drugs

Indications