HIV | Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial
HIV research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Documented HIV-1 infection - Adult (aged >18 years or as per local guidelines) - Premenopausal, if female - Antiretroviral-naïve - Starting first-line ART including tenofovir/emtricitabine with either efavirenz (co-formulated as Atripla®) or elvitegravir, cobicistat (co-formulated as Stribild®) - Low (<10%) ten-year fracture risk as assessed by the FRAX score validated for Canadian populations Exclusion Criteria: - Presence of established osteoporosis at baseline as determined by BMD measurement - Prior or current use of any bone anti-resorptive therapy (eg. bisphosphonate, estrogens with the exception of oral contraceptive pills, etc.) - Inability to communicate in English - Creatinine clearance <35 mL/min (using Cockcroft-Gault formula) - Hypersensitivity to alendronate, other bisphosphonates, or any component of the formulation - Hypocalcemia - Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia - Inability to stand or sit upright for at least 30 minutes - Pregnancy, active plans to become pregnant, or lactation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:alendronate/vitamin Donce weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
no bone anti-resorptive therapy(standard of care)
24-week tx of alendronate/vitamin DConcomitant initiation of a 24 week course of co-formulated alendronate/vitamin D
Delayed 24-week tx of alendronate/vitamin Da 24 week delay in initiation of a 24 week course of alendronate/vitamin D
Start Date: April 23, 2014
Completed Date: March 19, 2018
Phase: Phase 2
Primary Outcome: Percentage changes in BMD at a) the lumbar spine and b) proximal femur
Secondary Outcome: Feasibility
Study sponsors, principal investigator, and references
Principal Investigator: Darrell Tan, MD
Lead Sponsor: St. Michael's Hospital, Toronto
Collaborator: CIHR Canadian HIV Trials Network