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Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Information source: St. Michael's Hospital, Toronto
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: alendronate/vitamin D (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: St. Michael's Hospital, Toronto

Official(s) and/or principal investigator(s):
Darrell Tan, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto

Overall contact:
Darrell Tan, MD, Phone: 4168646060, Ext: 5568, Email: darrell.tan@gmail.com

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-na´ve 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 ¤â and ¤ü using all data; ╬┤ will be estimated by comparing the two alendronate arms pooled to the no-treatment arm.

Clinical Details

Official title: Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Percentage changes in BMD at a) the lumbar spine and b) proximal femur

Secondary outcome:

Feasibility

Acceptability

Safety/Tolerability

Adherence

Bone Biomarkers

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Darrell Tan, MD, Phone: 4168646060, Ext: 5568, Email: darrell.tan@gmail.com

St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting
Darrell Tan, MD, Phone: 4168646060, Ext: 77505, Email: darrell.tan@gmail.com
Darrell Tan, MD, Principal Investigator

Toronto General Hospital, Toronto, Ontario M5G 2N2, Canada; Recruiting
Sharon Walmsley, MD, Phone: 4163403871, Email: sharon.walmsley@uhn.com
Sharon Walmsley, MD, Principal Investigator

Additional Information

Starting date: May 2014
Last updated: February 4, 2015

Page last updated: August 20, 2015

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