Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01968850 | Bone Antiresorptive Therapy With Antiretroviral Initiation (BATARI) Pilot Trial | PHASE2 | COMPLETED | 30 | — | — | Apr 23, 2014 | Mar 19, 2018 | Apr 19, 2018 | 2 | Canada |
The primary analysis will compare the percentage changes in BMD for the two alendronate/vitamin D arms pooled against the control arm.
| Arm | Type | Description |
|---|---|---|
| no bone anti-resorptive therapy | NO_INTERVENTION | (standard of care) |
| 24-week tx of alendronate/vitamin D | EXPERIMENTAL | Concomitant initiation of a 24 week course of co-formulated alendronate/vitamin D |
| Delayed 24-week tx of alendronate/vitamin D | EXPERIMENTAL | a 24 week delay in initiation of a 24 week course of alendronate/vitamin D |
| Name | Type | Description |
|---|---|---|
| alendronate/vitamin D | DRUG | once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks. |
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-formu...